Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rehabilitation Gaming System for Cerebral Palsy

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: NCT02938754
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
Paul Verschure, Universitat Pompeu Fabra

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Movement Disorder Behavioral: VR-based motor training Behavioral: Conventional Therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Motor and Cognitive Training With the Rehabilitation Gaming System for Patients Affected by Cerebral Palsy
Study Start Date : November 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VR-based motor training
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.
Behavioral: VR-based motor training
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.

Active Comparator: Conventional Therapy
Subjects will perform conventional rehabilitation tasks for the upper-extremities that imply vertical and planar reaching movements.
Behavioral: Conventional Therapy
Subjects will perform conventional rehabilitation tasks for the upper-extremities that imply vertical and planar reaching movements.




Primary Outcome Measures :
  1. 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 Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT02938754


Locations
Layout table for location information
Spain
Universitat Pompeu Fabra
Barcelona, Spain, 08002
Sponsors and Collaborators
Universitat Pompeu Fabra
Investigators
Layout table for investigator information
Principal Investigator: Paul FMJ Verschure, PhD Center of Autonomous Systems and Neurorobotics

Publications:
Layout table for additonal information
Responsible Party: Paul Verschure, PhD, Universitat Pompeu Fabra
ClinicalTrials.gov Identifier: NCT02938754     History of Changes
Other Study ID Numbers: VR for Cerebral Palsy
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Paul Verschure, Universitat Pompeu Fabra:
Hemiparesis
Functional independence
Virtual Rehabilitation

Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebral Palsy
Movement Disorders
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases