Publications by authors named "Alice Nieuwboer"

151 Publications

A systematic review on exercise and training-based interventions for freezing of gait in Parkinson's disease.

NPJ Parkinsons Dis 2021 Sep 10;7(1):81. Epub 2021 Sep 10.

KU Leuven, Department of Rehabilitation Sciences, Neurorehabilitation Research Group (eNRGy), Leuven, Belgium.

Freezing of gait (FOG) in Parkinson's disease (PD) causes severe patient burden despite pharmacological management. Exercise and training are therefore advocated as important adjunct therapies. In this meta-analysis, we assess the existing evidence for such interventions to reduce FOG, and further examine which type of training helps the restoration of gait function in particular. The primary meta-analysis across 41 studies and 1838 patients revealed a favorable moderate effect size (ES = -0.37) of various training modalities for reducing subjective FOG-severity (p < 0.00001), though several interventions were not directly aimed at FOG and some included non-freezers. However, exercise and training also proved beneficial in a secondary analysis on freezers only (ES = -0.32, p = 0.007). We further revealed that dedicated training aimed at reducing FOG episodes (ES = -0.24) or ameliorating the underlying correlates of FOG (ES = -0.40) was moderately effective (p < 0.01), while generic exercises were not (ES = -0.14, p = 0.12). Relevantly, no retention effects were seen after cessation of training (ES = -0.08, p = 0.36). This review thereby supports the implementation of targeted training as a treatment for FOG with the need for long-term engagement.
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http://dx.doi.org/10.1038/s41531-021-00224-4DOI Listing
September 2021

Compromised Brain Activity With Age During a Game-Like Dynamic Balance Task: Single- vs. Dual-Task Performance.

Front Aging Neurosci 2021 5;13:657308. Epub 2021 Jul 5.

Neuromotor Rehabilitation Research Group, Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.

Postural control and cognition are affected by aging. We investigated whether cognitive distraction influenced neural activity differently in young and older adults during a game-like mediolateral weight-shifting task with a personalized task load. Seventeen healthy young and 17 older adults performed a balance game, involving hitting virtual wasps, serial subtractions and a combination of both (dual-task). A motion analysis system estimated each subject's center of mass position. Cortical activity in five regions was assessed by measuring oxygenated hemoglobin (HbO) with a functional Near-Infrared Spectroscopy system. When adding cognitive load to the game, weight-shifting speed decreased irrespective of age, but older adults reduced the wasp-hits more than young adults. Accompanying these changes, older adults decreased HbO in the left pre-frontal cortex (PFC) and frontal eye fields (FEF) compared to single-tasking, a finding not seen in young adults. Additionally, lower HbO levels were found during dual-tasking compared to the summed activation of the two single tasks in all regions except for the right PFC. These relative reductions were specific for the older age group in the left premotor cortex (PMC), the right supplementary motor area (SMA), and the left FEF. Older adults showed more compromised neural activity than young adults when adding a distraction to a challenging balance game. We interpret these changes as competitive downgrading of neural activity underpinning the age-related deterioration of game performance during dual-tasking. Future work needs to ascertain if older adults can train their neural flexibility to withstand balance challenges during daily life activities.
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http://dx.doi.org/10.3389/fnagi.2021.657308DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8287632PMC
July 2021

Freezing of gait and levodopa.

Lancet Neurol 2021 07;20(7):505-506

KU Leuven, Department of Rehabilitation Sciences, Neurorehabilitation Research Group (eNRGy), Leuven 3000, Belgium.

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http://dx.doi.org/10.1016/S1474-4422(21)00175-7DOI Listing
July 2021

Cognitive-motor Interference in Individuals With a Neurologic Disorder: A Systematic Review of Neural Correlates.

Cogn Behav Neurol 2021 06 2;34(2):79-95. Epub 2021 Jun 2.

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

Background: Performing a cognitive task and a motor task simultaneously is an everyday act that can lead to decreased performance on both tasks.

Objective: To provide insight into the neural correlates associated with cognitive-motor dual tasking in individuals with a neurologic disorder.

Method: We searched the PubMed and Web of Science databases for studies that had been published up to January 16th, 2019. Studies investigating the neural correlates of cognitive-motor dual task performance in individuals with a variety of neurologic disorders were included, independently from whether the study included healthy controls. Clinical and imaging data were abstracted for the comparison between single tasks and a dual task in the individuals with a neurologic disorder and for the comparison between the healthy controls and the individuals with a neurologic disorder.

Results: Eighteen studies met the inclusion criteria. Study populations included individuals with Parkinson disease, multiple sclerosis, mild cognitive impairment, Alzheimer disease, traumatic brain injury, and stroke. Neuroimaging types used to study the neural correlates of cognitive-motor dual tasking during upper limb or gait tasks included fMRI, functional near-infrared spectroscopy, EEG, and PET.

Conclusion: Despite large heterogeneity in study methodologies, some recurrent patterns were noted. Particularly, in neurologic patients, an already higher brain activation during single tasks was seen compared with healthy controls, perhaps compromising the patients' ability to further adapt brain activation with increasing load during dual tasking and resulting in reduced behavioral dual task performance.
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http://dx.doi.org/10.1097/WNN.0000000000000269DOI Listing
June 2021

New horizons in falls prevention and management for older adults: a global initiative.

Age Ageing 2021 Sep;50(5):1499-1507

Centre for Innovation in Medical Engineering (CIME), Faculty of Engineering, University of Malaya, Kuala Lumpur, Malaysia.

Background: falls and fall-related injuries are common in older adults, have negative effects both on quality of life and functional independence and are associated with increased morbidity, mortality and health care costs. Current clinical approaches and advice from falls guidelines vary substantially between countries and settings, warranting a standardised approach. At the first World Congress on Falls and Postural Instability in Kuala Lumpur, Malaysia, in December 2019, a worldwide task force of experts in falls in older adults, committed to achieving a global consensus on updating clinical practice guidelines for falls prevention and management by incorporating current and emerging evidence in falls research. Moreover, the importance of taking a person-centred approach and including perspectives from patients, caregivers and other stakeholders was recognised as important components of this endeavour. Finally, the need to specifically include recent developments in e-health was acknowledged, as well as the importance of addressing differences between settings and including developing countries.

Methods: a steering committee was assembled and 10 working Groups were created to provide preliminary evidence-based recommendations. A cross-cutting theme on patient's perspective was also created. In addition, a worldwide multidisciplinary group of experts and stakeholders, to review the proposed recommendations and to participate in a Delphi process to achieve consensus for the final recommendations, was brought together.

