Publications by authors named "Andrea Tacchino"

57 Publications

Instrumentally assessed gait quality is more relevant than gait endurance and velocity to explain patient-reported walking ability in early-stage multiple sclerosis.

Eur J Neurol 2021 Apr 17. Epub 2021 Apr 17.

IRCSS Fondazione Don Carlo Gnocchi, Milan, Italy.

Background And Purpose: People with multiple sclerosis (PwMS) often report walking limitations even when the gold standard Expanded Disability Status Scale (EDSS) indicates normal walking endurance/autonomy. The present multicenter study on early-stage PwMS aims at analyzing which aspects are associated with patient-reported walking limitations measured with the 12-item Multiple Sclerosis Walking Scale (MSWS-12).

Methods: Eighty-two PwMS (EDSS ≤ 2.5) were assessed using the Fullerton Advanced Balance Scale-short (FAB-s), the Fatigue Severity Scale (FSS) and the 6-min Walk Test (6MWT), the latter administered also to 21 healthy subjects. Participants performed the 6MWT wearing three inertial sensors on ankles and trunk. Instrumented metrics describing gait velocity (stride length and frequency) and quality (regularity, symmetry, instability) were computed from sensor data. Fatigue (FSS), balance (FAB-s), walking endurance (6MWT) and instrumented metrics were entered in a multiple regression model with MSWS-12 as dependent variable.

Results: Gait symmetry, gait instability, fatigue and balance were significantly associated with self-rated walking ability, whilst walking endurance and velocity were not. Fatigue, balance, gait symmetry and instability were more impaired in participants reporting mild-to-moderate (MS , 25 ≤ MSWS-12 < 75) compared to those reporting none-to-minimal (MS , 0 ≤ MSWS-12 ≤ 25) perceived walking limitations. Compared to healthy subjects, gait symmetry and stability were reduced in MS and MS , even in those participants with EDSS ≤ 1.5.

Conclusion: Instrumentally assessed gait quality aspects (symmetry and instability) are associated with patient-reported walking ability in early-stage PwMS and seem sensitive biomarkers to detect subtle impairments even in the earliest stages of the disease (EDSS ≤ 1.5). Future studies should assess their ability to follow walking change due to MS progression or pharmacological/rehabilitation interventions.
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http://dx.doi.org/10.1111/ene.14866DOI Listing
April 2021

Predominant cognitive phenotypes in multiple sclerosis: Insights from patient-centered outcomes.

Mult Scler Relat Disord 2021 Mar 21;51:102919. Epub 2021 Mar 21.

Scientific Research Area, Italian Multiple Sclerosis Foundation, Genoa, Italy.

Background: Since combining information from different domains could be useful to increase prediction accuracy over and above what can be achieved at the level of single category of markers, this study aimed to identify distinct and predominant subtypes, i.e., cognitive phenotypes, in people with multiple sclerosis (PwMS) considering both cognitive impairment and mood disorders.

Methods: A latent class analysis (LCA) was applied on data from 872 PwMS who were tested with Montreal Cognitive Assessment (MoCA), Symbol Digit Modalities Test (SDMT) and Hospital Anxiety and Depression Scale (HADS). Furthermore, the distribution of demographic (i.e., age, gender, years of education) and clinical characteristics (i.e., disease duration, disease course, disability level) was examined amongst the identified phenotypes.

Results: Based on model fit and parsimony criteria, LCA identified four cognitive phenotypes: 1) only memory difficulties (n = 247; 28.3%); 2) minor memory and language deficits with mood disorders (n = 185; 21.2%); 3) moderate memory, language and attention impairments (n = 164; 18.8%); 4) severe memory, language, attention, information processing and executive functions difficulties (n = 276; 31.7%).

Conclusions: Since less is known about the progressive deterioration of cognition in PwMS, a taxonomy of distinct subtypes that consider information from different clustered domains (i.e., cognition and mood) represents both a challenge and opportunity for an advanced understanding of cognitive impairments and development of tailored cognitive treatments in MS.
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http://dx.doi.org/10.1016/j.msard.2021.102919DOI Listing
March 2021

Differential effects and discriminative validity of motor and cognitive tasks varying in difficulty on cognitive-motor interference in persons with multiple sclerosis.

Mult Scler 2021 Feb 10:1352458520986960. Epub 2021 Feb 10.

REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Hasselt, Belgium.

Background: Cognitive-motor interference (CMI) has been well recognized in persons with multiple sclerosis (pwMS); however, there are limited data on effects of task difficulty.

Objective: Examine (1) the effects of motor and cognitive tasks varying in difficulty on the magnitude of CMI and (2) the discriminative validity of CMI between pwMS and healthy controls (HC).

Methods: Nine cognitive-motor dual-task (DT) conditions (combinations of three cognitive and three walking tasks) were examined. Outcome measures were DT-performance and dual-task cost (DTC) of gait parameters and correct answers. Task differences and overall group-effects were analysed by mixed model analysis, plus the Wilcoxon signed-rank tests or multivariate analysis of variances (MANOVAs), respectively.

Results: Task effects were examined in 82 pwMS (Expanded Disability Status Scale (EDSS): 3.3 ± 1.0) and discriminative validity in a subsample (35 pwMS and 33 HC). Motor-DTC and DT-performance were affected by difficulty of both the cognitive task ( < 0.001) and the walking condition ( ⩽ 0.002), while cognitive-DTC only varied between cognitive tasks with a large difference in difficulty ( ⩽ 0.005) and not between walking conditions ( ⩾ 0.125). None of the DTCs differed between groups.

Conclusion: CMI, and especially motor performance, is affected by difficulty of the DT. Although pwMS performed worse on the tasks than HC, none of the DT-conditions showed a discriminative DTC.
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http://dx.doi.org/10.1177/1352458520986960DOI Listing
February 2021

Prevalence and patterns of subclinical motor and cognitive impairments in non-disabled individuals with early multiple sclerosis: a multicenter cross-sectional study.

Ann Phys Rehabil Med 2021 Jan 14:101491. Epub 2021 Jan 14.

Rehabilitation Department, CRRF Mons L Novarese, 13040 Loc. Trompone, Moncrivello VC, Italy.

Background: Motor and cognitive disorders appear early in the course of multiple sclerosis (MS) and develop gradually over time.

Objective: To study the frequency and pattern of subtle functional disorders in people with MS (PwMS) with no overt signs of disability in an early phase of the disease and their association with walking impairments in daily activities.

Methods: In this cross-sectional study, we recruited PwMS with an Expanded Disability Status Scale (EDSS) score ≤ 2.5 and disease duration ≤ 5 years. Participants were assessed with functional scales rating walking endurance (6-Min Walk Test), perceived walking ability (Twelve-item Multiple Sclerosis Walking Scale), balance (Fullerton Advanced Balance scale_short), manual dexterity (Nine Hole Peg Test), fatigue (Fatigue Severity Scale), and cognitive impairments (Brief International Cognitive Assessment).

