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Clinical Trial
. 2024 Jan;31(1):e16055.
doi: 10.1111/ene.16055. Epub 2023 Sep 10.

Home-based exergaming to treat gait and balance disorders in patients with Parkinson's disease: A phase II randomized controlled trial

Affiliations
Clinical Trial

Home-based exergaming to treat gait and balance disorders in patients with Parkinson's disease: A phase II randomized controlled trial

Dijana Nuic et al. Eur J Neurol. 2024 Jan.

Abstract

Background: Exergaming has been proposed to improve gait and balance disorders in Parkinson's disease (PD) patients. We aimed to assess the efficacy of a home-based, tailored, exergaming training system designed for PD patients with dopa-resistant gait and/or balance disorders in a controlled randomized trial.

Methods: We recruited PD patients with dopa-resistant gait and/or balance disorders. Patients were randomly assigned (1:1 ratio) to receive 18 training sessions at home by playing a tailored exergame with full-body movements using a motion capture system (Active group), or by playing the same game with the computer's keyboard (Control group). The primary endpoint was the between-group difference in the Stand-Walk-Sit Test (SWST) duration change after training. Secondary outcomes included parkinsonian clinical scales, gait recordings, and safety.

Results: Fifty PD patients were enrolled and randomized. After training, no significant difference in SWST change was found between groups (mean change SWST duration [SD] -3.71 [18.06] s after Active versus -0.71 [3.41] s after Control training, p = 0.61). Some 32% of patients in the Active and 8% in the Control group were considered responders to the training program (e.g., SWST duration change ≥2 s, p = 0.03). The clinical severity of gait and balance disorders also significantly decreased after Active training, with a between-group difference in favor of the Active training (p = 0.0082). Home-based training induced no serious adverse events.

Conclusions: Home-based training using a tailored exergame can be performed safely by PD patients and could improve gait and balance disorders. Future research is needed to investigate the potential of exergaming.

Keywords: Parkinson's disease; exergaming; falls; gait disorders; rehabilitation.

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Conflict of interest statement

D.N., S.v.d.W., S.C., A.S., E.Z., C.O., J.‐C.C., J.Z.P., G.M., B.L., B.R.B., N.M.d.V., and M.‐L.W. declare they have no conflict of interest relative to the research. D.N., A.S., S.v.d.W., C.O., J.Z.P., G.M., S.C., and E.Z. have no conflict of interest to declare. B.L. received research grants from the Brain Institute Foundation and Agence Nationale de la Recherche outside of this work. P.F. is employed by Genious Healthcare France which has no property rights on the data. J.‐C.C. received research grants from the Paris Brain Institute, France Parkinson, and Agence Nationale de la Recherche outside of this work; fees for advisory boards for Servier, Biophytis, Biogen, UCB, Prevail Therapeutics, and Alzprotect outside of this work. B.R.B. serves as the Co‐Editor in Chief for the Journal of Parkinson's Disease, serves on the editorial board of Practical Neurology and Digital Biomarkers, has received fees from serving on the scientific advisory board for UCB, Kyowa Kirin, Zambon, and the Critical Path Institute (paid to the Institute), has received fees for speaking at conferences from AbbVie, Biogen, UCB, Zambon, Roche, GE Healthcare, Oruen, Novartis, and Bial (paid to the Institute), and has received research support from the Netherlands Organisation for Health Research and Development, The Michael J. Fox Foundation, UCB, the Stichting Parkinson Fonds, Hersenstichting Nederland, de Stichting Woelse Waard, Stichting Alkemade‐Keuls, de Maag Lever Darm Stichting, Parkinson NL, Davis Phinney Foundation, the Parkinson's Foundation, Verily Life Sciences, Horizon 2020, the Topsector Life Sciences and Health, Nothing Impossible, and the Parkinson Vereniging outside the submitted work. N.M.d.V. received research grants from the Netherlands Organisation for Health Research and Development outside of this work. M.L.W. received research grants from the Paris Brain Institute, Agence Nationale de la Recherche, The Michael J. Fox Foundation, and Boston Scientific; and personal fees from Boston Scientific and Medtronic outside of this work.

Figures

FIGURE 1
FIGURE 1
Flowchart of the study design.
FIGURE 2
FIGURE 2
‘Toap Run’ exergaming and training program. (a) Top to Bottom: ‘The Garden’, ‘The Mine’, and ‘The River’. The movements are schematically represented on the right side of the images, from top to bottom: arm extension, lateral shift, trunk lateral displacement with knee flexion, knee flexion/extension, trunk rotation with arm movements, and anteroposterior trunk movement. (b) The diagram represents the changes in the duration = x‐axis‐time in minutes (from 15 min for the first session S01 to 45 min for the last session S18) and gaming environments – garden in green, mine with steps in light orange, mine with lunge movements in dark‐orange, and river in blue – for the two patient groups. The level of difficulty was also increased with time, from easy (one point) to difficult (three points), for each environment. The duration of training in each environment is shown in white numbers. The level of difficulty was defined according to the frequency of movements to be performed with three different rhythms: easy: 20 beats/min, medium: 30 beats/min, and difficult: 40 beats/min.
FIGURE 3
FIGURE 3
CONSORT (Consolidated Standards of Reporting Trials) diagram.
FIGURE 4
FIGURE 4
Training programmes and Stand‐Walk‐Sit Test (SWST) durations before and after Active or Control exergaming training at home. (a) Box plots for the duration (upper) and number of movements (bottom) performed during the home‐based exergaming training sessions and over time in patients from the Active (pink) and Control (blue) groups, during the 6‐week randomized period from the first (S01) to the last training session (S18). (b) Box plots for the SWST duration at baseline and after 6 weeks of training (post‐training) in patients from the Active (pink) and Control (blue) groups, with a base‐10 logarithmic scale. Each dot represents one individual patient.

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