Home-based Virtual Reality Rehabilitation for Children With Cerebral Palsy
NCT Number: NCT06478082
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cerebral Palsy
Interventions: DEVICE: Home-based virtual reality training
Sponsor: Sint Maartenskliniek
Sex: ALL
Age: CHILD, ADULT
Enrollment: 13
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DEVICE_FEASIBILITY
Start Date: 2021-04-12
Completion Date: 2023-07-03
Locations: Sint Maartenskliniek, Ubbergen, Gelderland, 6574 NA, Netherlands

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.

Primary Outcome Measures: Logbook, Participants keep a logbook in which they log the date of training, games played, duration of activity and enjoyment of game, During the 8-week intervention period|System Usability Scale, 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, After the 8-week intervention
Secondary Outcome Measures: Melbourne Assessment 2, 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., Before and after 8-week intervention|Wall Arm Reaching Test, 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., Before and after 8-week intervention|Range of motion Elbow, Passive and active range of motion of the extension of the elbow. Ranging between 0-180 degrees. Closer to 0 indicating better extension., Before and after 8-week intervention|Rang om motion Shoulder, Passive and active range of motion of the anteflexion of the shoulder. Ranging between 0-180 degrees. Closer to 180 indicating better anteflexion., Before and after 8-week intervention