Parkinson Disease Clinical Trial
— RGPOfficial title:
Rhythm Game Park: a Training of the Rhythmic Skills With a Serious Game to Improve Gait and Cognitive Abilities in Parkinson's Disease
NCT number | NCT02855710 |
Other study ID # | 9499 |
Secondary ID | |
Status | Suspended |
Phase | N/A |
First received | |
Last updated | |
Start date | March 4, 2016 |
Est. completion date | January 2022 |
Verified date | December 2021 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This project aims at assessing the opposite relation, namely the effect of a training of the general timing abilities on gait in Parkinson's disease. Timing rehabilitation will be done by the means of a serious game. Serious games are more and more used to improve the compliance and the efficacy of reeducaiton programs. Overall, we propose to test a low-cost tool for rehabilitation.
Status | Suspended |
Enrollment | 35 |
Est. completion date | January 2022 |
Est. primary completion date | January 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - age < 18 - good understanding of the nature, the goal and the methodology of the study - signing of the informed consent - being insured with a social security - Diagnostic of idiopathic Parkinson's disease following the Queen Square Brain Bank (Hughes, 1992) - Hoehn et Yahr between 2 and 3 - mild to moderate walk and speech deficits (Item MDS-UPDRS) - stable therapy one month before inclusion for all the duration of the study Exclusion Criteria: - Atypic Parkinson Syndrom (oculomotor troubles, early falls, hallucinations, MoCA<20, early dysautonomy) - dystonia ou dyskinesia preventing from using a tablet (item MDS-UPDRS4.2 >2) - Unable to move without help (walking stick, walker, wheelchair) (item MDS-UPDRS 2.12 >2) - adult protected by law - deprivation of liberty - High propability of non compliance to the protocol - pregnant women, nursing women - moderate to severe auditory trouble - Severe walk fluctuations item MDS-UPDRS 4.4 >2) - Pacemaker or neurosensorial device or heart defebrillator - Cochlear implants - ferromagnetic external bodies claose to the brain - Metallic prothesis - agitated, non cooperative patient - claustrophobic patient - neuro-surgical shunt valves - dental appliance |
Country | Name | City | State |
---|---|---|---|
France | Gui de Chauliac Hospital | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | Laboratory EUROMOV EA 2991, Laboratory Parole et Langage UMR 7309, Université Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rythmic capacities | Evaluate the effect of the training of the rythmic capacities (Sensorimotor timing abilities) on the walk and the speak | 3 months | |
Secondary | cognitive functions | Evaluate the cognitive functions by Neurospsychologic tests | 3 months | |
Secondary | Mesure of the neural reorganisation | Evaluate the structure et connectivity by MRI | 3 months |
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