- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02469350
Serious Game for Parkinson's Disease Patients (PARKGAME)
October 31, 2017 updated by: Institut National de la Santé Et de la Recherche Médicale, France
Feasibility and Acceptability Study of Serious Game Rehabilitation Program in Parkinson's Disease Patients With Resistant Gait and Balance Disorders
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
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 Locations
-
-
-
Paris, France, 75013
- ICM, CIC Neurosciences
-
-
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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rehabilitation with serious game
18 rehabilitation sessions with serious game during a 6-8 weeks period
|
Rehabilitation with serious game
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility questionnaire
Time Frame: once a week
|
self-assessment questionnaire
|
once a week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability questionnaire
Time Frame: once a week
|
self-assessment questionnaire
|
once a week
|
biomechanical parameters of gait and balance
Time Frame: at inclusion, 3 weeks, 6 weeks and 18 weeks
|
recordings of centres of foot and mass displacements and velocities
|
at inclusion, 3 weeks, 6 weeks and 18 weeks
|
kinematics parameters of gait and balance
Time Frame: at inclusion, 3 weeks, 6 weeks and 18 weeks
|
range of motion of hip, knee and ankle angles
|
at inclusion, 3 weeks, 6 weeks and 18 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Marie-Laure Welter, MD, PhD, GHPS, APHP, Paris
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
June 1, 2015
Primary Completion (Actual)
May 4, 2017
Study Completion (Actual)
October 4, 2017
Study Registration Dates
First Submitted
May 28, 2015
First Submitted That Met QC Criteria
June 8, 2015
First Posted (Estimate)
June 11, 2015
Study Record Updates
Last Update Posted (Actual)
November 6, 2017
Last Update Submitted That Met QC Criteria
October 31, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C15-12
- RCB (Registry Identifier: 2015-A00277-42)
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.
Clinical Trials on Parkinson's Disease
-
Ohio State UniversityCompletedParkinson's Disease | Parkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease | Parkinson Disease, Idiopathic | Parkinson's Disease, IdiopathicUnited States
-
Assistance Publique - Hôpitaux de ParisFrance Parkinson AssociationUnknownHealthy Controls | Parkinson's Disease With LRRK2 Mutation | Parkinson's Disease Without LRRK2 MutationFrance
-
Merck Sharp & Dohme LLCCompletedParkinson Disease | Idiopathic Parkinson Disease | Idiopathic Parkinson's Disease
-
Universidade Federal de PernambucoCompletedParkinson's Disease.Brazil
-
University Hospital, GrenobleCompletedParkinson's Disease (Disorder)France
-
Neurocrine BiosciencesVoyager TherapeuticsCompletedBrain Diseases | Central Nervous System Diseases | Nervous System Diseases | Parkinson's Disease | Parkinsonian Disorders | Movement Disorders | Neurodegenerative Diseases | Idiopathic Parkinson's Disease | Basal Ganglia DiseaseUnited States
-
Shanghai East HospitalShanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaRecruitingIdiopathic Parkinson's DiseaseChina
-
Beijing Tiantan HospitalRecruitingPD - Parkinson's DiseaseChina
-
Kyowa Kirin Co., Ltd.Kyowa Hakko Kirin Pharma, Inc.CompletedIdiopathic Parkinson's DiseaseUnited States, Canada, Czechia, Germany, Israel, Italy, Poland, Serbia
-
Kyowa Kirin Co., Ltd.Kyowa Hakko Kirin Pharma, Inc.CompletedIdiopathic Parkinson's DiseaseUnited States, Canada, Czechia, Germany, Israel, Italy, Poland, Serbia
Clinical Trials on Serious game
-
Institut National de la Santé Et de la Recherche...Recruiting
-
Laval UniversityUniversité Catholique de LouvainRecruitingAging | Older Adults | Aging WellCanada
-
Pamukkale UniversityRecruitingSerious Game on Hospitalized ChildrenTurkey
-
mona mlikaCompleted
-
Université Paris-SudCompleted
-
Gümüşhane UniversıtyNot yet recruitingEducation | Serious Game | Operating Room Nursing | Surgical Instrument | Sterile Dressing
-
National Taiwan University HospitalEnrolling by invitation
-
VU University of AmsterdamRecruiting
-
Ramsay Générale de SantéEuropean Clinical Trial Experts NetworkRecruitingSerious Game | Dysexecutive SyndromeFrance
-
Assistance Publique - Hôpitaux de ParisRecruitingType 1 DiabetesFrance