Results: About 90% of the 82 PwMS (mean [SD] EDSS score 1.5 [0.7] and disease duration 2.2 [1.7] years) showed endurance values below the expected score; almost 30% showed impairment, and for 57%, perceived walking ability score was abnormal. Balance was impaired in 48% of participants, as was manual dexterity (29%) and fatigue (24%), but only a few showed cognitive impairments. Only 11% of PwMS had no abnormal score on the scales used in the assessment. As compared with EDSS score 0 to 1.5, with EDSS score 2 to 2.5, performance was worse for endurance (difference ±61.0 m, p=0.016), perceived walking ability (-11 points, p=0.002), balance (+1.9 points, p=0.005), manual dexterity (-2.8 sec, p=0.004), and fatigue (-1.3 points, p=0.013). Factors that predicted perceived walking ability were balance (B = -1.37, p<0.001) and fatigue (B = 5.11, p<0.001) rather than endurance (B = -0.01, p=048).

Conclusion: Even PwMS with no clinical disability and classified as having "no problem walking" present walking and other functional deficits when assessed with specific functional tests. The addition of specific tools could better identify subtle motor and cognitive deficits. Finally, the assessment of balance disorders and fatigue is important to understand individuals' perceived walking impairments in daily activities.
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http://dx.doi.org/10.1016/j.rehab.2021.101491DOI Listing
January 2021

Spatial constraints and cognitive fatigue affect motor imagery of walking in people with multiple sclerosis.

Sci Rep 2020 12 14;10(1):21938. Epub 2020 Dec 14.

Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), Genoa, Italy.

Motor imagery (MI) is the mental simulation of an action without any overt motor execution. Interestingly, a temporal coupling between durations of real and imagined movements, i.e., the so-called isochrony principle, has been demonstrated in healthy adults. On the contrary, anisochrony has frequently been reported in elderly subjects or those with neurological disease such as Parkinson disease or multiple sclerosis (MS). Here, we tested whether people with MS (PwMS) may have impaired MI when they imagined themselves walking on paths with different widths. When required to mentally simulate a walking movement along a constrained pathway, PwMS tended to overestimate mental movement duration with respect to actual movement duration. Interestingly, in line with previous evidence, cognitive fatigue was found to play a role in the MI of PwMS. These results suggest that investigating the relationship between cognitive fatigue and MI performances could be key to shedding new light on the motor representation of PwMS and providing critical insights into effective and tailored rehabilitative treatments.
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http://dx.doi.org/10.1038/s41598-020-79095-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7736576PMC
December 2020

Mam36 and Abilhand as outcome measures of multiple sclerosis hand disability: an observational study.

Eur J Phys Rehabil Med 2020 Dec 11. Epub 2020 Dec 11.

Italian Multiple Sclerosis Society Research Foundation - FISM, Genoa, Italy.

Background: Impaired upper limb functionality and dexterity are common in people with multiple sclerosis (PwMS) and lead to increased dependency and reduced quality of life.

Aim Of The Study: To Compare the ability of the Manual Abilites Measure 36 (MAM-36) and the Abilhand questionnaire to recognize an involvement of the upper limbs in PwMS, and to compare their results with those of other patient reported outcomes (PRO) evaluating disability, functional independence, symptoms of anxiety and depression, fatigue and quality of life.

Design: Observational study.

Setting: Outpatient.

Population: 51 PwMS (mean age 56,31 years, age range 33-82 years, 72,5% females).

Methods: For each patient were collected MAM-36, Abilhand questionnaire, expanded disability status scale (EDSS), Functional Independence measure (FIM), Hospital Anxiety and Depression Scale (HADS), Modified Fatigue Impact Scale (MFIS) and Life Satisfaction Index (LSI).

Results: A strong correlation between MAM-36 and the Abilhand questionnaire (Spearman r: 0.79; p<0.0001) were found. We obtained a significant correlation between MAM-36 and EDSS (Spearman r: -0.5; p= 0.0002), FIM (Spearman r: 0.55; p<0.0001); we did not observe a correlation with MFIS (Spearman r: -0.33; p: 0.02); moreover we found a similar trend between Abilhand and EDSS (Spearman r: -0.47; p= 0.0005), FIM (Spearman r: 0.61; p<0.0001), MFIS (Spearman r: -0.41; p: 0.002).

Conclusions: In PwMS the assessment of upper limbs is fundamental since it closely related to the level of disability of the person. Both MAM-36 and Abilhand Questionnaire are equally able to detect upper limb dysfunctions in PwMS.

Clinical Rehabilitation Impact: Both MAM-36 and Abilhand can be used for upper limbs evaluation, within a multidimensional approach that seems to be the best way to evaluate PwMS.
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http://dx.doi.org/10.23736/S1973-9087.20.06446-1DOI Listing
December 2020

Focus on neglected features of cognitive rehabilitation in MS: Setting and mode of the treatment.

Mult Scler 2020 Oct 13:1352458520966300. Epub 2020 Oct 13.

Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), Genoa, Italy/AISM Rehabilitation Center, Italian Multiple Sclerosis Society, Genoa, Italy.

Cognitive rehabilitation in multiple sclerosis (MS) aims at reducing patients' cognitive impairments, improving their awareness and ability to take cognitive difficulties into account in their daily living. However, at this moment, more high-quality randomized trials are needed to draw conclusion about the effectiveness of cognitive interventions in MS. Although existing studies provide clear descriptions of intervention key ingredients (e.g. targeted cognitive domain as well as treatment frequency and duration) and the practical details needed to manage these key elements (e.g. restorative approaches, compensatory strategies, or environmental modifications), other crucial aspects received less attention in rehabilitation research. The aim of this topical review is to try to elucidate some critical issues that were only partly addressed and analyzed by the scientific literature: setting (center-based vs home-based) and mode (individual vs group) of the cognitive rehabilitation treatment.
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http://dx.doi.org/10.1177/1352458520966300DOI Listing
October 2020

Predictors of clinically significant anxiety in people with multiple sclerosis: A one-year follow-up study.

Mult Scler Relat Disord 2020 Oct 22;45:102417. Epub 2020 Jul 22.

Scientific Research Area, Italian Multiple Sclerosis Foundation, Genoa, Italy.

Background: Mood disorders, such as depression and anxiety, are frequent in people with Multiple Sclerosis (PwMS). Although anxiety has a well-recognized negative influence on family, work and social life, it has received less attention than depression. Thus, it is still under debate which risk factors can predict anxiety, its evolution over time and the extent of its effect on disability progression.

Objective: The aim of this retrospective study was to identify potential demographic, clinical and self-reported predictors that contribute to clinically significant anxiety at one-year follow up, measured by the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS).

Methods: Data was acquired from a cohort of 608 subjects with MS, and included domains potentially meaningful for clinically significant anxiety. Associations between each variable and clinically significant anxiety at one-year follow-up were assessed with univariate and multivariate logistic regression analyses.

