An interventional study of Home-based virtual reality training in Cerebral Palsy, sponsored by Sint Maartenskliniek. Completed at 1 site in Netherlands. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-06-27.
Sponsored by Sint Maartenskliniek · Not applicable, Interventional, and Device feasibility
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.
1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.
This study's enrollment of 13 is below the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Sint Maartenskliniek is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
All children have unilateral cerebral palsy and are between 1-18 years old
Device: Home-based virtual reality training
8-week training with an advised frequency of 30 minutes per day, for 5 days per week.
Logbook
Participants keep a logbook in which they log the date of training, games played, duration of activity and enjoyment of game
Time frame: 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
Time frame: After the 8-week intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before and after 8-week intervention
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Sint Maartenskliniek