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

Not Applicable

Recruiting

• Conditions: Cerebral Palsy
• Interventions: Other: Virtual reality

• Registration Number: NCT06100341
• Lead Sponsor: Augmented eXperience E-health Laboratory

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-02
• Study First Submitted: 2023-09-27
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-19
• Last Update Submitted: 2023-10-24
• Study First Posted: 2023-10-25
• Last Update Posted: 2023-10-26
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Head-mounted display (HMD)	Virtual reality	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).
Semi-cave automatic virtual environment (semi-CAVE)	Virtual reality	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

Primary Outcome Measures

Name	Time	Method
Walking speed will be assessed using 10MWT	Within one hour after completion of the sixth session	The 10-meter walk test (10MWT) assesses the walking speed of a child over a short distance
Incidence of virtual reality sickness symptoms will be assessed using the Virtual Reality Sickness Questionnaire	Immediately after each intervention, within an hour of completion of the virtual reality game	The VRSQ will measure a participant's experience with the following symptoms: general discomfort, fatigue, eye strain, difficulty focusing, headache, fullness of head, blurring of vision, dizziness (when eyes are closed), and vertigo. Symptoms will be rated on a 4-point scale: 0 or None, 1 or Slight, 2 or Moderate, and 3 or Severe.
Balance will be assessed using Pediatric Balance Scale	Within one hour after completion of the sixth session	The Pediatric Balance Scale is used to assess skills in functional balance among school-aged children. It rates a child's ability and records the time it takes for a child to maintain balance in different scenarios. Items are rated from 0 to 4, with a minimum score of 0 and a maximum score of 56. Changes are noted to be significant if the Pediatric Balance Scale score improvements are at least 0.79 points for the Pediatric Balance Scale-static scale, 0.96 points for the Pediatric Balance Scale-dynamic scale, and 1.59 points on the Pediatric Balance Scale-total scale.
Gross motor performance will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency (Second Edition; Short Form)	Within one hour after completion of the sixth session	The Bruininks-Oseretsky Test of Motor Proficiency (Second Edition) is a comprehensive test of a child's fine and gross motor skills
Functional ability will be assessed using Bruininks-Oseretsky Test of Motor Proficiency (Second Edition, Short Form)	Within one hour after completion of the sixth session	The Bruininks-Oseretsky Test of Motor Proficiency (Second Edition, Short Form) is a comprehensive test of a child's fine and gross motor skills
Balance will be assessed using the Timed Up and Go in Children	Within one hour after completion of the sixth session	Timed-Up and Go in Children is a timed test of functional dynamic balance where a child is tasked to stand up from a sitting position, walk 3 meters, turn and walk back, and sit down.
Functional ability will be assessed using Timed-Up and Go in Children	Within one hour after completion of the sixth session	Timed-Up and Go in Children is a timed test of functional dynamic balance where a child is tasked to stand up from a sitting position, walk 3 meters, turn and walk back, and sit down.
Usability of the virtual reality intervention will be assessed using a researcher usability checklist	Immediately after each intervention, within an hour of completion of the virtual reality game	Usability will also be measured by the application's performance. Effectiveness will be measured in terms of task completion within a given time period, while efficiency will be measured in terms of ease of use of the controllers and the interface. Satisfaction will be determined through observation of participant reactions.
Usability of the virtual reality intervention will be assessed using the System Usability Scale	Immediately after each intervention, within an hour of completion of the virtual reality game	The SUS is a 10-item questionnaire that is widely used in the evaluation of various kinds and aspects of technology. Each question has five response options ranging from 'Strongly agree' to 'Strongly disagree', which has a corresponding number value. Each response is added and multiplied by 2.5 to obtain the final score that ranges from 0 to 100. A SUS score above 68 is considered above average.

Trial Locations

Locations (1)

University of the Philippines College of Allied Medical Professions Immersive Technology Laboratory; 🇵🇭 City Of Manila, National Capital Region, Philippines