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

Primary Purpose

Parkinson Disease

Status
Suspended
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rhythm workers training Perceptive timing
Rhythm workers training sensorimotor timing
No Rhythm workers training
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Gui de Chauliac Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

No training

Perceptive timing training

Sensorimotor timing training

Healthy volunteers

Arm Description

Parkinsonian Patients with no Rhythm Workers training perceptive timing and senrorimotor timing

Parkinsonian Patients with Rhythm Workers training perceptive timing

Parkinsonian Patients with Rhythm Workers training sensorimotor timing

Healthy people with Rhythm Workers training perceptive timing

Outcomes

Primary Outcome Measures

Rythmic capacities
Evaluate the effect of the training of the rythmic capacities (Sensorimotor timing abilities) on the walk and the speak

Secondary Outcome Measures

cognitive functions
Evaluate the cognitive functions by Neurospsychologic tests
Mesure of the neural reorganisation
Evaluate the structure et connectivity by MRI

Full Information

First Posted
July 27, 2016
Last Updated
December 28, 2021
Sponsor
University Hospital, Montpellier
Collaborators
Laboratory Parole et Langage UMR 7309, Laboratory EUROMOV EA 2991, Université Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT02855710
Brief Title
A Training of the Rhythmic Skills With a Serious Game to Improve Gait and Cognitive Abilities in Parkinson's Disease
Acronym
RGP
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Suspended
Why Stopped
end of inclusion period
Study Start Date
March 4, 2016 (Actual)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Laboratory Parole et Langage UMR 7309, Laboratory EUROMOV EA 2991, Université Montpellier

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No training
Arm Type
Other
Arm Description
Parkinsonian Patients with no Rhythm Workers training perceptive timing and senrorimotor timing
Arm Title
Perceptive timing training
Arm Type
Other
Arm Description
Parkinsonian Patients with Rhythm Workers training perceptive timing
Arm Title
Sensorimotor timing training
Arm Type
Other
Arm Description
Parkinsonian Patients with Rhythm Workers training sensorimotor timing
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Healthy people with Rhythm Workers training perceptive timing
Intervention Type
Other
Intervention Name(s)
Rhythm workers training Perceptive timing
Intervention Description
Perceptive timing training
Intervention Type
Other
Intervention Name(s)
Rhythm workers training sensorimotor timing
Intervention Description
Sensorimotor timing training
Intervention Type
Other
Intervention Name(s)
No Rhythm workers training
Intervention Description
No training
Primary Outcome Measure Information:
Title
Rythmic capacities
Description
Evaluate the effect of the training of the rythmic capacities (Sensorimotor timing abilities) on the walk and the speak
Time Frame
3 months
Secondary Outcome Measure Information:
Title
cognitive functions
Description
Evaluate the cognitive functions by Neurospsychologic tests
Time Frame
3 months
Title
Mesure of the neural reorganisation
Description
Evaluate the structure et connectivity by MRI
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Gény, MD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Study Chair
Facility Information:
Facility Name
Gui de Chauliac Hospital
City
Montpellier
ZIP/Postal Code
34090
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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