ImGTS for Patients With Cerebral Palsy and With Mobility Limitations

NCT05299905 | Completed

• 1 other identifier: AXEL0002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 first 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 acceptability, usability, and safety in healthy children.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (15)

• Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 1

  Baseline assessment for the presence of cybersickness symptoms for Session 1 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.

  Immediately before Session 1, within an hour of before use of the virtual reality game

• Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 1

  Assessment for the occurrence of cybersickness symptoms for Session 1 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.

  Immediately after Session 1, within an hour of completion of the virtual reality game

• Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 2

  Baseline assessment for the presence of cybersickness symptoms for Session 2 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.

  Immediately before Session 2, within an hour of before use of the virtual reality game

• Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 2

  Assessment for the occurrence of cybersickness symptoms for Session 2 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.

  Immediately after Session 2, within an hour of completion of the virtual reality game

• Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 3

  Baseline assessment for the presence of cybersickness symptoms for Session 3 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.

  Immediately before Session 3, within an hour of before use of the virtual reality game

• Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 3

  Assessment for the occurrence of cybersickness symptoms for Session 3 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.

  Immediately after Session 3, within an hour of completion of the virtual reality game

• Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire before Session 4

  Baseline assessment for the presence of cybersickness symptoms for Session 4 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.

  Immediately before Session 4, within an hour of before use of the virtual reality game

• Number of participants with 'Moderate' or 'Severe' symptoms of cybersickness as assessed by the Virtual Reality Sickness Questionnaire after Session 4

  Assessment for the occurrence of cybersickness symptoms for Session 4 will be done using the Virtual Reality Sickness Questionnaire. The questionnaire uses a 4-point scale (None, Slight, Moderate, Severe) to assess nine symptoms of cybersickness. More 'Severe' symptoms mean lower safety.

  Immediately after Session 4, within an hour of completion of the virtual reality game

• The acceptability of the design for Session 1 will be measured using the Place Probe

  The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion

  Immediately after Session 1, within an hour of completion of the virtual reality game

• The acceptability of the design for Session 2 will be measured using the Place Probe

  The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion

  Immediately after Session 2, within an hour of completion of the virtual reality game

• The acceptability of the design for Session 3 will be measured using the Place Probe

  The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion

  Immediately after Session 3, within an hour of completion of the virtual reality game

• The acceptability of the design for Session 4 will be measured using the Place Probe

  The Place Probe is a questionnaire that is composed of three parts and measures a person's general impression of a place (qualitative), their perception on key features of a place (quantitative), and their feelings of presence (quantitative), respectively. Under key features of place, the virtual environment will be assessed according to 33 pairs of semantic differentials where more positive answers mean a better outcome. Under feelings of presence, higher mean scores mean higher levels of immersion

  Immediately after Session 4, within an hour of completion of the virtual reality game

• Observation of completion of the game in the given time during Session 4 to measure effectiveness of the application

  Effectiveness is a component of usability, and will be assessed through observing completion of the game within the allotted time. If at least 85% of the participants complete the game within the allotted time, the game is said to be effective.

  For one hour during Session 4

• Observation of ease of use of controls and user interaction during Session 4 to measure efficiency of the application during Session 4

  Efficiency is a component of usability that will assess a participant's ease of use of the controls and user interface during the experience. If at least 85% of the participants do not encounter or express difficulties in using the application during the experience, the game is said to be efficient.

  For one hour during Session 4

• Observation of user reactions to measure satisfaction in using the application through during Session 4

  Satisfaction is a component of usability that will assess a participant's enjoyment in using the game. It will be assessed through observing the reaction of the participant during Session 4. If 90% of the participants visibly show or verbally express enjoyment during the experience, the game is said to be satisfactory.

  For one hour during Session 4

Study Arms (2)

Semi-CAVE

EXPERIMENTAL

Procedure: Virtual reality using Semi-CAVE

Head-mounted display system

EXPERIMENTAL

Procedure: Virtual reality using the HMD

Interventions

Virtual reality using Semi-CAVE PROCEDURE

The Semi-CAVE will use two screens positioned at a corner of the room, each with a ceiling-mounted short throw projector in front. The participant will stand in the middle of the area, giving them a viewing angle of roughly 180 degrees. The participant will be wearing a safety harness secured to an overhead guide rail, if necessary. The participant may be standing freely, on a treadmill, or on a step stool depending on the type of activity to be performed. The participant will interact with the system through motion sensors positioned at the corners of the area. To one side of the area will be a sufficiently powerful computer running the software. The projectors will be connected to this computer via HDMI cables or similar.