Results: Lower educational level, relapsing-remitting disease course, presence of clinically significant anxiety at baseline, higher depression and fatigue perception were significant predictors for clinically significant anxiety at one-year follow up.

Conclusion: Findings confirm the importance of identifying risk factors for clinically significant anxiety in predicting prognosis and planning early intervention.
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http://dx.doi.org/10.1016/j.msard.2020.102417DOI Listing
October 2020

Lower urinary tract dysfunction in patients with multiple sclerosis: A post-void residual analysis of 501 cases.

Mult Scler Relat Disord 2020 Oct 5;45:102378. Epub 2020 Jul 5.

Italian Multiple Sclerosis Society, AISM Rehabilitation Centre, Genoa, Italy; Italian Multiple Sclerosis Society Research Foundation - FISM, Genoa, Italy.

Introduction: Lower urinary tract symptoms (LUTS) are common in individuals with multiple sclerosis (MS), and can have a significant impact on quality of life (QoL). Prevalence of LUTS in MS ranges from 32% to 96.8%, including storage or voiding symptoms or a combination of these. Post-void residual (PVR) is a very well-tolerated, non-invasive test for evaluating voiding dysfunction. The aim of the current study was to describe the distribution of PVR volumes across MS subjects with and without LUTS and to examine relationships between storage symptoms, voiding symptoms, and PVR.

Methods: A large group of subjects (N = 501) completed a questionnaire on LUTS (current bladder management, number of urinary tract infections in the last year and urological investigations). A bladder ultrasound for PVR was performed and data were collected. We used Chi-Square and the Mann-Whitney non-parametric tests respectively for categorical and continuous variables in order to assess differences between symptomatic and asymptomatic groups. The differences of PVR by LUTS status were explored using the Mann-Whitney non-parametric test for independent samples.

Results: Overall mean PVR was 132.4 mL (PVR>100 ml was considered an abnormal residual urine volume). Based on the LUTS questionnaire, 43 subjects (8.6%) were asymptomatic, while 458 subjects (91.4%) reported at least one LUTS. Storage-related symptoms were reported by 87.2% of subjects (437) and 65.1% (326) reported at least one voiding-related symptom. Two-third of subjects (66.5%) reported three or more LUTS. There was a statistically significant association between the presence of LUTS and the number of infections reported (p = 0.0015). The symptomatic group had significantly higher PVR than the asymptomatic group (p = 0.011). PVR significantly correlated with male gender, disability level and a progressive disease course.

Conclusion: Results showed a high prevalence of LUTS in subjects with MS and that storage symptoms are predominant. There was an association between the presence of LUTS and a progressive disease course. The relationship between LUTS, higher PVR and the severity of disease course indicates that a comprehensive clinical evaluation should include an assessment of both neurological and micturition disorders and, importantly, PVR should be measured at every clinical assessment, despite the presence or absence of LUTS.
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http://dx.doi.org/10.1016/j.msard.2020.102378DOI Listing
October 2020

Exergames for balance dysfunction in neurological disability: a meta-analysis with meta-regression.

J Neurol 2020 May 23. Epub 2020 May 23.

Rehabilitation Unit 'Mons. L. Novarese' Hospital, Loc. Trompone, 13040, Moncrivello, VC, Italy.

Objective: To evaluate systematically the efficacy of exergames for balance dysfunction in neurological conditions and to identify factors of exergaming protocols that may influence their effects.

Methods: We searched electronic databases for randomized clinical trials investigating the effect of commercial exergames versus alternative interventions on balance dysfunction as assessed by standard clinical scales in adults with acquired neurological disabilities. Standardized mean differences (Hedge's g) were calculated with random-effects models. Subgroup analyses and meta-regression were run to explore potential modifiers of effect size.

Results: Out of 106 screened articles, 41 fulfilled criteria for meta-analysis, with a total of 1223 patients included. Diseases under investigation were stroke, Parkinson's disease, multiple sclerosis, mild cognitive impairment or early Alzheimer's disease, traumatic brain injury, and myelopathy. The pooled effect size of exergames on balance was moderate (g = 0.43, p < 0.001), with higher frequency (number of sessions per week) associated with larger effect (β = 0.24, p = 0.01). There was no effect mediated by the overall duration of the intervention and intensity of a single session. The beneficial effect of exergames could be maintained for at least 4 weeks after discontinuation, but their retention effect was specifically explored in only 11 studies, thus requiring future investigation. Mild to moderate adverse events were reported in a minority of studies. We estimated a low risk of bias, mainly attributable to the lack of double-blindness and not reporting intention-to-treat analysis.

Conclusions: The pooled evidence suggests that exergames improve balance dysfunction and are safe in several neurological conditions. The findings of high-frequency interventions associated with larger effect size, together with a possible sustained effect of exergaming, may guide treatment decisions and inform future research.
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http://dx.doi.org/10.1007/s00415-020-09918-wDOI Listing
May 2020

Italian validation of the Arm Function in Multiple Sclerosis Questionnaire (AMSQ).

Neurol Sci 2020 Nov 12;41(11):3273-3281. Epub 2020 May 12.

Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), via Operai 40, 16149, Genoa, Italy.

Introduction: Arm and hand function deficits are commonly in people with multiple sclerosis (PwMS). The Arm Function in Multiple Sclerosis Questionnaire (AMSQ) is a novel self-administered instrument specifically developed to evaluate upper limb function in MS. The aim of this study was to translate and adapt the AMSQ into Italian and to assess its psychometric properties in PwMS. Validity (structural, construct, and known-groups) and reliability (internal consistency, test-retest, and measurement error) were assessed.

Materials And Methods: From June 2017 to February 2018, a prospective cohort of PwMS among those followed as outpatients at the Rehabilitation Services of the Italian Multiple Sclerosis Society (AISM) of Genoa, Padua, and Vicenza was involved in the study. Construct validity of AMSQ was determined by examining correlations with the Italian version of ABILHAND, Modified Fatigue Impact Scale (MFIS), and Functional Independence Measure (FIM).

Results: A total of 234 PwMS were enrolled. The mean AMSQ total score was 67.3 (SD = 38.4). Factor analysis results suggested one factor. As expected, moderate to high correlation coefficients were found between AMSQ and ABILHAND (- 0.79), MFIS (0.50) and its subsets, and FIM (- 0.60) and its subsets involving upper limb functioning. PwMS with higher EDSS reported worse total score of AMSQ than patients with low disability. The internal consistency of the 31 items was high (Cronbach's α, 0.98). Test-retest reliability, as measured with ICC, was 0.96 (95% IC, 0.93-0.98), and measurement error was about 8.3 points showing good reliability.

Discussion: AMSQ has been adapted and validated, it is a reliable questionnaire for Italian PwMS.
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http://dx.doi.org/10.1007/s10072-020-04363-zDOI Listing
November 2020

Assessing balance in non-disabled subjects with multiple sclerosis: Validation of the Fullerton Advanced Balance Scale.

