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

Cerebral Palsy Clinical Trial

Official title:

Developing Immersive Gamification Technology System for Rehabilitation Management of Pediatric Patients With Cerebral Palsy and Mobility Limitations (Phase 2 Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06100341
• Other study ID #: AXEL0004
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2023
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: Augmented eXperience E-health Laboratory
• Contact: Maria Eliza R. Aguila, PhD
• Phone: +639178212563
• Email: mraguila1[@]up.edu.ph
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Mobility Limitation

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Philippines	University of the Philippines College of Allied Medical Professions Immersive Technology Laboratory	City Of Manila	National Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Augmented eXperience E-health Laboratory

Country where clinical trial is conducted

Philippines, 

References & Publications (2)

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

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability of the intervention will be qualitatively assessed based on the perceptions of patients, caregivers, and patient advocates	Acceptability will be measured among a small group of patients, caregivers, and patient advocates through an interview and a focus group discussion. More positive perceptions indicate a higher level of acceptability.	Within one week after completing virtual reality experience
Primary	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. 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.	Within one hour after completion of the sixth session
Primary	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.	Within one hour after completion of the sixth session
Primary	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	Within one hour after completion of the sixth session
Primary	Walking speed will be assessed using 10MWT	The 10-meter walk test (10MWT) assesses the walking speed of a child over a short distance	Within one hour after completion of the sixth session
Primary	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	Within one hour after completion of the sixth session
Primary	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.	Within one hour after completion of the sixth session
Primary	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.	Immediately after each intervention, within an hour of completion of the virtual reality game
Primary	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.	Immediately after each intervention, within an hour of completion of the virtual reality game
Primary	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.	Immediately after each intervention, within an hour of completion of the virtual reality game