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 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.
Study identifier: NCT04720365. Status: RECRUITING. Phase: NA.
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;
- Minimum age: 18 Years
Participating locations
- Chu Bordeaux, Bordeaux
- Chu Lille, Lille
- Gh Pitie Salpetriere, Paris
- Rouen University Hospital, Rouen
Study records are sourced from ClinicalTrials.gov. Confirm current eligibility, recruiting status, and locations in the official record.