Serious Game for Parkinson's Disease Patients (PARKGAME)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Serious game
Sponsored by
About this trial
This is an interventional other trial for Parkinson's Disease focused on measuring Gait and balance disorders, serious game
Eligibility Criteria
Inclusion Criteria:
- Parkinson's disease
- Gait and balance disorders
- Chronic bilateral deep brain stimulation of the subthalamic nucleus (> 1 year).
Exclusion Criteria:
- Dementia
- Ongoing severe medical condition that prevented assessments
Sites / Locations
- ICM, CIC Neurosciences
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rehabilitation with serious game
Arm Description
18 rehabilitation sessions with serious game during a 6-8 weeks period
Outcomes
Primary Outcome Measures
Feasibility questionnaire
self-assessment questionnaire
Secondary Outcome Measures
Acceptability questionnaire
self-assessment questionnaire
biomechanical parameters of gait and balance
recordings of centres of foot and mass displacements and velocities
kinematics parameters of gait and balance
range of motion of hip, knee and ankle angles
Full Information
NCT ID
NCT02469350
First Posted
May 28, 2015
Last Updated
October 31, 2017
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT02469350
Brief Title
Serious Game for Parkinson's Disease Patients
Acronym
PARKGAME
Official Title
Feasibility and Acceptability Study of Serious Game Rehabilitation Program in Parkinson's Disease Patients With Resistant Gait and Balance Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
May 4, 2017 (Actual)
Study Completion Date
October 4, 2017 (Actual)
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
No
5. Study Description
Brief Summary
In this study the investigators aim to assess the feasibility and acceptability of a serious game to rehabilitate gait and balance disorders in 10 patients with Parkinson's disease previously operated for deep brain stimulation of the sub thalamic nucleus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Gait and balance disorders, serious game
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rehabilitation with serious game
Arm Type
Experimental
Arm Description
18 rehabilitation sessions with serious game during a 6-8 weeks period
Intervention Type
Other
Intervention Name(s)
Serious game
Intervention Description
Rehabilitation with serious game
Primary Outcome Measure Information:
Title
Feasibility questionnaire
Description
self-assessment questionnaire
Time Frame
once a week
Secondary Outcome Measure Information:
Title
Acceptability questionnaire
Description
self-assessment questionnaire
Time Frame
once a week
Title
biomechanical parameters of gait and balance
Description
recordings of centres of foot and mass displacements and velocities
Time Frame
at inclusion, 3 weeks, 6 weeks and 18 weeks
Title
kinematics parameters of gait and balance
Description
range of motion of hip, knee and ankle angles
Time Frame
at inclusion, 3 weeks, 6 weeks and 18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinson's disease
Gait and balance disorders
Chronic bilateral deep brain stimulation of the subthalamic nucleus (> 1 year).
Exclusion Criteria:
Dementia
Ongoing severe medical condition that prevented assessments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Laure Welter, MD, PhD
Organizational Affiliation
GHPS, APHP, Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICM, CIC Neurosciences
City
Paris
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
29636105
Citation
Nuic D, Vinti M, Karachi C, Foulon P, Van Hamme A, Welter ML. The feasibility and positive effects of a customised videogame rehabilitation programme for freezing of gait and falls in Parkinson's disease patients: a pilot study. J Neuroeng Rehabil. 2018 Apr 10;15(1):31. doi: 10.1186/s12984-018-0375-x.
Results Reference
derived
Learn more about this trial
Serious Game for Parkinson's Disease Patients
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