Ignite Creation Date:
2024-07-17 @ 10:44 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478082
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2024-03-06
Brief Title:
Home-based Virtual Reality Rehabilitation for Children With Cerebral Palsy
Sponsor:
Sint Maartenskliniek
Organization:
Sint Maartenskliniek
Study Overview
Official Title:
Virtual Reality Gaming to Improve Upper Limb Functionality in Children With Cerebral Palsy
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 parametersendpoints Logbook System Usability Scale Melbourne Assessment 2 Wall Arm Reaching Test Elbow and shoulder range of motion
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 parametersendpoints Logbook System Usability Scale Melbourne Assessment 2 Wall Arm Reaching Test Elbow and shoulder range of motion
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None