Rehabilitation Gaming System for Cerebral Palsy

November 1, 2018 updated by: Paul Verschure, Universitat Pompeu Fabra

Motor and Cognitive Training With the Rehabilitation Gaming System for Patients Affected by Cerebral Palsy

In this study the investigators evaluate the effectivity of Virtual Reality-based rehabilitation protocols for preventing motor deterioration in patients with cerebral palsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

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

  • Spain
      • Barcelona, Spain, 08002
        • Universitat Pompeu Fabra

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

12 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Change from Baseline to week 5 (End of Treatment)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Change from Baseline to week 5 (End of Treatment)
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)
Change from Baseline to week 5 (End of Treatment)
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)
Change from Baseline to week 5 (End of Treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Pompeu Fabra

Investigators

  • Principal Investigator: Paul FMJ Verschure, PhD, Center of Autonomous Systems and Neurorobotics

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.

General Publications

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

November 1, 2016

Primary Completion (ACTUAL)

May 1, 2018

Study Completion (ACTUAL)

May 1, 2018

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (ESTIMATE)

October 19, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 5, 2018

Last Update Submitted That Met QC Criteria

November 1, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VR for Cerebral Palsy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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