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Home-based Virtual Reality Rehabilitation for Children With Cerebral Palsy

Not Applicable
Completed
Conditions
Cerebral Palsy
Interventions
Device: Home-based virtual reality training
Registration Number
NCT06478082
Lead Sponsor
Sint Maartenskliniek
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
13
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Children with unilateral Cerebral PalsyHome-based virtual reality trainingAll children have unilateral cerebral palsy and are between 1-18 years old
Primary Outcome Measures
NameTimeMethod
LogbookDuring the 8-week intervention period

Participants keep a logbook in which they log the date of training, games played, duration of activity and enjoyment of game

System Usability ScaleAfter the 8-week intervention

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

Secondary Outcome Measures
NameTimeMethod
Range of motion ElbowBefore and after 8-week intervention

Passive and active range of motion of the extension of the elbow. Ranging between 0-180 degrees. Closer to 0 indicating better extension.

Rang om motion ShoulderBefore and after 8-week intervention

Passive and active range of motion of the anteflexion of the shoulder. Ranging between 0-180 degrees. Closer to 180 indicating better anteflexion.

Wall Arm Reaching TestBefore and after 8-week intervention

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.

Melbourne Assessment 2Before and after 8-week intervention

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.

Trial Locations

Locations (1)

Sint Maartenskliniek

🇳🇱

Ubbergen, Gelderland, Netherlands

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