Conclusion: in this New Horizons article, the global challenges in falls prevention are depicted, the goals of the worldwide task force are summarised and the conceptual framework for development of a global falls prevention and management guideline is presented.
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http://dx.doi.org/10.1093/ageing/afab076DOI Listing
September 2021

How many gait initiation trials are necessary to reliably detect anticipatory postural adjustments and first step characteristics in healthy elderly and people with Parkinson's disease?

Gait Posture 2021 07 18;88:126-131. Epub 2021 May 18.

Department of Neurology, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany.

Background: The gait initiation (GI) process can be characterized by anticipatory postural adjustments (APAs) and first step characteristics. However, even within a constrained environment, it is unclear how many trials are necessary to obtain a reliable measurement of the GI process within one assessment.

Research Question: How many gait initiation trials are necessary to reliably detect APAs and first step characteristics in healthy elderly (HC) and people with Parkinson's disease with Freezing of Gait (PD + FOG) under single (ST) and dual task (DT) conditions and are there any potential systematic errors?

Methods: Thirty-eight PD + FOG (ON-medication) and 30 HC performed 5 trials of GI under ST and DT (auditory stroop test). APAs and first-step-outcomes were captured with IMUs placed on the lower back and on each foot. Intraclass correlation coefficients (ICCs) and the standard error of measurement (SEM) were computed to investigate reliability and mixed model analysis to find potential systematic errors. Additionally, we computed an estimation for the number of necessary trials to reach acceptable reliability (ICC = 0.75) for each outcome.

Results: ICCs varied from low reliability to excellent reliability across outcomes in PD + FOG and HC. ICCs were comparable under ST and DT for most outcomes. SEM results confirmed the ICC results. A systematic error was found for the first trial in first step ROM. Number of necessary trials varied largely across outcomes.

Significance: Within-session reliability varied across outcomes but was similar for PD + FOG and HC, and ST and DT. ML size of APA and first step ROM were most reliable, whereas APA duration and latency were least reliable. Depending on the outcome of interest, future studies should conduct multiple trials of GI to increase reliability.
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http://dx.doi.org/10.1016/j.gaitpost.2021.05.016DOI Listing
July 2021

Impaired Touchscreen Skills in Parkinson's Disease and Effects of Medication.

Mov Disord Clin Pract 2021 May 12;8(4):546-554. Epub 2021 Mar 12.

KU Leuven, Department of Rehabilitation Sciences Research Group for Neurorehabilitation (eNRGy) Leuven Belgium.

Background: Deficits in fine motor skills may impair device manipulation including touchscreens in people with Parkinson's disease (PD).

Objectives: To investigate the impact of PD and anti-parkinsonian medication on the ability to use touchscreens.

Methods: Twelve PD patients (H&Y II-III), OFF and ON medication, and 12 healthy controls (HC) performed tapping, single and multi-direction sliding tasks on a touchscreen and a mobile phone task (MPT). Task performance was compared between patients (PD-OFF, PD-ON) and HC and between medication conditions.

Results: Significant differences were found in touchscreen timing parameters, while accuracy was comparable between groups. PD-OFF needed more time than HC to perform single ( = 0.048) and multi-direction ( = 0.004) sliding tasks and to grab the dot before sliding (i.e., transition times) ( = 0.040; = 0.004). For tapping, dopaminergic medication significantly increased performance times ( = 0.046) to comparable levels as those of HC. However, for the more complex multi-direction sliding, movement times remained slower in PD than HC irrespective of medication intake ( < 0.050 during ON and OFF). The transition times for the multi-direction sliding task was also higher in PD-ON than HC ( = 0.048). Touchscreen parameters significantly correlated with MPT performance, supporting the ecological validity of the touchscreen tool.

Conclusions: PD patients show motor problems when manipulating touchscreens, even when optimally medicated. This hinders using mobile technology in daily life and has implications for developing adequate E-health applications for this group. Future work needs to establish whether touchscreen training is effective in PD.
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http://dx.doi.org/10.1002/mdc3.13179DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8088105PMC
May 2021

Detecting Sensitive Mobility Features for Parkinson's Disease Stages Via Machine Learning.

Mov Disord 2021 Sep 6;36(9):2144-2155. Epub 2021 May 6.

Laboratory for Early Markers Of Neurodegeneration (LEMON), Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Medical Center, Tel Aviv, Israel.

Background: It is not clear how specific gait measures reflect disease severity across the disease spectrum in Parkinson's disease (PD).

Objective: To identify the gait and mobility measures that are most sensitive and reflective of PD motor stages and determine the optimal sensor location in each disease stage.

Methods: Cross-sectional wearable-sensor records were collected in 332 patients with PD (Hoehn and Yahr scale I-III) and 100 age-matched healthy controls. Sensors were adhered to the participant's lower back, bilateral ankles, and wrists. Study participants walked in a ~15-meter corridor for 1 minute under two walking conditions: (1) preferred, usual walking speed and (2) walking while engaging in a cognitive task (dual-task). A subgroup (n = 303, 67% PD) also performed the Timed Up and Go test. Multiple machine-learning feature selection and classification algorithms were applied to discriminate between controls and PD and between the different PD severity stages.

Results: High discriminatory values were found between motor disease stages with mean sensitivity in the range 72%-83%, specificity 69%-80%, and area under the curve (AUC) 0.76-0.90. Measures from upper-limb sensors best discriminated controls from early PD, turning measures obtained from the trunk sensor were prominent in mid-stage PD, and stride timing and regularity were discriminative in more advanced stages.

Conclusions: Applying machine-learning to multiple, wearable-derived features reveals that different measures of gait and mobility are associated with and discriminate distinct stages of PD. These disparate feature sets can augment the objective monitoring of disease progression and may be useful for cohort selection and power analyses in clinical trials of PD. © 2021 International Parkinson and Movement Disorder Society.
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http://dx.doi.org/10.1002/mds.28631DOI Listing
September 2021

Impaired Weight-Shift Amplitude in People with Parkinson's Disease with Freezing of Gait.

J Parkinsons Dis 2021 ;11(3):1367-1380

Neuromotor Rehabilitation Research Group, Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.

Background: People with Parkinson's disease and freezing of gait (FOG; freezers) suffer from pronounced postural instability. However, the relationship between these phenomena remains unclear and has mostly been tested in paradigms requiring step generation.

Objective: To determine if freezing-related dynamic balance deficits are present during a task without stepping and determine the influence of dopaminergic medication on dynamic balance control.