Mult Scler Relat Disord 2020 Jul 13;42:102085. Epub 2020 Apr 13.

IRCSS Fondazione Don Carlo Gnocchi, Via Capecelatro 66, 20148 Milan Italy.

Objective: To validate the Fullerton Advanced Balance (FAB) scale for high-functioning non-disabled people with multiple sclerosis (PwMS).

Design: Cross-sectional study.

Participants: A convenience sample of early-diagnosed PwMS (N = 82; Expanded Disability Status Scale score ≤ 2.5) with disease duration ≤ 5 years and a control group of healthy volunteers (N = 45).

Main Outcome Measures: FAB scale, Timed Up and Go test (TUG), 6 Min Walk Test (6MWT) and 25 Foot Walk Test (25FWT).

Results: Six of the ten original FAB scale items were selected to represent a unidimensional construct. Only one factor with eigenvalues > 1.0 (1.90) was found. The new version of the scale reported a Cronbach alpha value of 0.65, and it was also statistically significantly correlated with TUG (r = -0.48). The new six-item scale, dubbed the FAB-short scale (FAB-s), discriminated between healthy volunteers and PwMS; moreover, both the FAB-s and the TUG test discriminated between the two PwMS subgroups: EDSS=0-1.5 (no disability) and EDSS=2-2.5 (minimal disability).

Conclusions: FAB-s is a unidimensional clinical tool for assessing balance. The scale is a promising instrument for detecting subtle changes in balance performance in high-functioning PwMS.
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http://dx.doi.org/10.1016/j.msard.2020.102085DOI Listing
July 2020

Local Dynamic Stability of Gait in People With Early Multiple Sclerosis and No-to-Mild Neurological Impairment.

IEEE Trans Neural Syst Rehabil Eng 2020 06 30;28(6):1389-1396. Epub 2020 Apr 30.

Poor dynamic balance, such as poor walking stability, is a hallmark of multiple sclerosis. Instrumental measures of local dynamic stability (LDS, e.g. short-term Lyapunov's exponents, sLyEs) are genuine measures of walking stability and increasingly used as dynamic balance indicators. The current work aims to investigate if people with multiple sclerosis (PWMS) with no clinical evidence of gait impairment suffer poor LDS of gait. Eighty PWMS with minimal impairment (EDSS ≤2.5) and twenty controls completed the Six-Minute Walk Test (6MWT) at their maximum speed, wearing inertial sensors. sLyEs were calculated from trunk vertical, mediolateral and anteroposterior (sLyE) acceleration. PWMS also completed a full clinical assessment including gait, balance and fatigue. Gait speed was lower in PWMS than controls (-15%), while sLyEs were larger in PWMS (+12%), even when adjusting for the different gait speed. High sLyE was associated with low gait speed, high impact of disease (including high fatigue) and poor balance, the three variables returned by a principal component analysis of the dataset of clinical measures. PWMS suffer poor LDS of gait, as indicated by large sLyEs. The association between high sLyE and poor balance supports the validity of sLyE as a dynamic balance measure. The inverse relationship between sLyE and gait speed is in line with the view that good balance is decisive for high gait speed. Finally, these findings are in line with the vicious circle linking poor balance and fatigue in PWMS, with fatigue worsening balance and poor balance leading to fatigue.
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http://dx.doi.org/10.1109/TNSRE.2020.2991636DOI Listing
June 2020

Design, Development, and Testing of an App for Dual-Task Assessment and Training Regarding Cognitive-Motor Interference (CMI-APP) in People With Multiple Sclerosis: Multicenter Pilot Study.

JMIR Mhealth Uhealth 2020 04 16;8(4):e15344. Epub 2020 Apr 16.

Rehabilitation Research Center (REVAL), Faculty of Rehabilitation Sciences, Hasselt University, Hasselt, Belgium.

Background: Dual tasking constitutes a large portion of most activities of daily living; in real-life situations, people need to not only maintain balance and mobility skills, but also perform other cognitive or motor tasks at the same time. Interest toward dual-task training (DTT) is increasing as traditional interventions may not prepare patients to adequately face the challenges of most activities of daily living. These usually involve simultaneous cognitive and motor tasks, and they often show a decline in performance. Cognitive-motor interference (CMI) has been investigated in different neurological populations, but limited evidence is present for people with multiple sclerosis (MS). The use of computerized tools is mandatory to allow the application of more standardized assessment and rehabilitation intervention protocols and easier implementation of multicenter and multilanguage studies.

Objective: To describe the design and development of CMI-APP, an adaptive and interactive technology tablet-based app, and to present the preliminary results of a multicenter pilot study involving people with MS performed in several European centers for evaluating the feasibility of and adherence to a rehabilitation program based on CMI-APP.

Methods: CMI-APP includes user-friendly interfaces for personal data input and management, assessment of CMI, and DTT. A dedicated team developed CMI-APP for Android tablets above API level 14 (version 4.0), using C# as the programming language and Unity and Visual Studio as development tools. Three cognitive assessment tests for working memory, information processing speed, and sustained attention and four motor assessment tests for walking at different difficulty levels were implemented. Dual cognitive-motor tasks were performed by combining single cognitive and motor tasks. CMI-APP implements exercises for DTT involving the following 12 cognitive functions: sustained attention, text comprehension, verbal fluency, auditory discrimination, visual discrimination, working memory, information processing speed, auditory memory, visual memory, verbal analog reasoning, visual analog reasoning, and visual spatial planning, which can be performed during walking or stepping on the spot. Fifteen people with MS (mean age 52.6, SD 8.6 years; mean disease duration 9.4, SD 8.4 years; mean Expanded Disability Status Scale score 3.6, SD 1.1) underwent DTT (20 sessions). Adherence to the rehabilitation program was evaluated according to the percentage of performed sessions, perceived exertion during the training (Borg 15-point Ratings of Perceived Exertion [RPE] Scale), and subjective experience of the training (Intrinsic Motivation Inventory [IMI]).

Results: The adherence rate was 91%. DTT was perceived as "somewhat difficult" (mean RPE Scale score 12.6, SD 1.9). IMI revealed that participants enjoyed the training and felt that it was valuable and, to some extent, important, without feelings of pressure. They felt competent, although they did not always feel they could choose the exercises, probably because the therapist chose the exercises and many exercises had few difficulty levels.

Conclusions: CMI-APP is safe, highly usable, motivating, and well accepted for DTT by people with MS. The findings are fundamental for the preparation of future large-sample studies examining CMI and the effectiveness of DTT interventions with CMI-APP in people with MS.
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http://dx.doi.org/10.2196/15344DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7218603PMC
April 2020

Italian translation and psychometric validation of the Manual Ability Measure-36 (MAM-36) and its correlation with an objective measure of upper limb function in patients with multiple sclerosis.

Neurol Sci 2020 Jun 23;41(6):1539-1546. Epub 2020 Jan 23.

Department of Psychology, University of Turin, Turin, Italy.

