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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Philippines

Study Type

Interventional

Intervention

Virtual reality

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Head-mounted display (HMD)

Semi-cave automatic virtual environment (semi-CAVE)

Arm 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).

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

Outcomes

Primary Outcome Measures

Balance will be assessed using Pediatric Balance Scale

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.

Balance will be assessed using the Timed Up and Go in Children

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.

Gross motor performance will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency (Second Edition; Short Form)

The Bruininks-Oseretsky Test of Motor Proficiency (Second Edition) is a comprehensive test of a child's fine and gross motor skills

Walking speed will be assessed using 10MWT

The 10-meter walk test (10MWT) assesses the walking speed of a child over a short distance

Functional ability will be assessed using Bruininks-Oseretsky Test of Motor Proficiency (Second Edition, Short Form)

The Bruininks-Oseretsky Test of Motor Proficiency (Second Edition, Short Form) is a comprehensive test of a child's fine and gross motor skills

Functional ability will be assessed using Timed-Up and Go in Children

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.

Incidence of virtual reality sickness symptoms will be assessed using the Virtual Reality Sickness Questionnaire

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.

Usability of the virtual reality intervention will be assessed using the System Usability Scale

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.

Usability of the virtual reality intervention will be assessed using a researcher usability checklist

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT06100341

First Posted

September 27, 2023

Last Updated

October 19, 2023

Sponsor

Augmented eXperience E-health Laboratory

1. Study Identification

Unique Protocol Identification Number

NCT06100341

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 2, 2023 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Augmented eXperience E-health Laboratory

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Head-mounted display (HMD)

Arm Type

Experimental

Arm 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).

Arm Title

Semi-cave automatic virtual environment (semi-CAVE)

Arm Type

Experimental

Arm 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

Intervention Type

Other

Intervention Name(s)

Virtual reality

Intervention Description

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.

Primary Outcome Measure Information:

Title

Balance will be assessed using Pediatric Balance Scale

Description

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.

Time Frame