Methods: Twenty-two freezers, 16 non-freezers, and 20 healthy age-matched controls performed mediolateral weight-shifts at increasing frequencies when following a visual target projected on a screen (MELBA task). The amplitude and phase shift differences between center of mass and target motion were measured. Balance scores (Mini-BESTest), 360° turning speed and the freezing ratio were also measured. Subjects with Parkinson's disease were tested ON and partial OFF (overnight withdrawal) dopaminergic medication.

Results: Freezers had comparable turning speed and balance scores to non-freezers and took more levodopa. Freezers produced hypokinetic weight-shift amplitudes throughout the MELBA task compared to non-freezers (p = 0.002), which were already present at task onset (p < 0.001). Freezers also displayed an earlier weight-shift breakdown than controls when OFF-medication (p = 0.008). Medication improved mediolateral weight-shifting in freezers and non-freezers. Freezers decreased their freezing ratio in response to medication.

Conclusion: Hypokinetic weight-shifting proved a marked postural control deficit in freezers, while balance scores and turning speed were similar to non-freezers. Both weight-shift amplitudes and the freezing ratio were responsive to medication in freezers, suggesting axial motor vigor is levodopa-responsive. Future work needs to test whether weight-shifting and freezing severity can be further ameliorated through training.
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http://dx.doi.org/10.3233/JPD-202370DOI Listing
January 2021

Thalamic morphology predicts the onset of freezing of gait in Parkinson's disease.

NPJ Parkinsons Dis 2021 Mar 2;7(1):20. Epub 2021 Mar 2.

KU Leuven, Department of Rehabilitation Sciences, Neurorehabilitation Research Group, B-3000, Leuven, Belgium.

The onset of freezing of gait (FOG) in Parkinson's disease (PD) is a critical milestone, marked by a higher risk of falls and reduced quality of life. FOG is associated with alterations in subcortical neural circuits, yet no study has assessed whether subcortical morphology can predict the onset of clinical FOG. In this prospective multimodal neuroimaging cohort study, we performed vertex-based analysis of grey matter morphology in fifty-seven individuals with PD at study entry and two years later. We also explored the behavioral correlates and resting-state functional connectivity related to these local volume differences. At study entry, we found that freezers (N = 12) and persons who developed FOG during the course of the study (converters) (N = 9) showed local inflations in bilateral thalamus in contrast to persons who did not (non-converters) (N = 36). Longitudinally, converters (N = 7) also showed local inflation in the left thalamus, as compared to non-converters (N = 36). A model including sex, daily levodopa equivalent dose, and local thalamic inflation predicted conversion with good accuracy (AUC: 0.87, sensitivity: 88.9%, specificity: 77.8%). Exploratory analyses showed that local thalamic inflations were associated with larger medial thalamic sub-nuclei volumes and better cognitive performance. Resting-state analyses further revealed that converters had stronger thalamo-cortical coupling with limbic and cognitive regions pre-conversion, with a marked reduction in coupling over the two years. Finally, validation using the PPMI cohort suggested FOG-specific non-linear evolution of thalamic local volume. These findings provide markers of, and deeper insights into conversion to FOG, which may foster earlier intervention and better mobility for persons with PD.
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http://dx.doi.org/10.1038/s41531-021-00163-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7925565PMC
March 2021

Letter to the Editor on "A Randomized, Controlled Trial of Exercise for Parkinsonian Individuals With Freezing of Gait".

Mov Disord 2020 11;35(11):2122-2123

Department of Rehabilitation Sciences, Neurorehabilitation Research Group (eNRGy), KU Leuven, Leuven, Belgium.

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http://dx.doi.org/10.1002/mds.28294DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7756703PMC
November 2020

Short-Term Effects of Single-Session Split-Belt Treadmill Training on Dual-Task Performance in Parkinson's Disease and Healthy Elderly.

Front Neurol 2020 30;11:560084. Epub 2020 Sep 30.

Neurorehabilitation Research Group, Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.

Dual-tasking is challenging for people with Parkinson's disease and freezing of gait (PD+FOG) and can exacerbate freezing episodes and falls. Split-belt treadmill training (SBT) is a novel tool to train complex gait and may improve dual-task (DT) walking and turning. To investigate the single-session effects of SBT on DT walking and DT turning performance in PD+FOG and older adults (OA), compared to regular treadmill training. Forty-five PD+FOG and 36 OA participated in a single training session (30 min). They were randomized into one of four training groups: (A) SB75-steady belt speed ratio 0.75:1; (B) SB50-steady belt speed ratio 0.5:1; (C) SBCR-changing belt speed ratios between 0.75:1 and 0.5:1; and (D) Tied-Belt (TBT). Over-ground straight-line gait and an alternating turning in place task combined with a cognitive dual-task (DT) (auditory Stroop) were assessed pre- and post-training, and the following day (retention). Constrained longitudinal data analysis was used to investigate the training effects for all participants and for PD+FOG alone. DT gait speed improved at post-training for all groups ( < 0.001). However, SBT (SB50 and SBCR) led to larger post-training improvements compared to TBT, which were still visible at retention (SB50). For mean DT turning speed and Stroop response time while walking, only SBT groups showed significant improvements at post-training or retention. DT stride length, peak DT turning speed, and Stroop performance index while walking also showed larger gains in SBT compared to TBT. Results for PD+FOG alone showed similar effects although with smaller effect sizes. A single session of SBT in PD+FOG and OA showed larger short-term effects on DT walking and turning compared to TBT. Cognitive DT performance was also improved in SBT, likely due to reduced cortical control of gait. These results illustrate the potential for SBT to improve DT during complex gait and possibly reduce fall risk in clinical and healthy populations.
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http://dx.doi.org/10.3389/fneur.2020.560084DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7554617PMC
September 2020

The Effect of One Session Split-Belt Treadmill Training on Gait Adaptation in People With Parkinson's Disease and Freezing of Gait.

Neurorehabil Neural Repair 2020 10 17;34(10):954-963. Epub 2020 Sep 17.

University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany.

Background: Freezing of gait (FOG) in Parkinson's disease (PD) is associated with gait asymmetry and switching difficulty. A split-belt treadmill may potentially address those deficits.

Objective: To investigate the immediate and retention effects of one-session split-belt treadmill training (SBT) in contrast to regular tied-belt treadmill training (TBT) on gait asymmetry and adaptation in people with PD and FOG (PD + FOG) and healthy controls (HC). Additionally, to investigate differential effects of 3 SBT protocols and compare different gait adaptation outcomes.

Methods: PD + FOG (n = 45) and HC (n = 36) were randomized to 1 of 3 SBT groups (belt speeds' ratio 0.75:1; 0.5:1 or changing ratios) or TBT group. Participants were tested at Pre, Post, and Retention after one treadmill training session. Gait asymmetry was measured during a standardized adaptation test on the split-belt treadmill.

