ImGTS for Patients With Cerebral Palsy and With Mobility Limitations (Phase 2)

NCT ID: NCT06100341

Last Updated: 2023-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-02
• Study Completion Date: 2023-12-31

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Head-mounted display (HMD)

The HMD system uses a commercially available virtual headset, the Oculus/Meta Quest 2, which allows a user to view a virtual environment in 360 degrees and to interact with the environment using hand-tracking technology (i.e., when a user's hand is projected into the virtual world to be used for interactions and gestures).

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: OTHER

A role-playing game set in a spaceship in outer space where a user will need to accomplish three activities to complete the game. These activities were designed based on typical therapy goals for children with cerebral palsy of improving balance, gross motor performance, walking speed, and functional mobility.

Semi-cave automatic virtual environment (semi-CAVE)

The semi-CAVE system uses projectors and projector screens to provide a 270-degree view of the virtual environment. These projectors are connected to a powerful workstation (desktop computer), which uses HTC Vive trackers and base stations to track user movements and interactions

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: OTHER

A role-playing game set in a spaceship in outer space where a user will need to accomplish three activities to complete the game. These activities were designed based on typical therapy goals for children with cerebral palsy of improving balance, gross motor performance, walking speed, and functional mobility.

Interventions

Virtual reality

A role-playing game set in a spaceship in outer space where a user will need to accomplish three activities to complete the game. These activities were designed based on typical therapy goals for children with cerebral palsy of improving balance, gross motor performance, walking speed, and functional mobility.

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Augmented eXperience E-health Laboratory

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Eliza R. Aguila, PhD

Role: PRINCIPAL_INVESTIGATOR

University of the Philippines Manila

Locations

University of the Philippines College of Allied Medical Professions Immersive Technology Laboratory

Manila, National Capital Region, Philippines

Site Status: RECRUITING

Countries

Philippines

Central Contacts

Maria Eliza R. Aguila, PhD

Role: CONTACT

mraguila1@up.edu.ph

+639178212563

Facility Contacts

Maria Eliza R. Aguila, PhD

Role: primary

mraguila1@up.edu.ph

+639178212563

References

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Other Identifiers

AXEL0004

Identifier Type: -

Identifier Source: org_study_id