Serious Games Rehabilitation Programme to Treat Gait and Balance Disorders in PD Patients (PARKGAME-II)

February 4, 2021 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Serious Games Rehabilitation Programme to Treat Gant and Balance Disorders in Patients With Parkinson's Disease

To test the effects of a serious game rehabilitation programme in 50 patients with Parkinson's disease with gait and balance disorders in a randomised controlled study

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Parkinson's disease
  • Gait and balance disorders resistant to dopaminergic medication

Exclusion Criteria:

  • dementia
  • contra-indication to magnetic resonance imaging

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rehabilitation with active serious game
25 patients will perform motor rehabilitation programme using the serious game
Device: Serious game
Serious game with movements
Placebo Comparator: No active serious game
25 patients will not perform motor rehabilitation programme using the serious game
Device: Placebo serious game
Serious game without movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of the time-up-go test
Time Frame: change between baseline and at 6 weeks
change between baseline and at 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of the time-up-go test
Time Frame: change between baseline and at 18 weeks
change between baseline and at 18 weeks
Step length
Time Frame: change between baseline and at 6 weeks
change between baseline and at 6 weeks
step velocity
Time Frame: change between baseline and at 6 weeks
change between baseline and at 6 weeks
Movement disorders Unified Parkinson's disease rating scale
Time Frame: change between baseline and at 6 weeks
change between baseline and at 6 weeks
freezing of gait questionnaire
Time Frame: change between baseline and at 6 weeks
change between baseline and at 6 weeks
Parkinson's disease quality of life scale
Time Frame: change between baseline and at 6 weeks
change between baseline and at 6 weeks
gait and balance scale
Time Frame: change between baseline and at 6 weeks
change between baseline and at 6 weeks
Montreal Cognitive Assessment
Time Frame: change between baseline and at 6 weeks
change between baseline and at 6 weeks
Magnetic resonance imaging
Time Frame: change between baseline and at 6 weeks
change between baseline and at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Marie Laure Welter, PH MD PHD, ICM, 47 bd de l'Hôpital, 75013 Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

June 15, 2018

First Posted (Actual)

June 18, 2018

Study Record Updates

Last Update Posted (Actual)

February 5, 2021

Last Update Submitted That Met QC Criteria

February 4, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C17-07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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