Results: SBT proved beneficial for gait adaptation in PD + FOG and HC ( < .0001); however, HC improved more. SBT with changing ratios demonstrated significant effects on gait adaptation from Pre to Post in PD + FOG, supported by strong effect sizes ( = 1.14) and improvements being retained for 24 hours. Mean step length asymmetry during initial exposure was lower in HC compared with PD + FOG ( = .035) and differentiated best between the groups.

Conclusions: PD + FOG improved gait adaptation after a single SBT session although effects were smaller than in HC. SBT with changing ratios was the most effective to ameliorate gait adaptation in PD + FOG. These promising results warrant future study on whether long-term SBT strengthens adaptation in PD + FOG and has potential to induce a better resilience to FOG. Clinical trial ID: NCT03725215.
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http://dx.doi.org/10.1177/1545968320953144DOI Listing
October 2020

Barriers and Motivators to Engage in Exercise for Persons with Parkinson's Disease.

J Parkinsons Dis 2020 ;10(4):1293-1299

Department of Neurology, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Center of Expertise for Parkinson & Movement Disorders, Nijmegen, The Netherlands.

Exercise is increasingly being recognized as a key element in the overall management of persons living with Parkinson's disease (PD) but various (disease-specific) barriers may impede even motivated patients to participate in regular exercise. We aimed to provide a comprehensive review of the various barriers and motivators for exercise in persons with PD. We scrutinized data on compliance-related factors published in cross-sectional studies, randomized controlled trials and reviews. We classified the barriers and motivators to exercise from a patient perspective according to the International Classification of Functioning, Disability and Health. We present an overview of the large range of potential motivators and barriers for exercise in persons with PD. Healthcare professionals should consider a wide and comprehensive range of factors, in order to identify which specific determinants matter most for each individual. Only when persons with PD are adequately motivated in a way that appeals to them and after all person-specific barriers have been tackled, we can begin to expect their long-term adherence to exercise. Such long-term compliance will be essential if exercise is to live up to its expectations, including the hope that prolonged engagement in regular exercise might help to modify the otherwise relentlessly progressive course of PD.
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http://dx.doi.org/10.3233/JPD-202247DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7739964PMC
September 2021

Behavioural manifestations and associated non-motor features of freezing of gait: A narrative review and theoretical framework.

Neurosci Biobehav Rev 2020 09 27;116:350-364. Epub 2020 Jun 27.

Department of Rehabilitation Science, University of Leuven, Leuven, Belgium.

Over the past decade, non-motor related symptoms and provocative contexts have offered unique opportunities to gain insight into the potential mechanisms that may underpin freezing of gait (FOG) in Parkinson's disease (PD). While this large body of work has informed several theoretical models, to date, few are capable of explaining behavioural findings across multiple domains (i.e. cognitive, sensory-perceptual and affective) and in different behavorial contexts. As such, the exact nature of these interrelationships and their neural basis remain quite enigmatic. Here, the non-motor, behavioural evidence for cognitive, sensory-perceptual and affective contributors to FOG are reviewed and synthesized by systematically examining (i) studies that manipulated contextual environments that provoke freezing of gait, (ii) studies that uncovered factors that have been proposed to contribute to freezing, and (iii) studies that longitudinally tracked factors that predict the future development of freezing of gait. After consolidating the evidence, we offer a novel perspective for integrating these multi-faceted behavioural patterns and identify key challenges that warrant consideration in future work.
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http://dx.doi.org/10.1016/j.neubiorev.2020.06.026DOI Listing
September 2020

Virtual reality in research and rehabilitation of gait and balance in Parkinson disease.

Nat Rev Neurol 2020 Aug 26;16(8):409-425. Epub 2020 Jun 26.

Research Group for Neurorehabilitation (eNRGy), Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.

Virtual reality (VR) technology has emerged as a promising tool for studying and rehabilitating gait and balance impairments in people with Parkinson disease (PD) as it allows users to be engaged in an enriched and highly individualized complex environment. This Review examines the rationale and evidence for using VR in the assessment and rehabilitation of people with PD, makes recommendations for future research and discusses the use of VR in the clinic. In the assessment of people with PD, VR has been used to manipulate environments to enhance study of the behavioural and neural underpinnings of gait and balance, improving understanding of the motor-cognitive neural circuitry involved. Despite suggestions that VR can provide rehabilitation that is more effective and less labour intensive than non-VR rehabilitation, little evidence exists to date to support these claims. Nevertheless, much unrealized potential exists for the use of VR to provide personalized assessment and rehabilitation that optimizes motor learning in both the clinic and home environments and adapts to changes in individuals over time. Design of such systems will require collaboration between all stakeholders to maximize useability, engagement, safety and effectiveness.
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http://dx.doi.org/10.1038/s41582-020-0370-2DOI Listing
August 2020

Participant expectations and experiences of a tailored physiotherapy intervention for people with Parkinson's and a history of falls.

Disabil Rehabil 2020 Jun 23:1-9. Epub 2020 Jun 23.

Biomedical Research Centre, University of Southampton, Southampton, UK.

People with Parkinson's are twice as likely to fall as older people within the general population. This longitudinal qualitative study was part of a larger programme of research including a randomised controlled trial to test the effectiveness of a tailored physiotherapy intervention. Specific qualitative aims focused on a subsample of trial participants in the intervention arm of the trial, and comprised the following:To explore the expectations of participants about the intervention.To investigate participants' experiences of the intervention, and its perceived impacts.To understand the facilitators and barriers to engagement. Two semi-structured interviews were completed with a theoretical sample of people with Parkinson's from the intervention arm, initially after randomisation but before the intervention commenced, and then again six months later. Forty-two participants out of a large clinical trial were interviewed initially, with 37 agreeing to a second interview at six months. Prior experience of rehabilitation plus information accessed through the trial consent procedure informed participants' realistic expectations. Most found the level of the intervention acceptable, and perceived a range of benefits. However, views about equipment provided were more equivocal. The biggest barriers to participation were time and motivation, whilst social support facilitated engagement with the intervention. This study is the first to capture expectations about participation in a programme of exercises and strategies. It highlights that previous challenges to engagement in physical exercises and activities are not a barrier to future participation and provides new insights into the role of equipment and technology in programmes of physical activity for people with Parkinson's. The challenge of ensuring that programmes of exercise and strategies become an embedded feature of everyday life is highlighted, particularly alongside busy social engagements and leisure pursuits.Implications for rehabilitationFor people with Parkinsons, a programme of exercises and strategies has the potential to reduce the risk of falls amongst those with a history of falling.Adherence to such programmes can prove challenging for a variety of reasons, even when participants have realistic expectations about the commitment and effort needed.Clear explanations about the role of equipment and technology within such programmes could enhance adherence.In order to further individualise programmes of exercise for people with Parkinsons, choice regarding social support, reminders and integration into everyday activities should be explored.
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http://dx.doi.org/10.1080/09638288.2020.1779824DOI Listing
June 2020

A data-driven approach for detecting gait events during turning in people with Parkinson's disease and freezing of gait.