Semi-CAVE

Virtual reality using the HMD PROCEDURE

The HMD will be a commercially available device that uses handheld controllers to control movement while in the VE. The researchers will use a room-scale set-up where a 3 m x 3 m square space is required. Oculus Quest 2 Controllers will be used to interact with the VE. The user will be positioned at the center of the square by default. A therapist will assist them through a separate program called the Observation Module. This program will let the therapist view what the patient can see in the HMD. This will also be used by the therapist to guide the patient navigate through the VE and give instructions for the activities.

Head-mounted display system

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 6 to 12 years old
• Demonstrates fine and gross motor abilities within the norm for the child's age as measured by the Bruininks-Oseretsky Test of Motor Proficiency Test (BOTMP)

You may not qualify if:

• Previously diagnosed with any developmental disorder including CP
• Has had episodes of seizures or previously diagnosed as having epilepsy
• Has a history of motion sickness
• Unable to follow one-step instructions

Sponsors & Collaborators

• Augmented eXperience E-health Laboratory: lead

Study Sites (1)

College of Allied Medical Professions Clinic for Therapy Services

Manila, National Capital Region, 1000, Philippines

Location

Related Publications (12)

• Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.

  PMID: 23961782 BACKGROUND

• Birckhead B, Khalil C, Liu X, Conovitz S, Rizzo A, Danovitch I, Bullock K, Spiegel B. Recommendations for Methodology of Virtual Reality Clinical Trials in Health Care by an International Working Group: Iterative Study. JMIR Ment Health. 2019 Jan 31;6(1):e11973. doi: 10.2196/11973.

  PMID: 30702436 BACKGROUND

• Chen Y, Fanchiang HD, Howard A. Effectiveness of Virtual Reality in Children With Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Jan 1;98(1):63-77. doi: 10.1093/ptj/pzx107.

  PMID: 29088476 BACKGROUND

• Demers M, Fung K, Subramanian SK, Lemay M, Robert MT. Integration of Motor Learning Principles Into Virtual Reality Interventions for Individuals With Cerebral Palsy: Systematic Review. JMIR Serious Games. 2021 Apr 7;9(2):e23822. doi: 10.2196/23822.

  PMID: 33825690 BACKGROUND

• Kim HK, Park J, Choi Y, Choe M. Virtual reality sickness questionnaire (VRSQ): Motion sickness measurement index in a virtual reality environment. Appl Ergon. 2018 May;69:66-73. doi: 10.1016/j.apergo.2017.12.016. Epub 2018 Jan 16.

  PMID: 29477332 BACKGROUND

• Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21.

  PMID: 23962350 BACKGROUND

• Paulson A, Vargus-Adams J. Overview of Four Functional Classification Systems Commonly Used in Cerebral Palsy. Children (Basel). 2017 Apr 24;4(4):30. doi: 10.3390/children4040030.

  PMID: 28441773 BACKGROUND

• Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.

  PMID: 17370477 BACKGROUND

• Sandlund M, McDonough S, Hager-Ross C. Interactive computer play in rehabilitation of children with sensorimotor disorders: a systematic review. Dev Med Child Neurol. 2009 Mar;51(3):173-9. doi: 10.1111/j.1469-8749.2008.03184.x. Epub 2009 Jan 26.

  PMID: 19191834 BACKGROUND

• Smits-Engelsman BC, Blank R, van der Kaay AC, Mosterd-van der Meijs R, Vlugt-van den Brand E, Polatajko HJ, Wilson PH. Efficacy of interventions to improve motor performance in children with developmental coordination disorder: a combined systematic review and meta-analysis. Dev Med Child Neurol. 2013 Mar;55(3):229-37. doi: 10.1111/dmcn.12008. Epub 2012 Oct 29.

  PMID: 23106530 BACKGROUND

• Weber H, Barr C, Gough C, van den Berg M. How Commercially Available Virtual Reality-Based Interventions Are Delivered and Reported in Gait, Posture, and Balance Rehabilitation: A Systematic Review. Phys Ther. 2020 Sep 28;100(10):1805-1815. doi: 10.1093/ptj/pzaa123.

  PMID: 32691059 BACKGROUND

• Weiss PL, Rand D, Katz N, Kizony R. Video capture virtual reality as a flexible and effective rehabilitation tool. J Neuroeng Rehabil. 2004 Dec 20;1(1):12. doi: 10.1186/1743-0003-1-12.

  PMID: 15679949 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Maria Eliza R Aguila, PhD

  University of the Philippines Manila

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2022
• First Posted: March 29, 2022
• Study Start: April 28, 2022
• Primary Completion: July 22, 2022
• Study Completion: July 22, 2022
• Last Updated: February 1, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PH (1)