Home-based serious-game rehabilitation for walking and balance in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, randomized controlled study will enroll 80 patients with Parkinson's disease and gait or balance disorders across four French expert centers, randomizing 40 to home-based rehabilitation using the TOAP RUN serious game with Kinect plus usual care and 40 to usual care alone for 12 months. Intervention participants will complete 2–3 guided sessions per week at home and costs and outcomes will be measured at baseline, 6 and 12 months. The primary outcome is a medico-economic endpoint: the difference in incremental cost-utility ratio between groups at 12 months, while secondary outcomes include clinical and neurophysiological measures of gait, balance, cognition, emotional state, and an imaging substudy at the Paris site. The trial is open-label and both groups will be free to use serious games after the intervention period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's disease (according to United Kingdom Parkinson's Disease Society Brain Bank \[UKPDD\] criteria) ;
2. Age ≥ 18 years ;
3. Patient with gait and/or balance disorders not improved by levodopa treatment with item 12 "walking and balance" ≥ 1 of the MDS-UPDRS (Movement-Disorders Society-Unified Parkinson's disease rating scale) part II, ON levodopa and/or item 13 of "gait freezing" ≥ 1 (Goetz, Tilley et al. 2008);
4. Number of falls ≥ 2 in the previous year;
5. Stable antiparkinsonian treatments for at least 1 month prior to inclusion in the study ;
6. Patient with social health insurance ;
7. Person who voluntarily and informedly agreed to participate in the study (signed written consent) ;
8. Other medical problems that are stable or do not interfere with the proposed protocol;

Exclusion Criteria:

1. Parkinson's disease with Hoehn\&Yahr stage 5 corresponding to an inability of the subject to stand or walk alone ;
2. Dementia (MMS \< 24 and/or MoCA \< 18) ;
3. Presence of an impulse control disorder defined by item 6 of the MDS-UPDRS part I \> 2 ;
4. Absence of internet connection at home ;
5. Serious pathology interfering with the test ;
6. Estimated life expectancy of less than 2 years ;
7. Subject in a period of exclusion from further research ;
8. Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights and liberty ;
9. Pregnant woman or woman of childbearing age without contraceptive methods;

Where it's running

• Chu Bordeaux
  Bordeaux, France Recruiting
• Chu Lille
  Lille, France Recruiting
• Gh Pitie Salpetriere
  Paris, France Recruiting
• Rouen University Hospital
  Rouen, France Recruiting

Study contacts

• Principal investigator: Marie-Laure WELTER, Professor — Rouen Uiniversity Hospital
• Study coordinator: Nell Marty
• Email: Nell.Marty@chu-rouen.fr
• Phone: (33) 02 32 88 82 65

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.