Back to resultsSerious Games Rehabilitation Programme to Treat Gait and Balance Disorders in PD Patients (PARKGAME-II)
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Serious game
Placebo serious game
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Gait, Rehabilitation, Serious game
Eligibility Criteria
Inclusion Criteria:
- Parkinson's disease
- Gait and balance disorders resistant to dopaminergic medication
Exclusion Criteria:
- dementia
- contra-indication to magnetic resonance imaging
Sites / Locations
- Centre Investigation Clinique- ICMRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Rehabilitation with active serious game
No active serious game
Arm Description
25 patients will perform motor rehabilitation programme using the serious game
25 patients will not perform motor rehabilitation programme using the serious game
Outcomes
Primary Outcome Measures
Duration of the time-up-go test
Secondary Outcome Measures
Duration of the time-up-go test
Step length
step velocity
Movement disorders Unified Parkinson's disease rating scale
freezing of gait questionnaire
Parkinson's disease quality of life scale
gait and balance scale
Montreal Cognitive Assessment
Magnetic resonance imaging
Full Information
NCT ID
NCT03560089
First Posted
May 15, 2018
Last Updated
February 4, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT03560089
Brief Title
Serious Games Rehabilitation Programme to Treat Gait and Balance Disorders in PD Patients
Acronym
PARKGAME-II
Official Title
Serious Games Rehabilitation Programme to Treat Gant and Balance Disorders in Patients With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, Gait, Rehabilitation, Serious game
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Blinded assessment of video
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation with active serious game
Arm Type
Active Comparator
Arm Description
25 patients will perform motor rehabilitation programme using the serious game
Arm Title
No active serious game
Arm Type
Placebo Comparator
Arm Description
25 patients will not perform motor rehabilitation programme using the serious game
Intervention Type
Device
Intervention Name(s)
Serious game
Intervention Description
Serious game with movements
Intervention Type
Device
Intervention Name(s)
Placebo serious game
Intervention Description
Serious game without movement
Primary Outcome Measure Information:
Title
Duration of the time-up-go test
Time Frame
change between baseline and at 6 weeks
Secondary Outcome Measure Information:
Title
Duration of the time-up-go test
Time Frame
change between baseline and at 18 weeks
Title
Step length
Time Frame
change between baseline and at 6 weeks
Title
step velocity
Time Frame
change between baseline and at 6 weeks
Title
Movement disorders Unified Parkinson's disease rating scale
Time Frame
change between baseline and at 6 weeks
Title
freezing of gait questionnaire
Time Frame
change between baseline and at 6 weeks
Title
Parkinson's disease quality of life scale
Time Frame
change between baseline and at 6 weeks
Title
gait and balance scale
Time Frame
change between baseline and at 6 weeks
Title
Montreal Cognitive Assessment
Time Frame
change between baseline and at 6 weeks
Title
Magnetic resonance imaging
Time Frame
change between baseline and at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinson's disease
Gait and balance disorders resistant to dopaminergic medication
Exclusion Criteria:
dementia
contra-indication to magnetic resonance imaging
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Laure Welter, PH MD PHD
Phone
0142165777
Email
marielaure.welter@icm-institute.org
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Laure WELTER, PH MD PHD
Phone
0142165777
Email
marielaure.welter@icm-institute.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Laure Welter, PH MD PHD
Organizational Affiliation
ICM, 47 bd de l'Hôpital, 75013 Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Investigation Clinique- ICM
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Laure Welter
Phone
+33142165777
Email
marie-laure.welter@icm-institute.org
12. IPD Sharing Statement
Learn more about this trial
Serious Games Rehabilitation Programme to Treat Gait and Balance Disorders in PD Patients
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