Clinical trial NCT06100341: ImGTS for Patients With Cerebral Palsy and With Mobility Limitations (Phase 2)
Official title: Developing Immersive Gamification Technology System for Rehabilitation Management of Pediatric Patients With Cerebral Palsy and Mobility Limitations (Phase 2 Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Augmented eXperience E-health Laboratory
Sponsor class: OTHER
First posted: 2023-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed research project aims to answer the question "Are immersive technology systems effective in the rehabilitation management of pediatric patients with cerebral palsy and with mobility limitations?". The current study is the second of three phases, and it aims to create an immersive gamification technology system for the management of patients with cerebral palsy and with mobility disorders and to determine its clinical effectiveness, safety, and usability among children with mild to moderate cerebral palsy.


Eligibility criteria: Inclusion Criteria:

* Aged 6-12 years old
* Able to walk without a mobility device with limited speed, balance, and/or coordination (equivalent to Gross Motor Function Classification System - Expanded and Revised (GMFCS) Level I or II)
* Can handle objects easily and successfully (equivalent to Manual Ability Classification System, MACS, Level I)
* Able to follow one-step instructions during BOTMP

Exclusion Criteria:

* Children with CP functioning at GMFCS Level III or higher
* Children who are totally dependent (i.e., those who require 100% assistance or support from another adult to complete tasks or for transfers or ambulation)
* Have had episodes of seizures or previously diagnosed as having epilepsy or are taking antiepileptic or seizure medications
* Have significant visual impairment
* Have hearing impairment requiring hearing aid
* Have a history of motion sickness
* Experience claustrophobia

Primary outcomes:
measure: Balance will be assessed using Pediatric Balance Scale
timeFrame: Within one hour after completion of the sixth session
measure: Balance will be assessed using the Timed Up and Go in Children
timeFrame: Within one hour after completion of the sixth session
measure: Gross motor performance will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency (Second Edition; Short Form)
timeFrame: Within one hour after completion of the sixth session
measure: Walking speed will be assessed using 10MWT
timeFrame: Within one hour after completion of the sixth session
measure: Functional ability will be assessed using Bruininks-Oseretsky Test of Motor Proficiency (Second Edition, Short Form)
timeFrame: Within one hour after completion of the sixth session
measure: Functional ability will be assessed using Timed-Up and Go in Children
timeFrame: Within one hour after completion of the sixth session
measure: Incidence of virtual reality sickness symptoms will be assessed using the Virtual Reality Sickness Questionnaire
timeFrame: Immediately after each intervention, within an hour of completion of the virtual reality game
measure: Usability of the virtual reality intervention will be assessed using the System Usability Scale
timeFrame: Immediately after each intervention, within an hour of completion of the virtual reality game
measure: Usability of the virtual reality intervention will be assessed using a researcher usability checklist
timeFrame: Immediately after each intervention, within an hour of completion of the virtual reality game
Secondary outcomes:
Other outcomes:
measure: Acceptability of the intervention will be qualitatively assessed based on the perceptions of patients, caregivers, and patient advocates
timeFrame: Within one week after completing virtual reality experience
Locations:
city: City Of Manila
country: Philippines
facility: University of the Philippines College of Allied Medical Professions Immersive Technology Laboratory
state: National Capital Region
Study officials:
affiliation: University of the Philippines Manila
name: Maria Eliza R. Aguila, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aguila, M.E.R. et al. (2023). Application Design of a Virtual Reality Therapy Game for Patients with Cerebral Palsy. In: Krouska, A., Troussas, C., Caro, J. (eds) Novel & Intelligent Digital Systems: Proceedings of the 2nd International Conference (NiDS 2022). NiDS 2022. Lecture Notes in Networks and Systems, vol 556. Springer, Cham. https://doi.org/10.1007/978-3-031-17601-2_17
citation: Boque, J.C. et al. (2023). Moving in Space: Development Process Analysis on a Virtual Reality Therapy Application for Children with Cerebral Palsy. In: Kabassi, K., Mylonas, P., Caro, J. (eds) Novel & Intelligent Digital Systems: Proceedings of the 3rd International Conference (NiDS 2023). NiDS 2023. Lecture Notes in Networks and Systems, vol 784. Springer, Cham. https://doi.org/10.1007/978-3-031-44146-2_20