A Training of the Rhythmic Skills With a Serious Game to Improve Gait and Cognitive Abilities in Parkinson's Disease (RGP)

Rhythm Game Park: a Training of the Rhythmic Skills With a Serious Game to Improve Gait and Cognitive Abilities in Parkinson's Disease

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.

Study Overview

• Status: Suspended
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: No Rhythm workers training; Other: Rhythm workers training Perceptive timing; Other: Rhythm workers training sensorimotor timing

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34090
    • Gui de Chauliac Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: No training; Parkinsonian Patients with no Rhythm Workers training perceptive timing and senrorimotor timing	Other: No Rhythm workers training; No training
Other: Perceptive timing training; Parkinsonian Patients with Rhythm Workers training perceptive timing	Other: Rhythm workers training Perceptive timing; Perceptive timing training
Other: Sensorimotor timing training; Parkinsonian Patients with Rhythm Workers training sensorimotor timing	Other: Rhythm workers training sensorimotor timing; Sensorimotor timing training
Other: Healthy volunteers; Healthy people with Rhythm Workers training perceptive timing	Other: Rhythm workers training Perceptive timing; Perceptive timing training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rythmic capacities	Evaluate the effect of the training of the rythmic capacities (Sensorimotor timing abilities) on the walk and the speak	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cognitive functions	Evaluate the cognitive functions by Neurospsychologic tests	3 months
Mesure of the neural reorganisation	Evaluate the structure et connectivity by MRI	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Université Montpellier; Laboratory Parole et Langage UMR 7309; Laboratory EUROMOV EA 2991
• Investigators: Study Chair: Christian Gény, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: July 27, 2016
• First Submitted That Met QC Criteria: August 1, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 9499

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No