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Home-based Virtual Reality Rehabilitation for Children With Cerebral Palsy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06478082
Enrollment
13
Registered
2024-06-27
Start date
2021-04-12
Completion date
2023-07-03
Last updated
2024-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

Keywords

Home-based rehabilitation, Virtual Reality, Upper limb

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.

Interventions

DEVICEHome-based virtual reality training

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

Sponsors

Sint Maartenskliniek
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
LogbookDuring the 8-week intervention periodParticipants 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 interventionThis 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

MeasureTime frameDescription
Rang om motion ShoulderBefore and after 8-week interventionPassive and active range of motion of the anteflexion of the shoulder. Ranging between 0-180 degrees. Closer to 180 indicating better anteflexion.
Melbourne Assessment 2Before and after 8-week interventionItem 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.
Wall Arm Reaching TestBefore and after 8-week interventionA 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.
Range of motion ElbowBefore and after 8-week interventionPassive and active range of motion of the extension of the elbow. Ranging between 0-180 degrees. Closer to 0 indicating better extension.

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026