Background: Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system with an unpredictable course. During its course, deficits affecting upper limb functions may occur. Hence, there is a need for self-administered scales providing a comprehensive assessment of upper limb functions. The Manual Ability Measure-36 (MAM-36), which investigates patients' performance in activities of daily living requiring upper limb function, has not been adapted and validated in the Italian context.

Objectives: We develop an Italian translation and validation of the MAM-36 in a population of people with MS (PwMS), explore its psychometric properties and investigate its associations with clinical data and the Nine Hole Peg Test (9-HPT).

Research Plan And Methods: The multicentre study involved five Italian neurological centres. Subjects were evaluated using EDSS, 9-HPT and the MAM-36 scale. We used confirmatory factor analysis and Rasch analysis to investigate the properties of the MAM-36.

Results: We enrolled 218 PwMS. Results supported the unidimensionality of the MAM-36, and adequate functioning of rating scale and items. Additionally, the MAM-36 showed weak negative associations with age and disease duration, and moderate associations with EDSS and 9-HPT scores.

Discussion: The adapted MAM-36 showed adequate psychometric properties. However, indications of problematic targeting to PwMS with low disability emerged. For this reason, use of the scale appears to be more suitable among patients with moderate-to-severe disability.
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http://dx.doi.org/10.1007/s10072-020-04263-2DOI Listing
June 2020

Differential item functioning of the Arm function in Multiple Sclerosis Questionnaire (AMSQ) by language, a study in six countries.

Mult Scler 2021 01 17;27(1):90-96. Epub 2019 Dec 17.

Department of Epidemiology and Biostatistics, Amsterdam UMC, Location VUmc and Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.

Background: The Arm function in Multiple Sclerosis Questionnaire (AMSQ) has been developed as a self-reported measure of arm and hand functioning for patients with multiple sclerosis (MS). The AMSQ was originally developed in Dutch and to date translated into five languages (i.e. English, German, Spanish, French, and Italian).

Objective: The aim of this study was to evaluate differential item functioning (DIF) of the AMSQ in these languages.

Methods: We performed DIF analyses, using "language" as the polytomous group variable. To detect DIF, logistic regression and item response theory principles were applied. Multiple logistic regression models were evaluated. We used a pseudo value of 0.02 or more as the DIF threshold.

Results: A total of 1733 male and female patients with all subtypes of MS were included. The DIF analysis for the whole dataset showed no uniform or non-uniform DIF on any of the 31 items. All values were below 0.02.

Conclusion: The AMSQ is validated in six languages. All items have the same meaning to MS patients in Dutch, English, German, Spanish, French, and Italian. This validation study enables use of the AMSQ in international studies, for monitoring treatment response and disease progression.
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http://dx.doi.org/10.1177/1352458519895450DOI Listing
January 2021

Structured Cognitive-Motor Dual Task Training Compared to Single Mobility Training in Persons with Multiple Sclerosis, a Multicenter RCT.

J Clin Med 2019 Dec 10;8(12). Epub 2019 Dec 10.

REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, 3500 Hasselt, Belgium.

The aim was to compare the effectiveness of dual-task training (DTT) compared to single mobility training (SMT) on dual-task walking, mobility and cognition, in persons with Multiple Sclerosis (pwMS). Forty pwMS were randomly assigned to the DTT or SMT groups. The DTT-group performed dual-task exercises using an interactive tablet-based application, while the SMT-group received conventional walking and balance exercises. Both interventions were supervised and identical in weeks (8) and sessions (20). Nine cognitive-motor dual-task conditions were assessed at baseline, after intervention and at 4-weeks follow-up (FU). The dual-task cost (DTC), percentage change of dual-task performance compared to single-task performance, was the primary outcome. Mobility and cognition were secondarily assessed. Mixed model analyses were done with group, time and the interaction between group and time as fixed factors and participants as random factors. Significant time by group interactions were found for the digit-span walk and subtraction walk dual-task conditions, with a reduction in DTC (gait speed) for the DTT maintained at FU. Further, absolute dual-task gait speed during walking over obstacles only improved after the DTT. Significant improvements were found for both groups in various motor and cognitive measures. However, the DTT led to better dual-task walking compared to the SMT.
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http://dx.doi.org/10.3390/jcm8122177DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6947084PMC
December 2019

Unmet needs influence health-related quality of life in people with multiple sclerosis.

Mult Scler Relat Disord 2020 Feb 29;38:101877. Epub 2019 Nov 29.

Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), Genoa, Italy.

Background: People with MS are a heterogeneous population with varying difficulties and needs that are influenced by the individual experience of the disease, symptoms and disease course. The aim of the present study was to identify factors that influence health-related quality of life in a sample of subjects with MS, specifically health and social care-related needs and demographic and disease characteristics.

Methods: Individuals with a definite diagnosis of MS were identified through MS out-patient clinics and local branches of the Italian MS Society. The EQ-5D-3L utility index was used to describe health profiles and as an overall measure of perceived HRQoL. The number of unmet health and social care-related needs was used to describe the impact of unmet needs on HRQoL. Multiple regression analyses were performed using a hierarchical approach.

Results: Data was analyzed from 1013 subjects. Overall, 83% of subjects reported at least one health or social care-related need as being unmet and subjects with a higher number of unmet needs had lower HRQoL (p < 0.001). The number of unmet needs was entered at the first step with a statistically significant effect (Cox-Snell R 0.15, BIC 870.9, AIC 851.2). Clinical variables, included in the second step, contributed significantly to explaining the variability between models (Cox-Snell R 0.43, BIC 481.0, AIC 446.6), and the addition of socio-demographic factors further accounted for variability (Cox-Snell R, 0.46, BIC 461.0, AIC 402.0).

Conclusions: The study demonstrated that a higher number of both health and social care-related unmet needs predicted lower HRQoL. The health profile of the sample identified all domains of the EQ-5D-3L as being important in determining HRQoL. Data confirms that unmet needs alone are significantly related to reduced HRQoL, although the multifactorial and complex nature of MS makes it a challenge to identify the combination of aspects that fully predict variability in quality of life.
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http://dx.doi.org/10.1016/j.msard.2019.101877DOI Listing
February 2020

The hidden information in patient-reported outcomes and clinician-assessed outcomes: multiple sclerosis as a proof of concept of a machine learning approach.

Neurol Sci 2020 Feb 28;41(2):459-462. Epub 2019 Oct 28.

Department of Research, Italian Multiple Sclerosis Foundation, Genoa, Italy.

