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Clinical Trial Details — Status: Suspended

Administrative data

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

Study information

Verified date December 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Rhythm workers training Perceptive timing
Perceptive timing training
Rhythm workers training sensorimotor timing
Sensorimotor timing training
No Rhythm workers training
No training

Locations

Country Name City State
France Gui de Chauliac Hospital Montpellier

Sponsors (4)

Lead Sponsor Collaborator
University Hospital, Montpellier Laboratory EUROMOV EA 2991, Laboratory Parole et Langage UMR 7309, Université Montpellier

Country where clinical trial is conducted

France, 

Outcome

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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