Clinical trial NCT02855710: A Training of the Rhythmic Skills With a Serious Game to Improve Gait and Cognitive Abilities in Parkinson's Disease
Official title: Rhythm Game Park: a Training of the Rhythmic Skills With a Serious Game to Improve Gait and Cognitive Abilities in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Laboratory Parole et Langage UMR 7309
name: Laboratory EUROMOV EA 2991
name: Université Montpellier
First posted: 2016-08-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Auditory rythmic cueing is a method consisting in presenting a regular auditory stimulus (metronom or music) when someone is walking. It is known to improve gait in pathologies such as Parkinson's disease. It has also an effect on general timing abilities (e.g. tapping the beat of the music). 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. Overal, we propose to test a low-cost tool for rehabilitation.

Eligibility criteria: 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

Primary outcomes:
measure: Rythmic capacities
timeFrame: 3 months
Secondary outcomes:
measure: cognitive functions
timeFrame: 3 months
measure: Mesure of the neural reorganisation
timeFrame: 3 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Gui de Chauliac Hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Christian Gény, MD
role: STUDY_CHAIR
References: