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

Medico-economic Evaluation Rehabilitation by Serious Games at Home for the Management of Patients With Parkinson's Disease Suffering From Gait and Balance Disorders

This trial will test whether adding a home-based serious game (TOAP RUN) using Kinect for 2–3 sessions per week to usual care helps people with Parkinson's disease who have gait and balance problems over 12 months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Rouen (Academic / other)
• Locations: 4 sites (Bordeaux and 3 other locations)
• Trial ID: NCT04720365 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with idiopathic Parkinson's disease who have gait or balance problems not improved by levodopa, at least two falls in the prior year, stable Parkinson medications, social health insurance, and the ability to perform home Kinect sessions and give informed consent.

Not a fit: Patients who cannot stand or walk independently (Hoehn & Yahr stage 5), who have dementia impairing participation, who cannot use the Kinect system at home, or who have unstable medical conditions are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could improve gait and balance, reduce falls, and offer a cost-effective home rehabilitation option for people with Parkinson's disease.

How similar studies have performed: Previous small trials of exergames and virtual-reality rehabilitation in Parkinson's have shown short-term improvements in balance and gait, but long-term benefits and cost-effectiveness remain uncertain.

Eligibility criteria

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 this trial is running

Bordeaux and 3 other locations

• 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

Conditions Patients With Parkinson's Disease