NCT04720365Recruiting
Medico-economic Evaluation Rehabilitation by Serious Games at Home for the Management of Patients With Parkinson's Disease Suffering From Gait and Balance Disorders
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 29 Dec 2020
- Start date
- 15 Feb 2023
- Primary completion date
- 1 Feb 2029
- Lead sponsor
- University Hospital, Rouen
- Diseases
- Parkinson disease
- NCT number
- NCT04720365
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 15 Feb 2023 to the primary completion date, 1 Feb 2029
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Parkinson's disease with Hoehn\&Yahr stage 5 corresponding to an inability of the subject to stand or walk alone ;
- Dementia (MMS \< 24 and/or MoCA \< 18) ;
- Presence of an impulse control disorder defined by item 6 of the MDS-UPDRS part I \> 2 ;
Age
- Pregnant woman or woman of childbearing age without contraceptive methods;
Other
- Absence of internet connection at home ;
- Serious pathology interfering with the test ;
- Estimated life expectancy of less than 2 years ;
- Subject in a period of exclusion from further research ;
- Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights and liberty ;
Who the study is looking for
- Diagnosis of idiopathic Parkinson's disease (according to United Kingdom Parkinson's Disease Society Brain Bank \[UKPDD\] criteria) ;
- Age ≥ 18 years ;
- 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);
- Number of falls ≥ 2 in the previous year;
- Stable antiparkinsonian treatments for at least 1 month prior to inclusion in the study ;
- Patient with social health insurance ;
- Person who voluntarily and informedly agreed to participate in the study (signed written consent) ;
- Other medical problems that are stable or do not interfere with the proposed protocol;
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| CHU Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Gh Pitie Salpetriere Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Rouen University Hospital Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.