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Trial record 1 of 3 for:    parkgame
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Serious Game for Parkinson's Disease Patients (PARKGAME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469350
Recruitment Status : Completed
First Posted : June 11, 2015
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Serious game Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility and Acceptability Study of Serious Game Rehabilitation Program in Parkinson's Disease Patients With Resistant Gait and Balance Disorders
Actual Study Start Date : June 2015
Actual Primary Completion Date : May 4, 2017
Actual Study Completion Date : October 4, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Rehabilitation with serious game
18 rehabilitation sessions with serious game during a 6-8 weeks period
 Other: Serious game
Rehabilitation with serious game


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility questionnaire [ Time Frame: once a week ]
    self-assessment questionnaire


Secondary Outcome Measures :
  1. Acceptability questionnaire [ Time Frame: once a week ]
    self-assessment questionnaire

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469350


Locations
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France
ICM, CIC Neurosciences
Paris, France, 75013
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: Marie-Laure Welter, MD, PhD GHPS, APHP, Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02469350    
Other Study ID Numbers: C15-12
RCB ( Registry Identifier: 2015-A00277-42 )
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
Gait and balance disorders
serious game
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases