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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06100341
Other study ID # AXEL0004
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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