Gait Posture 2020 07 23;80:130-136. Epub 2020 May 23.

eMedia Research Lab/STADIUS, Department of Electrical Engineering (ESAT), KU Leuven, Andreas Vesaliusstraat 13, 3000 Leuven, Belgium.

Background: Manual annotation of initial contact (IC) and end contact (EC) is a time consuming process. There are currently no robust techniques available to automate this process for Parkinson's disease (PD) patients with freezing of gait (FOG).

Objective: To determine the validity of a data-driven approach for automated gait event detection.

Methods: 15 freezers were asked to complete several straight-line and 360 degree turning trials in a 3D gait laboratory during the off-period of their medication cycle. Trials that contained a freezing episode were indicated as freezing trials (FOG) and trials without a freezing episode were termed as functional gait (FG). Furthermore, the highly varied gait data between onset and termination of a FOG episode was excluded. A Temporal Convolutional Neural network (TCN) was trained end-to-end with lower extremity kinematics. A Bland-Altman analysis was performed to evaluate the agreement between the results of the proposed model and the manual annotations.

Results: For FOG-trials, F1 scores of 0.995 and 0.992 were obtained for IC and EC, respectively. For FG-trials, F1 scores of 0.997 and 0.999 were obtained for IC and EC, respectively. The Bland-Altman plots indicated excellent timing agreement, with on average 39% and 47% of the model predictions occurring within 10 ms from the manual annotations for FOG-trials and FG-trials, respectively.

Significance: These results indicate that our data-driven approach for detecting gait events in PD patients with FOG is sufficiently accurate and reliable for clinical applications.
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http://dx.doi.org/10.1016/j.gaitpost.2020.05.026DOI Listing
July 2020

Functional neuroimaging of human postural control: A systematic review with meta-analysis.

Neurosci Biobehav Rev 2020 08 11;115:351-362. Epub 2020 May 11.

Neuromotor Rehabilitation Research Group, Department of Rehabilitation Sciences, KU Leuven, Tervuursevest 101, Bus 1501, 3001, Leuven, Belgium. Electronic address:

Postural instability is a strong risk factor for falls that becomes more prominent with aging. To facilitate treatment and prevention of falls in an aging society, a thorough understanding of the neural networks underlying postural control is warranted. Here, we present a systematic review of the functional neuroimaging literature of studies measuring posture-related neural activity in healthy subjects. Study methods were overall heterogeneous. Eleven out of the 14 studies relied on postural simulation in a supine position (e.g. motor imagery). The key nodes of human postural control involved the brainstem, cerebellum, basal ganglia, thalamus and several cortical regions. An activation likelihood estimation meta-analysis revealed that the anterior cerebellum was consistently activated across the wide range of postural tasks. The cerebellum is known to modulate the brainstem nuclei involved in the control of posture. Hence, this systematic review with meta-analysis provides insight into the neural correlates which underpin human postural control and which may serve as a reference for future neural network and region of interest analyses.
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http://dx.doi.org/10.1016/j.neubiorev.2020.04.028DOI Listing
August 2020

Do Patients With Parkinson's Disease With Freezing of Gait Respond Differently Than Those Without to Treadmill Training Augmented by Virtual Reality?

Neurorehabil Neural Repair 2020 05 23;34(5):440-449. Epub 2020 Mar 23.

KU Leuven, Leuven, Belgium.

. People with Parkinson's disease and freezing of gait (FOG+) have more falls, postural instability and cognitive impairment compared with FOG-. . To conduct a secondary analysis of the V-TIME study, a randomized, controlled investigation showing a greater reduction of falls after virtual reality treadmill training (TT + VR) compared with usual treadmill walking (TT) in a mixed population of fallers. We addressed whether these treadmill interventions led to similar gains in FOG+ as in FOG-. . A total of 77 FOG+ and 44 FOG- were assigned randomly to TT + VR or TT. Participants were assessed pre- and posttraining and at 6 months' follow-up. Main outcome was postural stability assessed by the Mini Balance Evaluation System Test (Mini-BEST) test. Falls were documented using diaries. Other outcomes included the New Freezing of Gait Questionnaire (NFOG-Q) and the Trail Making Test (TMT-B). . Mini-BEST scores and the TMT-B improved in both groups after training ( = .001), irrespective of study arm and FOG subgroup. However, gains were not retained at 6 months. Both FOG+ and FOG- had a greater reduction of falls after TT + VR compared with TT ( = .008). NFOG-Q scores did not change after both training modes in the FOG+ group. . Treadmill walking (with or without VR) improved postural instability in both FOG+ and FOG-, while controlling for disease severity differences. As found previously, TT + VR reduced falls more than TT alone, even among those with FOG. Interestingly, FOG itself was not helped by training, suggesting that although postural instability, falls and FOG are related, they may be controlled by different mechanisms.
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http://dx.doi.org/10.1177/1545968320912756DOI Listing
May 2020

Tossing and Turning in Bed: Nocturnal Movements in Parkinson's Disease.

Mov Disord 2020 06 20;35(6):959-968. Epub 2020 Feb 20.

Laboratory for Early Markers of Neurodegeneration, Center for the Study of Movement, Cognition and Mobility, Neurological Institute, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.

Background: Sleep disturbances and nocturnal hypokinesia are common in Parkinson's disease (PD). Recent work using wearable technologies showed fewer nocturnal movements in PD when compared with controls. However, it is unclear how these manifest across the disease spectrum.

Objectives: We assessed the prevalence of sleep disturbances and nocturnal hypokinesia in early and advanced PD and their relation to nonmotor symptoms and dopaminergic medication.

Methods: A total of 305 patients with PD with diverse disease severity (Hoehn and Yahr [H&Y] stage 1 = 47, H&Y stage 2 = 181, H&Y stage 3 = 77) and 205 healthy controls continuously wore a tri-axial accelerometer on the lower back for at least 2 days. Lying, turning, and upright -time at night were extracted from the acceleration signals. Percent upright time and nighttime walking were classified as sleep interruptions. The number, velocity, time, side, and degree of rotations in bed were used to evaluate nocturnal movements.

