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
| NCT ID | NCT04720365 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Rouen |
| Condition | Patients With Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-02-15 |
| Primary Completion | 2029-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2023-02-15 with a primary completion date of 2029-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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;
Contact & Investigator
Marie-Laure WELTER, Professor
PRINCIPAL INVESTIGATOR
Rouen Uiniversity Hospital
Frequently Asked Questions
Who can join the NCT04720365 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Patients With Parkinson's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04720365 currently recruiting?
Yes, NCT04720365 is actively recruiting participants. Contact the research team at Nell.Marty@chu-rouen.fr for enrollment information.
Where is the NCT04720365 trial being conducted?
This trial is being conducted at Bordeaux, France, Lille, France, Paris, France, Rouen, France.
Who is sponsoring the NCT04720365 clinical trial?
NCT04720365 is sponsored by University Hospital, Rouen. The principal investigator is Marie-Laure WELTER, Professor at Rouen Uiniversity Hospital. The trial plans to enroll 80 participants.
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