NCT04720365

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, open-label, multi-center, randomized controlled study of 80 Parkinson's disease patients with gait and balance disorders in which 40 patients will be treated with serious games, in addition to their usual care, for 12 months and 40 patients will be treated with their usual care during this period. This study will be conducted in 4 centers, all of which are expert in the management of these patients. After randomization, each patient in the "Intervention-Rehabilitation through Toap Run" group will have to complete 2 to 3 sessions per week at home with the serious game "TOAP RUN" using the Kinect® system for 1 year.

Detailed description

This is a multi-center, randomized, open-label, multi-center, randomized controlled study of 80 Parkinson's disease patients with gait and balance disorders in which 40 patients will be treated with serious games, in addition to their usual care, for 12 months and 40 patients will be treated with their usual care during this period. This study will be conducted in 4 centers, all of which are expert in the management of these patients. After randomization, each patient in the "Intervention-Rehabilitation through Toap Run" group will have to complete 2 to 3 sessions per week at home with the serious game "TOAP RUN" using the Kinect® system for 1 year. The primary endpoint is a medical-economic endpoint: the difference in incremental cost-utility ratio at 12 months between the 2 groups of patients. Costs will be assessed at inclusion, at the end of 6 and 12 months. Secondary endpoints include clinical and neurophysiological assessments, focusing on gait and balance disorders, as well as cognition and emotional state. An imaging study for patients included in the Paris-ICM center is also planned to study the effects of serious game rehabilitation on brain function. Patients in both groups will be free to use SG at the end of the intervention.

Conditions

• Patients With Parkinson's Disease

Interventions

Type	Name	Description
DEVICE	play-based rehabilitaion	usual re-education treatment by their physiotherapist

Timeline

• Start date: 2023-02-15
• Primary completion: 2029-02-01
• Completion: 2029-02-01
• First posted: 2021-01-22
• Last updated: 2026-02-06

Locations

4 sites across 1 country: France