Results: Nocturnal lying time was similar among all groups (healthy controls, 7.5 ± 1.2 hours; H&Y stage 1, 7.3 ± 0.9 hours; H&Y stage 2, 7.2 ± 1.3 hours; H&Y stage 3, 7.4 ± 1.6 hours; P = 0.501). However, patients with advanced PD had more upright periods, whereas the number and velocity of their turns were reduced (P ≤ 0.021). Recently diagnosed patients (<1 year from diagnosis) were similar to controls in the number of nocturnal turns (P = 0.148), but showed longer turning time (P = 0.001) and reduced turn magnitude (P = 0.002). Reduced nocturnal movements were associated with increased PD motor severity and worse dysautonomia and cognition and with dopaminergic medication.

Conclusions: Using wearable sensors for continuous monitoring of movement at night may offer an unbiased measure of disease severity that could enhance optimal nighttime dopaminergic treatment and utilization of turning strategies. © 2020 International Parkinson and Movement Disorder Society.
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http://dx.doi.org/10.1002/mds.28006DOI Listing
June 2020

The New Freezing of Gait Questionnaire: Unsuitable as an Outcome in Clinical Trials?

Mov Disord Clin Pract 2020 Feb 14;7(2):199-205. Epub 2020 Jan 14.

KU Leuven, Department of Rehabilitation Sciences, Neurorehabilitation Research Group Leuven Belgium.

Background: Freezing of gait (FOG) is a common gait deficit in Parkinson's disease. The New Freezing of Gait Questionnaire (NFOG-Q) is a widely used and valid tool to quantify freezing of gait severity. However, its test-retest reliability and minimal detectable change remain unknown.

Objective: To determine the test-retest reliability and responsiveness of the NFOG-Q.

Methods: Two groups of freezers, involved in 2 previous rehabilitation trials, completed the NFOG-Q at 2 time points (T1 and T2), separated by a 6-week control period without active intervention. Sample 1 (N = 57) was measured in ON and sample 2 (N = 14) in OFF. We calculated various reliability statistics for the NFOG-Q scores between T1 and T2 as well as correlation coefficients with clinical descriptors to explain the variability between time points.

Results: In sample 1 the NFOG-Q showed modest reliability (intraclass correlation coefficient = 0.68 [0.52-0.80]) without differences between T1 and T2. However, a minimal detectable change of 9.95 (7.90-12.27) points emerged for the total score (range 28 points, relative minimal detectable change of 35.5%). Sample 2 showed largely similar results. We found no associations between cognitive-related or disease severity-related outcomes and variability in NFOG-Q scores.

Conclusions: We conclude that the NFOG-Q is insufficiently reliable or responsive to detect small effect sizes, as changes need to go beyond 35% to surpass measurement error. Therefore, we warrant caution in using the NFOG-Q as a primary outcome in clinical trials. These results emphasize the need for robust and objective freezing of gait outcome measures.
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http://dx.doi.org/10.1002/mdc3.12893DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7011794PMC
February 2020

Repetitive Motor Control Deficits Most Consistent Predictors of Conversion to Freezing of Gait in Parkinson's Disease: A Prospective Cohort Study.

J Parkinsons Dis 2020 ;10(2):559-571

KU Leuven, Department of Rehabilitation Sciences, Neurorehabilitation Research Group, Leuven, Belgium.

Background: The onset of freezing of gait (FOG) represents a turning point in the lives of patients with Parkinson's disease (PD). FOG increases fall risk and is associated with worse physical and mental health related quality of life, thus increasing disease burden. Moreover, therapeutic studies aiming to ameliorate freezing have had limited success. In a step towards pre-emptive therapy to delay or prevent the onset of FOG, this prospective cohort study set out to uncover clinical markers of conversion to FOG.

Objective: Investigate clinical markers of conversion to FOG.

Methods: Sixty PD patients without FOG were followed up for two years and underwent extensive clinical testing each year. FOG classification was made with the New Freezing of Gait Questionnaire. Clinical predictors of conversion to FOG were investigated using univariate analysis and through building a multivariable model using all measured components.

Results: Twelve patients developed FOG during the study (Incidence: 11.5% per year). Due to the large number of predictors, univariate analyses did not survive multiple comparison correction, precluding strong inference on any one predictor. Overall, the effect sizes suggested that motor deficits including difficulties with repetitive movement scaling (AUC: 0.71), coordination (AUC: 0.73) and consistency (AUC: 0.76) as well as gait asymmetry (AUC: 0.79) and variability (AUC: 0.71) were most predictive of conversion. Further, converters reported more subjective cognitive difficulty (AUC: 0.74), although their measured performance was similar to non-converters. Multivariable analyses further showed that the two components most consistently selected in the predictive model were: 1) an MDS-UPDRS component with worse axial motor, hand use and non-motor symptoms; and 2) finger tapping abnormalities.

Conclusion: Conversion to FOG was predicted mainly by objective and clinical measures of motor dyscontrol, as non-motor disturbances were surfacing. Although based on a small cohort with limited converters, this novel finding informs future studies aimed at FOG prevention.
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http://dx.doi.org/10.3233/JPD-191759DOI Listing
July 2021

Falls Risk in Relation to Activity Exposure in High-Risk Older Adults.

J Gerontol A Biol Sci Med Sci 2020 05;75(6):1198-1205

Translational and Clinical Research Institute, Faculty of Medical Sciences, Clinical Ageing Research Unit, Campus for Ageing and Vitality, Newcastle University, Newcastle upon Tyne, UK.

Background: Physical activity is linked to many positive health outcomes, stimulating the development of exercise programs. However, many falls occur while walking and so promoting activity might paradoxically increase fall rates, causing injuries, and worse quality of life. The relationship between activity exposure and fall rates remains unclear. We investigated the relationship between walking activity (exposure to risk) and fall rates before and after an exercise program (V-TIME).

Methods: One hundred and nine older fallers, 38 fallers with mild cognitive impairment (MCI), and 128 fallers with Parkinson's disease (PD) were randomly assigned to one of two active interventions: treadmill training only or treadmill training combined with a virtual reality component. Participants were tested before and after the interventions. Free-living walking activity was characterized by volume, pattern, and variability of ambulatory bouts using an accelerometer positioned on the lower back for 1 week. To evaluate that relationship between fall risk and activity, a normalized index was determined expressing fall rates relative to activity exposure (FRA index), with higher scores indicating a higher risk of falls per steps taken.

Results: At baseline, the FRA index was higher for fallers with PD compared to those with MCI and older fallers. Walking activity did not change after the intervention for the groups but the FRA index decreased significantly for all groups (p ≤ .035).

