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NCT03560089 Clinical Trial

Serious Games Rehabilitation Programme to Treat Gait and Balance Disorders in PD Patients

Parkinson Disease Clinical Trial

— PARKGAME-II  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03560089
Other study ID # C17-07
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 1, 2018
Est. completion date June 1, 2021

Study information
Verified date February 2021
Source Institut National de la Santé Et de la Recherche Médicale, France
Contact Marie Laure Welter, PH MD PHD
Phone 0142165777
Email marielaure.welter@icm-institute.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date June 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Parkinson's disease - Gait and balance disorders resistant to dopaminergic medication Exclusion Criteria: - dementia - contra-indication to magnetic resonance imaging

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Serious game
Serious game with movements
• Placebo serious game
Serious game without movement

Locations
Country Name City State
France Centre Investigation Clinique- ICM Paris

Sponsors (1)
Lead Sponsor Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

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