Machine learning (ML) applied to patient-reported (PROs) and clinical-assessed outcomes (CAOs) could favour a more predictive and personalized medicine. Our aim was to confirm the important role of applying ML to PROs and CAOs of people with relapsing-remitting (RR) and secondary progressive (SP) form of multiple sclerosis (MS), to promptly identifying information useful to predict disease progression. For our analysis, a dataset of 3398 evaluations from 810 persons with MS (PwMS) was adopted. Three steps were provided: course classification; extraction of the most relevant predictors at the next time point; prediction if the patient will experience the transition from RR to SP at the next time point. The Current Course Assignment (CCA) step correctly assigned the current MS course with an accuracy of about 86.0%. The MS course at the next time point can be predicted using the predictors selected in CCA. PROs/CAOs Evolution Prediction (PEP) followed by Future Course Assignment (FCA) was able to foresee the course at the next time point with an accuracy of 82.6%. Our results suggest that PROs and CAOs could help the clinician decision-making in their practice.
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http://dx.doi.org/10.1007/s10072-019-04093-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7005074PMC
February 2020

Conversion to Secondary Progressive Multiple Sclerosis: Patient Awareness and Needs. Results From an Online Survey in Italy and Germany.

Front Neurol 2019 22;10:916. Epub 2019 Aug 22.

IRCCS Neuromed, Pozzilli, Italy.

Few studies have investigated the experiences of patients around the conversion to secondary progressive multiple sclerosis (SPMS). ManTra is a mixed-method, co-production research project conducted in Italy and Germany to develop an intervention for newly-diagnosed SPMS patients. In previous project actions, we identified the needs and experiences of patients converting to SPMS via literature review and qualitative research which involved key stakeholders. The online patient survey aimed to assess, on a larger and independent sample of recently-diagnosed SPMS patients: (a) the characteristics associated to patient awareness of SPMS conversion; (b) the experience of conversion; (c) importance and prioritization of the needs previously identified. Participants were consenting adults with SPMS since ≤5 years. The survey consisted of three sections: on general and clinical characteristics; on experience of SPMS diagnosis disclosure (aware participants only); and on importance and prioritization of 33 pre-specified needs. Of 215 participants, those aware of their SPMS diagnosis were 57% in Italy vs. 77% in Germany ( = 0.004). In both countries, over 80% of aware participants received a SPMS diagnosis from the neurologist; satisfaction with SPMS disclosure was moderate to high. Nevertheless, 28-35% obtained second opinions, and 48-56% reported they did not receive any information on SPMS. Participants actively seeking further information were 63% in Germany vs. 31% in Italy ( < 0.001). Variables independently associated to patient awareness were geographic area (odds ratio, OR 0.32, 95% CI 0.13-0.78 for Central Italy; OR 0.21, 95% CI 0.08-0.58 for Southern Italy [vs. Germany]) and activity limitations (OR 7.80, 95% CI 1.47-41.37 for dependent vs. autonomous patients). All pre-specified needs were scored a lot or extremely important, and two prioritized needs were shared by Italian and German patients: "physiotherapy" and "active patient care involvement." The other two differed across countries: "an individualized health care plan" and "information on social rights and policies" in Italy, and "psychological support" and "cognitive rehabilitation" in Germany. Around 40% of SPMS patients were not aware of their disease form indicating a need to improve patient-physician communication. Physiotherapy and active patient care involvement were prioritized in both countries.
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http://dx.doi.org/10.3389/fneur.2019.00916DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6713887PMC
August 2019

Beyond center-based testing: Understanding and improving functioning with wearable technology in MS.

Mult Scler 2019 09;25(10):1402-1411

Scientific Research Area, Italian Multiple Sclerosis Foundation, Genoa, Italy.

Wearable sensors are designed to be worn on the body or embedded into portable devices (e.g. smartphones and smartwatches), allowing continuous patient-based monitoring, objective outcomes measuring, and feedback delivering on daily-life activities. Within the medicine domain, there has been a rapid increase in the development, testing, and use of wearable technologies especially in the context of neurological diseases. Although wearables represent promising tools also in multiple sclerosis (MS), the research on their application in MS is still ongoing, and further studies are required to assess their reliability and accuracy to monitor body functions and disability in people with MS (pwMS). Here, we provided a comprehensive overview of the opportunities, potential challenges, and limitations of the wearable technology use in MS. In particular, we classified previous findings within this field into macro-categories, considered crucial for disease management: assessment, monitoring, intervention, advice, and education. Given the increasing pivotal role played by wearables, current literature suggests that for pwMS, the time is right to shift from a center-based traditional therapeutic paradigm toward a personalized patient-based disease self-management. On this way, we present two ongoing initiatives aimed at implementing a continuous monitoring of pwMS and, consequently, providing timely and appropriate care interventions.
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http://dx.doi.org/10.1177/1352458519857075DOI Listing
September 2019

Upper limb motor training based on task-oriented exercises induces functional brain reorganization in patients with multiple sclerosis.

Neuroscience 2019 07 11;410:150-159. Epub 2019 May 11.

Department of Experimental Medicine, Section of Human Physiology, University of Genoa, Genoa, Italy. Electronic address:

The aim of this work was to investigate changes in motor performance and in the brain activation pattern during finger movements, following upper limb motor training in multiple sclerosis. Thirty people with multiple sclerosis with mild upper limb sensorimotor deficits were randomly allocated to one of two groups: the experimental group (n = 15) received an upper limb treatment based on voluntary task-oriented movements; the control group (n = 15) underwent passive mobilization of shoulder, elbow, wrist and fingers. All participants completed three treatment sessions per week for eight weeks. Before and after the intervention, all participants were evaluated for motor performance by means of Action Research Arm Test, Nine Hole Peg Test, and grip strength by a dynamometer, and for brain activations by functional magnetic resonance imaging during right finger opposition movements. Similar effects on motor performance were found in the two groups. A significant improvement with time was found in both groups at NHPT and in GRIP strength; a similar trend was found at ARAT. However, only the experimental group showed increased lateralization towards more normal brain activation following treatment, with activation clusters mainly located in the left brain hemisphere and right cerebellum. In conclusion, both active and passive interventions were effective in improving motor performance. However, only the treatment based on voluntary task-oriented movements could induce changes in brain activity that may have reflected skill acquisition by the right hand, reducing the activation of compensatory areas and decreasing brain resource demand.
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http://dx.doi.org/10.1016/j.neuroscience.2019.05.004DOI Listing
July 2019

Disparity between perceived needs and service provision: a cross-sectional study of Italians with multiple sclerosis.

Neurol Sci 2019 Jun 27;40(6):1137-1144. Epub 2019 Feb 27.

Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), via Operai 40, 16149, Genoa, Italy.

Background: Assessing the coverage by public or private resources in meeting health-related and social-related needs may be useful for service planning and guide optimization of care, important especially in view of an increase in the prevalence of multiple sclerosis (MS).

Methods: An ad hoc questionnaire assessed satisfaction of health-related and social care-related needs in a cross-sectional study of 1014 people with MS identified through MS outpatient clinics and local branches and social media channels of the Italian MS Society.

Results: 87.1% and 79.8% of the responders had experienced at least one health-related or social-related need, respectively. The study demonstrated significant gaps between perceived needs and service provision. Rehabilitation, residential care, and psychological support were most frequently unsatisfied health-related needs, while the more commonly unmet social-related needs were financial support, elimination of architectural barriers, workplace adaptations, and career guidance. The multivariate analysis highlighted that the satisfaction of health-related needs was primarily associated with geographic area of residence. Social-related needs correlated with both clinical and sociodemographic aspects.

