NCT02855710

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 4, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

2.8 years

First QC Date

July 27, 2016

Last Update Submit

December 28, 2021

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • Rythmic capacities

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

    3 months

Secondary Outcomes (2)

  • cognitive functions

    3 months

  • Mesure of the neural reorganisation

    3 months

Study Arms (4)

No training

OTHER

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

Other: No Rhythm workers training

Perceptive timing training

OTHER

Parkinsonian Patients with Rhythm Workers training perceptive timing

Other: Rhythm workers training Perceptive timing

Sensorimotor timing training

OTHER

Parkinsonian Patients with Rhythm Workers training sensorimotor timing

Other: Rhythm workers training sensorimotor timing

Healthy volunteers

OTHER

Healthy people with Rhythm Workers training perceptive timing

Other: Rhythm workers training Perceptive timing

Interventions

Rhythm workers training Perceptive timingOTHER

Perceptive timing training

Healthy volunteersPerceptive timing training
Rhythm workers training sensorimotor timingOTHER

Sensorimotor timing training

Sensorimotor timing training
No Rhythm workers trainingOTHER

No training

No training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gui de Chauliac Hospital

Montpellier, 34090, France

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Christian Gény, MD

    University Hospital, Montpellier

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 4, 2016

Study Start

March 4, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2022

Last Updated

December 29, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)