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Completed

NCT Number: NCT06478082

Home-based Virtual Reality Rehabilitation for 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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sint Maartenskliniek

Ubbergen, Gelderland, 6574 NA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home-based virtual reality training

Device

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

Primary outcomes

  1. 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

  2. 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

  1. Melbourne Assessment 2

    Time frame: Before 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.

  2. Wall Arm Reaching Test

    Time frame: Before 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.

  3. Range of motion Elbow

    Time frame: Before 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.

  4. Rang om motion Shoulder

    Time frame: Before 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.

Sponsors and collaborators

Lead sponsor

Sint Maartenskliniek

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2024
Registry last updated
Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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