Conclusion: The results provide insight into the range of interventions, care, and support people with MS report to be important to them at different points in their disease trajectory. More emphasis should be put on the inequitable distribution of NHS services in different geographic areas of Italy as well as on particularly fragile subgroups of the MS population (older individuals, and those with higher levels of disability) because the care of these individuals continues to be assumed by the family.
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http://dx.doi.org/10.1007/s10072-019-03780-zDOI Listing
June 2019

Clinical correlates of 9-hole peg test in a large population of people with multiple sclerosis.

Mult Scler Relat Disord 2019 May 28;30:1-8. Epub 2019 Jan 28.

Dept. of Neurosciences, S. Camillo-Forlanini Hospital, c.ne Gianicolense 87, 00152 Rome, Italy.

Objective: To assess the distribution of nine hole peg test (9-HPT) and its clinical correlates in a large sample of patients with multiple sclerosis (MS).

Methods: Data was collected in a multi-centre, cross-sectional study involving 4 Italians MS centres. We collected demographic and clinical data of 363 patients (244 women, 199 men), including year of symptom onset, disease course, Expanded Disability Status Scale (EDSS).

Results: A total of 206 (61.3%) patients scored ≥2 standard deviations (SDs) of normative values in both hands, while only 38 (11.3%) scored <1 SD from normative values at 9-HPT. We found ceiling and floor effects in mildly (EDSS < 3.0) and severely (EDSS > 6.0) impaired patients. Patients with a primary progressive disease course and those with a more severe disability level showed the large between-hand asymmetry. In multivariate models, predictors of unimanual and bimanual impairments were primary progressive course (odds ratio [OR] = 7.27, p = 0.001) and higher EDSS score (OR = 2.13 for each step, p < 0.001), respectively.

Conclusion: We suggest that 9-HPT should be used with caution in patients with low or high disability levels. Between-hand asymmetry and stratification for age, disease course, and presence/absence of bilateral involvement should be taken into account for future study design.
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http://dx.doi.org/10.1016/j.msard.2019.01.043DOI Listing
May 2019

Brain activity pattern changes after adaptive working memory training in multiple sclerosis.

Brain Imaging Behav 2020 Feb;14(1):142-154

Department of Experimental Medicine, Section of Human Physiology, University of Genoa, Viale Benedetto XV 3, 16132, Genoa, Italy.

Cognitive impairment and related abnormal brain activity are common in people with multiple sclerosis (PwMS). Adaptive training based on working memory (WM) has been shown to ameliorate cognitive symptoms, although the effects at a neural level are unclear. The aim of this study was to expand the existing research on the effects of an adaptive WM rehabilitative intervention on brain functional activity in PwMS. A sample of eighteen PwMS performed an 8-week home-based cognitive rehabilitation treatment based on adaptive WM training. PwMS were assessed before and after treatment using a validated neuropsychological battery and undergoing an fMRI session while carrying out a cognitive task (i.e., Paced Visual Serial Addition Test - PVSAT). fMRI activations were compared to the activation pattern elicited by eighteen matched healthy subjects performing the same task. At baseline, we found abnormal brain activity during PVSAT in PwMS when compared to healthy subjects, with a pattern including several bilateral activation clusters. Following rehabilitation, PwMS improved cognitive performance, as evaluated by the neuropsychological battery, and showed a different activation map with clusters mainly located in the right cerebellum and in the left hemisphere. The only significant cluster in the right hemisphere was located in the inferior parietal lobule, and the BOLD signal extracted in this area significantly correlated with cognitive performance both before and after the treatment. We suggest that WM training can improve the cognitive performance and reduce the abnormal activation of PwMS by partially maintaining or even restoring brain cognitive function.
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http://dx.doi.org/10.1007/s11682-018-9984-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7007888PMC
February 2020

Responsiveness and meaningful improvement of mobility measures following MS rehabilitation.

Neurology 2018 11 17;91(20):e1880-e1892. Epub 2018 Oct 17.

From the REVAL Rehabilitation Research Center (I.B., P.F.), BIOMED Biomedical Research Institute, Faculty of Medicine & Life Sciences, Hasselt University, Belgium; Haukeland University Hospital (Norwegian MS Competence Centre and Department of Physiotherapy) (T.S.), Bergen, Norway; Department of Physical Therapy (A.K.), Sackler Faculty of Medicine, Tel-Aviv University; Multiple Sclerosis Center (A.K.), Sheba Medical Center, Tel-Hashomer, Israel; Department of Rehabilitation, Third Faculty of Medicine (K.R.), Charles University and Faculty Hospital Royal Vineyards, Prague, Czech Republic; Multiple Sclerosis Center (A.H.-M.), Hakadal AS, Norway; Department of Neurology (R.E.), Clinic for Rehabilitation Münster, Austria; Eugenia Epalza Rehabilitation Center (I.E.M.), Bilbao, Spain; Clinical Center in Belgrado (U.N.), Serbia; Italian Multiple Sclerosis Foundation (FISM) (A.T.), Scientific Research Area, Genoa, Italy; National MS Center (P.H.), Melsbroek; AZ Klina (G.A.), Campus De Mick, Rehabilitation, Brasschaat, Belgium; John Paul II Rehabilitation Centre for People with Multiple Sclerosis (G.S.), Borne Sulinowo, Poland; Neurological Rehabilitation Centre Quellenhof (K.G.), Sana AG, Germany; IRCSS Fondazione Don Carlo Gnocchi (D.C.), Milan, Italy; Rehabilitation and MS Center Overpelt (S.B.), Belgium; University of Colorado-Anschutz Medical Campus (J.H.); and Section of Sport Science (U.D.), Department Public Health, Aarhus University, Denmark.

Objective: To determine responsiveness of functional mobility measures, and provide reference values for clinically meaningful improvements, according to disability level, in persons with multiple sclerosis (pwMS) in response to physical rehabilitation.

Methods: Thirteen mobility measures (clinician- and patient-reported) were assessed before and after rehabilitation in 191 pwMS from 17 international centers (European and United States). Combined anchor- and distribution-based methods were used. A global rating of change scale, from patients' and therapists' perspective, served as external criteria when determining the area under the receiver operating characteristic curve (AUC), the minimally important change (MIC), and the smallest real change (SRC). Patients were stratified into 2 subgroups based on disability level (Expanded Disability Status Scale score ≤4 [n = 72], >4 [n = 119]).

Results: The Multiple Sclerosis Walking Scale-12, physical subscale of the Multiple Sclerosis Impact Scale-29 (especially for the mildly disabled pwMS), Rivermead Mobility Index, and 5-repetition sit-to-stand test (especially for the moderately to severely disabled pwMS) were the most sensitive measures in detecting improvements in mobility. Findings were determined once the AUC (95% confidence interval) was above 0.5, MIC was greater than SRC, and results were comparable from the patient and therapist perspective.

