Home-based Virtual Reality Rehabilitation for Children With Cerebral Palsy

Virtual Reality Gaming to Improve Upper Limb Functionality in Children With Cerebral Palsy

Rationale: In a way, VR-based gaming shows some similarities to Constraint-induced movement therapy. VR games are controlled unimanually or bimanually. When unimanually-controlled games are performed with the affected upper limb, movements of the unaffected hand are completely ineffective. This mimics the principle of forced use. To some degree, also bimanually-controlled games result in a forced use of the affected upper limb.

Additionally, VR could help in the engagement in rehabilitation programs, as virtual environments and gaming increases enjoyment and motivation, and therefore therapy adherence. Accordingly, VR-based gaming may have the potential to improve upper limb functionality in children with CP.

Objective: This study aims to investigate the feasibility of a home-based VR intervention to improve upper limb functionality in children with CP. Sub-objective: The validation of a self-developed upper limb assessment (Upper Limb Reaching Test).

Study population: Children and adolescents with unilateral CP (age 10-18 years old). Intervention: The intervention consists of VR-based rehabilitation with the Oculus Quest device. The training frequency and duration represents 2x15 minutes a day, five days a week, for a total of eight weeks. Therefore, this rehabilitation intervention should represent a total amount of 20 hours of rehabilitation. However, the total dosage is variable as the intervention is self-managed.

Main study parameters/endpoints: Logbook, System Usability Scale, Melbourne Assessment 2, Wall Arm Reaching Test, Elbow and shoulder range of motion.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Home-based virtual reality training

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Ubbergen, Gelderland, Netherlands, 6574 NA
      • Sint Maartenskliniek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• CP children with a unilateral or severely asymmetric, bilateral spastic movement impairment.
• Age 10-18 years old.
• Manual Ability Classification System (MACS) scores I, II or III.
• House classification of 1, 2 or 3.

Exclusion Criteria:

• Significant (persisting) motion sickness, or any other related adverse event in VR.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Children with unilateral Cerebral Palsy; All children have unilateral cerebral palsy and are between 1-18 years old	Device: Home-based virtual reality training; 8-week training with an advised frequency of 30 minutes per day, for 5 days per week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Logbook	Participants keep a logbook in which they log the date of training, games played, duration of activity and enjoyment of game	During the 8-week intervention period
System Usability Scale	This questionnaire consists of 10 items regarding the usability of the virtual reality training. Scores ranging between 0-100, with a higher score indicating better usability	After the 8-week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Melbourne Assessment 2	Item 1,2,10 and 13 were measured to evaluate quality of upper limb movements, specifically reaching movements. Scores ranging between 0-33, with a higher score indicating better arm function.	Before and after 8-week intervention
Wall Arm Reaching Test	A test to evaluate the reaching ability in children with cerebral palsy. Children have to alternate with their arm between the hip and a target on the wall as fast a possible in 30 seconds. Scoring starts at 0 and has no maximum. A higher score, indicates a better arm functioning.	Before and after 8-week intervention
Range of motion Elbow	Passive and active range of motion of the extension of the elbow. Ranging between 0-180 degrees. Closer to 0 indicating better extension.	Before and after 8-week intervention
Rang om motion Shoulder	Passive and active range of motion of the anteflexion of the shoulder. Ranging between 0-180 degrees. Closer to 180 indicating better anteflexion.	Before and after 8-week intervention

Collaborators and Investigators

• Sponsor: Sint Maartenskliniek
• Investigators: Principal Investigator: Noël Keijsers, Prof., Donders Institute for Brain, Cognition and Behavior, Radboud University

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Actual): July 3, 2023
• Study Completion (Actual): July 3, 2023

Study Registration Dates

• First Submitted: March 6, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Upper limb; Virtual Reality; Home-based rehabilitation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 885

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No