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

A

Augmented eXperience E-health Laboratory

Status

Enrolling

Conditions

Cerebral Palsy

Treatments

Other: Virtual reality

Study type

Interventional

Funder types

Other

Identifiers

NCT06100341
AXEL0004

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Head-mounted display (HMD)
Experimental group
Description:
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).
Treatment:
Other: Virtual reality
Semi-cave automatic virtual environment (semi-CAVE)
Experimental group
Description:
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
Treatment:
Other: Virtual reality

Trial contacts and locations

1

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Central trial contact

Maria Eliza R. Aguila, PhD

Data sourced from clinicaltrials.gov

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