Conclusions: This work showed that V-TIME interventions reduced falls risk without concurrent change in walking activity. We recommend using the FRA index in future fall prevention studies to better understand the nature of intervention programs.
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http://dx.doi.org/10.1093/gerona/glaa007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7243591PMC
May 2020

Premotor dorsal white matter integrity for the prediction of upper limb motor impairment after stroke.

Sci Rep 2019 12 23;9(1):19712. Epub 2019 Dec 23.

KU Leuven - University of Leuven, Department of Rehabilitation Sciences, Leuven, Belgium.

Corticospinal tract integrity after stroke has been widely investigated through the evaluation of fibres descending from the primary motor cortex. However, about half of the corticospinal tract is composed by sub-pathways descending from premotor and parietal areas, to which damage may play a more specific role in motor impairment and recovery, particularly post-stroke. Therefore, the main aim of this study was to investigate lesion load within corticospinal tract sub-pathways as predictors of upper limb motor impairment after stroke. Motor impairment (Fugl-Meyer Upper Extremity score) was evaluated in 27 participants at one week and six months after stroke, together with other clinical and demographic data. Neuroimaging data were obtained within the first week after stroke. Univariate regression analysis indicated that among all neural correlates, lesion load within premotor fibres explained the most variance in motor impairment at six months (R = 0.44, p < 0.001). Multivariable regression analysis resulted in three independent, significant variables explaining motor impairment at six months; Fugl-Meyer Upper Extremity score at one week, premotor dorsal fibre lesion load at one week, and age below or above 70 years (total R = 0.81; p < 0.001). Early examination of premotor dorsal fibre integrity may be a promising biomarker of upper limb motor impairment after stroke.
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http://dx.doi.org/10.1038/s41598-019-56334-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6928144PMC
December 2019

tDCS-Enhanced Consolidation of Writing Skills and Its Associations With Cortical Excitability in Parkinson Disease: A Pilot Study.

Neurorehabil Neural Repair 2019 12 18;33(12):1050-1060. Epub 2019 Nov 18.

KU Leuven, Leuven, Belgium.

. Learning processes of writing skills involve the re-engagement of previously established motor programs affected by Parkinson disease (PD). To counteract the known problems with consolidation in PD, transcranial direct current stimulation (tDCS) could be imperative to achieve a lasting regeneration of habitual motor skills. . To examine tDCS-enhanced learning of writing and explore alterations in cortical excitability after stimulation in PD compared with healthy controls (HCs). . Ten patients and 10 HCs received 2 training sessions combined with 20 minutes of 1-mA anodal tDCS or sham on the left primary motor cortex in a randomized crossover design. Writing skills on a tablet and paper were assessed at baseline, after training, and after 1 week of follow-up. Before and immediately after the intervention, cortical excitability and inhibition were measured during rest and activity. . Writing amplitude and velocity improved when practice was tDCS supplemented compared with sham in PD. Benefits were sustained at retention for trained and untrained tasks on the tablet as well as for writing on paper. No improvements were found for HCs. Reduced resting motor thresholds after tDCS indicated tDCS-enhanced cortical excitability. Additionally, increments in motor-evoked potential amplitudes correlated with improved writing in PD, whereas HCs showed the opposite pattern. . Our results endorse the usefulness of tDCS-boosted learning in PD, at least when applied to improving writing capacity. Although further confirmatory studies are needed, these novel findings are striking because tDCS-mediated consolidation was found for learning a motor task directly affected by PD.
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http://dx.doi.org/10.1177/1545968319887684DOI Listing
December 2019

Freezing of gait: understanding the complexity of an enigmatic phenomenon.

Brain 2020 01;143(1):14-30

Parkinson's Disease Research Clinic, Brain and Mind Centre, University of Sydney, Australia.

Diverse but complementary methodologies are required to uncover the complex determinants and pathophysiology of freezing of gait. To develop future therapeutic avenues, we need a deeper understanding of the disseminated functional-anatomic network and its temporally associated dynamic processes. In this targeted review, we will summarize the latest advances across multiple methodological domains including clinical phenomenology, neurogenetics, multimodal neuroimaging, neurophysiology, and neuromodulation. We found that (i) locomotor network vulnerability is established by structural damage, e.g. from neurodegeneration possibly as result from genetic variability, or to variable degree from brain lesions. This leads to an enhanced network susceptibility, where (ii) modulators can both increase or decrease the threshold to express freezing of gait. Consequent to a threshold decrease, (iii) neuronal integration failure of a multilevel brain network will occur and affect one or numerous nodes and projections of the multilevel network. Finally, (iv) an ultimate pathway might encounter failure of effective motor output and give rise to freezing of gait as clinical endpoint. In conclusion, we derive key questions from this review that challenge this pathophysiological view. We suggest that future research on these questions should lead to improved pathophysiological insight and enhanced therapeutic strategies.
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http://dx.doi.org/10.1093/brain/awz314DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6938035PMC
January 2020

Motor Adaptation in Parkinson's Disease During Prolonged Walking in Response to Corrective Acoustic Messages.

Front Aging Neurosci 2019 24;11:265. Epub 2019 Sep 24.

Department of Electrical, Electronic, and Information Engineering, University of Bologna, Bologna, Italy.

Wearable sensing technology is a new way to deliver corrective feedback. It is highly applicable to gait rehabilitation for persons with Parkinson's disease (PD) because feedback potentially engages spared neural function. Our study characterizes participants' motor adaptation to feedback signaling a deviation from their normal cadence during prolonged walking, providing insight into possible novel therapeutic devices for gait re-training. Twenty-eight persons with PD (15 with freezing, 13 without) and 13 age-matched healthy elderly (HE) walked for two 30-minute sessions. When their cadence varied, they heard either intelligent cueing (IntCue: bouts of ten beats indicating normal cadence) or intelligent feedback (IntFB: verbal instruction to increase or decrease cadence). We created a model that compares the effectiveness of the two conditions by quantifying the number of steps needed to return to the target cadence for every deviation. The model fits the short-term motor responses to the external step inputs (collected with wearable sensors). We found some significant difference in motor adaptation among groups and subgroups for the IntCue condition only. Both conditions were instead able to identify different types of responders among persons with PD, although showing opposite trends in their speed of adaptation. Increasing rather than decreasing the pace appeared to be more difficult for both groups. In fact, under IntFB the PD group required about seven steps to increase their cadence, whereas they only needed about three steps to decrease their cadence. However, it is important to note that this difference was not significant; perhaps future work could include more participants and/or more sessions, increasing the total number of deviations for analysis. Notably, a significant negative correlation, = -0.57 (-value = 0.008), was found between speed of adaptation and number of deviations during IntCue, but not during IntFB, suggesting that, for people who struggle with gait, such as those with PD, verbal instructions rather than metronome beats might be more effective at restoring normal cadence. Clinicians and biofeedback developers designing novel therapeutic devices could apply our findings to determine the optimal timing for corrective feedback, optimizing gait rehabilitation while minimizing the risk of cue-dependency.
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http://dx.doi.org/10.3389/fnagi.2019.00265DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6769108PMC
September 2019

Retention of touchscreen skills is compromised in Parkinson's disease.

