Home-based Virtual Reality Rehabilitation for Children With Cerebral Palsy

NCT ID: NCT06478082

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-12
• Study Completion Date: 2023-07-03

Brief Summary

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Children with unilateral Cerebral Palsy

All children have unilateral cerebral palsy and are between 1-18 years old

Group Type: EXPERIMENTAL

Home-based virtual reality training

Intervention Type: DEVICE

8-week training with an advised frequency of 30 minutes per day, for 5 days per week.

Interventions

Home-based virtual reality training

8-week training with an advised frequency of 30 minutes per day, for 5 days per week.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sint Maartenskliniek

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noël Keijsers, Prof.

Role: PRINCIPAL_INVESTIGATOR

Donders Institute for Brain, Cognition and Behavior, Radboud University

Locations

Sint Maartenskliniek

Ubbergen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

885

Identifier Type: -

Identifier Source: org_study_id