Back to resultsRehabilitation Gaming System for Cerebral Palsy
Primary Purpose
Cerebral Palsy, Movement Disorder
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
VR-based motor training
Conventional Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Hemiparesis, Functional independence, Virtual Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Children and Adult patients between 12- 50 years old diagnosed with CP according to Gross Motor Function Classification System (GMFCS). Level of disability between I and IV.
- Ashworth modified clinical scale < 3 (Ashworth, 1964, Bohannon Bohannon and Smith, 1987).
Exclusion Criteria:
- Severe visual impairment.
- Severe cognitive impairment such as mental retardation which impedes the understanding of the task.
Sites / Locations
- Universitat Pompeu Fabra
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VR-based motor training
Conventional Therapy
Arm Description
Subjects will perform 3 different training protocols in Virtual Reality that imply performing tasks of vertical and planar reaching and hitting spheres, or hockey pucks, spaced at different time, speed and color.
Subjects will perform conventional rehabilitation tasks for the upper-extremities that imply vertical and planar reaching movements.
Outcomes
Primary Outcome Measures
Change in motor function of the affected extremity as measured by MACS clinical scale
Secondary Outcome Measures
Change in attention and visuo-perceptive and visuo-constructional apraxia as measured by the WAIS-III scale
Change in motor function of the affected extremity as measured by the Box and Blocks clinical scale
Change in the amount of use of the affected arm during training as measured by the Virtual Reality system
Full Information
NCT ID
NCT02938754
First Posted
June 22, 2016
Last Updated
November 1, 2018
Sponsor
Universitat Pompeu Fabra
1. Study Identification
Unique Protocol Identification Number
NCT02938754
Brief Title
Rehabilitation Gaming System for Cerebral Palsy
Official Title
Motor and Cognitive Training With the Rehabilitation Gaming System for Patients Affected by Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Pompeu Fabra
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study the investigators evaluate the effectivity of Virtual Reality-based rehabilitation protocols for preventing motor deterioration in patients with cerebral palsy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Movement Disorder
Keywords
Hemiparesis, Functional independence, Virtual Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VR-based motor training
Arm Type
Experimental
Arm Description
Subjects will perform 3 different training protocols in Virtual Reality that imply performing tasks of vertical and planar reaching and hitting spheres, or hockey pucks, spaced at different time, speed and color.
Arm Title
Conventional Therapy
Arm Type
Active Comparator
Arm Description
Subjects will perform conventional rehabilitation tasks for the upper-extremities that imply vertical and planar reaching movements.
Intervention Type
Behavioral
Intervention Name(s)
VR-based motor training
Intervention Description
Subjects will perform 3 different training protocols in Virtual Reality that imply performing tasks of vertical and planar reaching and hitting spheres, or hockey pucks, spaced at different time, speed and color.
Intervention Type
Behavioral
Intervention Name(s)
Conventional Therapy
Intervention Description
Subjects will perform conventional rehabilitation tasks for the upper-extremities that imply vertical and planar reaching movements.
Primary Outcome Measure Information:
Title
Change in motor function of the affected extremity as measured by MACS clinical scale
Time Frame
Change from Baseline to week 5 (End of Treatment)
Secondary Outcome Measure Information:
Title
Change in attention and visuo-perceptive and visuo-constructional apraxia as measured by the WAIS-III scale
Time Frame
Change from Baseline to week 5 (End of Treatment)
Title
Change in motor function of the affected extremity as measured by the Box and Blocks clinical scale
Time Frame
Change from Baseline to week 5 (End of Treatment)
Title
Change in the amount of use of the affected arm during training as measured by the Virtual Reality system
Time Frame
Change from Baseline to week 5 (End of Treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children and Adult patients between 12- 50 years old diagnosed with CP according to Gross Motor Function Classification System (GMFCS). Level of disability between I and IV.
Ashworth modified clinical scale < 3 (Ashworth, 1964, Bohannon Bohannon and Smith, 1987).
Exclusion Criteria:
Severe visual impairment.
Severe cognitive impairment such as mental retardation which impedes the understanding of the task.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul FMJ Verschure, PhD
Organizational Affiliation
Center of Autonomous Systems and Neurorobotics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat Pompeu Fabra
City
Barcelona
ZIP/Postal Code
08002
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22871683
Citation
Cameirao MS, Badia SB, Duarte E, Frisoli A, Verschure PF. The combined impact of virtual reality neurorehabilitation and its interfaces on upper extremity functional recovery in patients with chronic stroke. Stroke. 2012 Oct;43(10):2720-8. doi: 10.1161/STROKEAHA.112.653196. Epub 2012 Aug 7.
Results Reference
background
PubMed Identifier
19740220
Citation
Wittenberg GF. Neural plasticity and treatment across the lifespan for motor deficits in cerebral palsy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:130-3. doi: 10.1111/j.1469-8749.2009.03425.x.
Results Reference
background
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Rehabilitation Gaming System for Cerebral Palsy
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