Behav Brain Res 2020 01 27;378:112265. Epub 2019 Sep 27.

Research Group for Neurorehabilitation (eNRGy), Department of Rehabilitation Sciences, KU Leuven, Tervuursevest 101, box 1501, Leuven, Belgium; Leuven Brain Institute (LBI), KU Leuven, Leuven, Belgium. Electronic address:

Fine motor skill impairments likely have a severe impact on the use of touchscreens in Parkinson's disease (PD). Although recent work showed positive effects of intensive writing training, many questions remained regarding the consolidation of motor learning in PD. The current study examined the effects of PD on practicing the manipulation of touchscreen technology and whether this can lead to 24h-retention and transfer. We developed the Swipe-Slide Pattern (SSP)-task, similar to handling a touchscreen unlock-trace. On day 1, 11 patients and 10 healthy, age-matched controls underwent two consecutive runs of early and late learning (9 × 36 s SSP and 36 s rest). This was followed by a retention test after 24 h, including the assessment of transfer. Movement time (MT, s), Euclidean distance (ED) and a performance index (PI = MT/ED) were compared across the learning phases (early, late, retention and transfer) for both groups. Additionally, a learning, retention and transfer index were compared between groups and correlated to clinical characteristics. Both groups significantly improved in MT and PI across practice. However, while healthy adults showed further improvements after a 24h-retention period, patients presented with impaired retention indices. This was correlated with disease duration, disease severity and performance on a daily life mobile phone task. Finally, transfer to a similar, but untrained pattern was comparable between both groups. Overall, short-term practice of the SSP-task results in improvements for PD patients, albeit with impaired retention. Future work should investigate whether prolonged touchscreen skill training can be retained in motor memory in PD.
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http://dx.doi.org/10.1016/j.bbr.2019.112265DOI Listing
January 2020

Exercise- and strategy-based physiotherapy-delivered intervention for preventing repeat falls in people with Parkinson's: the PDSAFE RCT.

Health Technol Assess 2019 07;23(36):1-150

Faculty of Health Science, University of Southampton, Southampton, UK.

Background: People with Parkinson's disease are twice as likely to experience a fall as a healthy older person, often leading to debilitating effects on confidence, activity levels and quality of life.

Objective: To estimate the effect of a physiotherapy programme for fall prevention among people with Parkinson's disease.

Design: A multicentre, pragmatic, investigator-masked, individually randomised controlled trial (RCT) with prespecified subgroup analyses.

Setting: Recruitment from NHS hospitals and clinics and community and social services in eight English regions with home-based interventions.

Participants: A total of 474 people with Parkinson's disease (i.e. Hoehn and Yahr scale stages 1-4) were recruited: 238 were assigned to a physiotherapy programme and 236 were assigned to usual care. Random allocation was 50 : 50.

Interventions: All participants received routine care; the usual-care group received an information digital versatile disc (DVD) and a single advice session at trial completion. The intervention group had an individually tailored, progressive, home-based fall avoidance strategy training programme with balance and strengthening exercises: PDSAFE.

Main Outcome Measures: The primary outcome was the risk of repeat falling, collected by self-report monthly diaries between 0 and 6 months after randomisation. Secondary outcomes included near-falls, falls efficacy, freezing of gait (FoG), health-related quality of life, and measurements taken using the Mini-Balance Evaluation Systems Test (Mini-BESTest), the Chair Stand Test (CST), the Geriatric Depression Scale, the Physical Activity Scale for the Elderly and the Parkinson's Disease Questionnaire.

Results: PDSAFE is the largest RCT of falls management among people with Parkinson's disease: 541 patients were screened for eligibility. The average age was 72 years, and 266 out of 474 (56%) participants were men. Of the 474 randomised participants, 238 were randomised to the intervention group and 236 were randomised to the control group. No difference in repeat falling within 6 months of randomisation was found [PDSAFE group to control group odds ratio (OR) 1.21, 95% confidence interval (CI) 0.74 to 1.98;  = 0.447]. An analysis of secondary outcomes demonstrated better balance (Mini-BESTest: mean difference 0.95, 95% CI 0.24 to 1.67;  = 0.009), functional strength (CST:  = 0.041) and falls efficacy (Falls Efficacy Scale - International: mean difference 1.6, 95% CI -3.0 to -0.19;  = 0.026) with near-falling significantly reduced with PDSAFE (OR 0.67, 95% CI 0.53 to 0.86;  = 0.001) at 6 months. Prespecified subgroup analysis (i.e. disease severity and FoG) revealed a PDSAFE differing effect; the intervention may be of benefit for people with moderate disease but may increase falling for those in the more severe category, especially those with FoG.

Limitations: All participants were assessed at primary outcome; only 73% were assessed at 12 months owing to restricted funding.

Conclusions: PDSAFE was not effective in reducing repeat falling across the range of people with Parkinson's disease in the trial. Secondary analysis demonstrated that other functional tasks and self-efficacy improved and demonstrated differential patterns of intervention impact in accordance with disease severity and FoG, which supports previous secondary research findings and merits further primary evaluation.

Future Work: Further trials of falls prevention on targeted groups of people with Parkinson's disease are recommended.

Trial Registration: Current Controlled Trials ISRCTN48152791.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 23, No. 36. See the NIHR Journals Library website for further project information. Sarah E Lamb is funded by the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) at Oxford Health NHS Foundation Trust, the NIHR Oxford Biomedical Research Centre at the Oxford University Hospitals NHS Foundation Trust and CLAHRC Oxford. Victoria A Goodwin is supported by the NIHR Collaborations for Leadership in Applied Health Research and Care in the South West Peninsula (PenCLAHRC). Lynn Rochester is supported by the NIHR Newcastle Biomedical Research Centre based at Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University. The research was also supported by the NIHR Newcastle Clinical Research Facility Infrastructure funding. Helen C Roberts is supported by CLAHRC Wessex and the NIHR Southampton Biomedical Research Centre.
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http://dx.doi.org/10.3310/hta23360DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6680369PMC
July 2019
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