Conclusions: Responsiveness, clinically meaningful improvement, and real changes of frequently used mobility measures were calculated, showing great heterogeneity, and were dependent on disability level in pwMS.
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http://dx.doi.org/10.1212/WNL.0000000000006532DOI Listing
November 2018

Self-assessment reliability in multiple sclerosis: the role of socio-demographic, clinical, and quality of life aspects.

Neurol Sci 2019 Mar 5;40(3):617-620. Epub 2018 Oct 5.

Department of Research, Italian Multiple Sclerosis Foundation, Genoa, Italy.

Introduction: Several multiple sclerosis studies matching self- and physician assessment of disease course and disability show moderate and high agreement respectively. However, the role played by socio-demographic, clinical, and quality of life (QoL) factors was not much investigated. The study aims at exploring how self-/physician agreement could depend on these variables.

Materials And Methods: Participants were asked to report own disease course and disability according to preset categories. Kappa-value and confidence interval (CI) for disease course and two-way random interclass correlation coefficient (ICC) and CI for disability were calculated to evaluate self-/physician agreement. Χ was applied to examine whether other factors (gender, age, education, civil status, disease duration, fatigue, quality of life) had systematic effects.

Results: Data analysis on 203 participants indicated fair agreement (Kappa-value = 0.30; 95% CI 0.23-0.38) and no dependency on the categories of each variable for disease course. Satisfactory correlation was found for disability (ICC = 0.74; 95% IC 0.67-0.80), good agreement was found for almost all variable categories, and significant differences were observed for education (better agreement for higher levels), disease duration, fatigue and QoL (better agreement for worse conditions).

Discussion: Results seem to suggest that higher education and worse clinical and QoL conditions could engage the patient in developing more disease awareness and realistic self-perception and self-evaluation.
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http://dx.doi.org/10.1007/s10072-018-3589-6DOI Listing
March 2019

Osteopathic Manipulative Therapy and Multiple Sclerosis: A Proof-of-Concept Study.

J Am Osteopath Assoc 2018 Aug;118(8):531-536

Context: Research on the effect of osteopathic manipulative therapy (OMTh; manipulative care provided by foreign-trained osteopaths) on chronic symptoms of multiple sclerosis (MS) is lacking.

Objective: To evaluate the effect of OMTh on chronic symptoms of MS.

Methods: Patients with MS who were evaluated at the neurology clinic at Genoa University in Italy were recruited for this study. Participants received 5 forty-minute MS health education sessions (control group) or 5 OMTh sessions (OMTh group). All participants completed a questionnaire that assessed their level of clinical disability, fatigue, depression, anxiety, and quality of life before the first session, 1 week after the final session, and 6 months after the final session. The Extended Disability Status Scale, a modified Fatigue Impact Scale, the Beck Depression Inventory-II, the Beck Anxiety Inventory, and the 12-item Short Form Health Survey were used to assess clinical disability, fatigue, depression, anxiety, and quality of life, respectively.

Results: Twenty-two participants were included in the study (10 in the control group and 12 in the OMTh group). In the OMTh group, statistically significant improvements in fatigue and depression were found 1 week after the final session (P=.002 and P<.001, respectively). An increase in quality of life was also found in the OMTh group 1 week after the final session (P=.36).

Conclusion: Results demonstrate that OMTh should be considered in the treatment of patients with chronic symptoms of MS.
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http://dx.doi.org/10.7556/jaoa.2018.121DOI Listing
August 2018

User testing as a method for evaluating subjects' understanding of informed consent in clinical trials in multiple sclerosis.

Mult Scler Relat Disord 2018 Oct 20;25:108-111. Epub 2018 Jul 20.

Scientific Research Area, Italian Multiple Sclerosis Foundation (FISM), Genoa, Italy.

The Patient Information Sheet (PIS) is an important aspect of the consent process in a clinical trial that provides potential participants the necessary information for deciding whether to take part in a specific study and for understanding their rights pertaining to participation. User Testing was originally developed to assess how written information about medicinal products performs with its intended users. User testing has been proposed in a small number of clinical trials and has been able to identify subjects' ability or inability to find and understand important information related to providing a valid consent to participate. A 21-item ad hoc user testing questionnaire was applied to 2 PIS used in clinical trials in MS. Sixty subjects were allocated to a group testing an observational study PIS (O-PIS) or to a group testing an intervention study PIS (I-PIS). In the O-PIS group, 19.4% of subjects located all relevant information within the text (21/21) and 3.4% of subjects in the I-PIS group. Overall, 82.1% of subjects testing the O-PIS understood the text and 53.5% of subjects testing the I-PIS understood the text. In the category 'nature and purpose of the trial', one-third of subjects did not understand the text, including the aim of the study. User testing should be considered as a valid tool in evaluating the comprehensibility of PIS in the context of clinical trials MS to assure that subjects provide a valid consent to participate.
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http://dx.doi.org/10.1016/j.msard.2018.07.034DOI Listing
October 2018

Motor Imagery as a Function of Disease Severity in Multiple Sclerosis: An fMRI Study.

Front Hum Neurosci 2017 11;11:628. Epub 2018 Jan 11.

Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, United States.

Motor imagery (MI) is defined as mental execution without any actual movement. While healthy adults usually show temporal equivalence, i.e., isochrony, between the mental simulation of an action and its actual performance, neurological disorders are associated with anisochrony. Unlike in patients with stroke and Parkinson disease, only a few studies have investigated differences of MI ability in multiple sclerosis (MS). However, the relationship among disease severity, anisochrony and brain activation patterns during MI has not been investigated yet. Here, we propose to investigate MI in MS patients using fMRI during a behavioral task executed with dominant/non-dominant hand and to evaluate whether anisochrony is associated with disease severity. Thirty-seven right-handed MS patients, 17 with clinically isolated syndrome (CIS) suggestive of MS and 20 with relapsing-remitting MS (RR-MS) and 20 right-handed healthy controls (HC) underwent fMRI during a motor task consisting in the actual or imaged movement of squeezing a foam ball with the dominant and non-dominant hand. The same tasks were performed outside the MRI room to record the number of actual and imagined ball squeezes, and calculate an Index of performance (IP) based on the ratio between actual and imagined movements. IP showed that a progressive loss of ability in simulating actions (i.e., anisochrony) more pronounced for non-dominant hand, was found as function of the disease course. Moreover, anisochrony was associated with activation of occipito-parieto-frontal areas that were more extensive at the early stages of the disease, probably in order to counteract the changes due to MS. However, the neural engagement of compensatory brain areas becomes more difficult with more challenging tasks, i.e., dominant vs. non-dominant hand, with a consequent deficit in behavioral performance. These results show a strict association between MI performance and disease severity, suggesting that, at early stages of the disease, anisochrony in MI could be considered as surrogate behavioral marker of MS severity.
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http://dx.doi.org/10.3389/fnhum.2017.00628DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5768615PMC
January 2018