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Clinical Trials/NCT06478082
NCT06478082
Completed
Not Applicable

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

Sint Maartenskliniek1 site in 1 country13 target enrollmentApril 12, 2021
ConditionsCerebral Palsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Sint Maartenskliniek
Enrollment
13
Locations
1
Primary Endpoint
Logbook
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 12, 2021
End Date
July 3, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Logbook

Time Frame: During 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 Scale

Time Frame: After 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 Outcomes

  • Range of motion Elbow(Before and after 8-week intervention)
  • Rang om motion Shoulder(Before and after 8-week intervention)
  • Wall Arm Reaching Test(Before and after 8-week intervention)
  • Melbourne Assessment 2(Before and after 8-week intervention)

Study Sites (1)

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