Rehabilitation Gaming System for Cerebral Palsy

• Sponsor: Universitat Pompeu Fabra (Other)
• Overall Status: Completed
• CT.gov ID: NCT02938754
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Duration (Months): 17.9
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy; Movement Disorder	Behavioral: VR-based motor training; Behavioral: Conventional Therapy	N/A

Study Design

• Study Type: Interventional
• 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: Nov 1, 2016
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: May 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in motor function of the affected extremity as measured by MACS clinical scale [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 [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 [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 [Change from Baseline to week 5 (End of Treatment)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitat Pompeu Fabra	Barcelona		Spain	08002

Sponsors and Collaborators

• Universitat Pompeu Fabra

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• Cameirão 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. Epub 2012 Aug 7.
• 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. Review.

• Responsible Party: Paul Verschure, PhD, Universitat Pompeu Fabra
• ClinicalTrials.gov Identifier: NCT02938754
• Other Study ID Numbers: VR for Cerebral Palsy
• First Posted: Oct 19, 2016
• Last Update Posted: Nov 5, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Paul Verschure, PhD, Universitat Pompeu Fabra: Hemiparesis; Functional independence; Virtual Rehabilitation
• Additional relevant MeSH terms: Cerebral Palsy; Movement Disorders

Study Results

No Results Posted as of Nov 5, 2018