NCT06478082

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 12, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

2.2 years

First QC Date

March 6, 2024

Last Update Submit

June 26, 2024

Conditions

Cerebral Palsy

Keywords

Home-based rehabilitationVirtual RealityUpper limb

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Melbourne Assessment 2

    Before and after 8-week intervention

  • Wall Arm Reaching Test

    Before and after 8-week intervention

  • Range of motion Elbow

    Before and after 8-week intervention

  • Rang om motion Shoulder

    Before and after 8-week intervention

Study Arms (1)

Children with unilateral Cerebral Palsy

EXPERIMENTAL

All children have unilateral cerebral palsy and are between 1-18 years old

Device: Home-based virtual reality training

Interventions

Home-based virtual reality trainingDEVICE

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

Children with unilateral Cerebral Palsy

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Significant (persisting) motion sickness, or any other related adverse event in VR.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sint Maartenskliniek

Ubbergen, Gelderland, 6574 NA, Netherlands

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Noël Keijsers, Prof.

    Donders Institute for Brain, Cognition and Behavior, Radboud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2024

First Posted

June 27, 2024

Study Start

April 12, 2021

Primary Completion

July 3, 2023

Study Completion

July 3, 2023

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)