Status:
UNKNOWN
Medico-economic Evaluation Rehabilitation by Serious Games at Home for the Management of Patients With Parkinson's Disease Suffering From Gait and Balance Disorders
Lead Sponsor:
University Hospital, Rouen
Conditions:
Patients With Parkinson's Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 s...
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 s...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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 ;
- 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 ;
- Pregnant woman or woman of childbearing age without contraceptive methods;
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04720365
Start Date
February 1 2021
End Date
February 1 2025
Last Update
January 22 2021
Active Locations (1)
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1
Rouen University Hospital
Rouen, France, 760031