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ClinicalTrials.gov ID

NCT04720365

Lead Sponsor

University Hospital, RouenOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

80Estimated

Last Update Posted

Feb 6, 2026Actual

Start Date

Feb 15, 2023Actual

Primary Completion Date

Feb 1, 2029Estimated

Completion Date

Feb 1, 2029Estimated

Official Title

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

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.

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.

• Patients With Parkinson's Disease

• play-based rehabilitaion

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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;

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, RouenOTHER

caroline.moreau@chru-lille.fr03 20 44 59 62