VR-based EF Rehabilitation for Pediatric TBI
A Pilot Study on Virtual Reality-based Rehabilitation for Children With Traumatic Brain Injuries
2 other identifiers
interventional
27
1 country
1
Brief Summary
Childhood traumatic brain injury (TBI) poses significant impairment in children's executive functions (EFs) for moderate to severe injuries, yet interventions specifically designed for children's EF rehabilitation post-TBI and rigorous clinical trials to establish the safety and efficacy of such interventions remain unavailable. In this study, the investigators will conduct a small-scale pilot randomized clinical trial to evaluate the safety and preliminary efficacy of a novel virtual reality (VR)-based training program for EF rehabilitation for mild complicated to severe childhood TBI. Knowledge from this research will provide empirical evidence for a larger-scale RCT after the conclusion of this pilot study, with the aim to improve the long-term health and quality of life in children with TBI, as well as promote efficiency and effectiveness of future psychological rehabilitation for children with TBI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2018
CompletedFirst Posted
Study publicly available on registry
August 2, 2018
CompletedStudy Start
First participant enrolled
August 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 12, 2020
CompletedResults Posted
Study results publicly available
September 14, 2021
CompletedSeptember 14, 2021
August 1, 2021
2 years
June 15, 2018
July 23, 2021
August 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Level of Simulator Sickness [Feasibility and Safety]
Measured by the Simulator Sickness Questionnaire. Total scores range from 0 to 26, with 0 representing a better outcome of less sickness.
Post-Intervention, up to 30 minutes after intervention
Level of Physical Fatigability [Feasibility and Safety]
Measured by the Borg Rating of Perceived Exertion Scale. Total score ranges from 6 to 20, with 6 being a lower amount of exertion.
Post-Intervention, up to 30 minutes after intervention
Perceived Virtual Reality Experience [Feasibility]
Measured by asking participants to respond to the following question: How much did you like the VR games you just played? Measured on a scale 1-5, with higher values indicating greater enjoyment
Post-Intervention, up to 30 minutes after intervention
Study Arms (2)
VR Executive Functions Training
EXPERIMENTALParticipants will receive training of executive functions in a virtual reality environment.
Control
PLACEBO COMPARATORParticipants will play a virtual reality game using the same hardware and similar environments, but without the training of executive functions.
Interventions
The Windows 10-based VICT program invites children to rescue an animated character named "Lubdub" from a castle. The program consists of three challenging and child-friendly tasks that correspond to the three core EFs.
In this game, children in the control group will use the VR hand controller to cast different types of spells (bees, bouncy balls, sparkler spells) to objects in the virtual world. Objects in the VR world will all react differently to a spell being cast so as to provide children a relaxing and EF-free gaming experience.
Eligibility Criteria
You may qualify if:
- diagnosed with TBI
- between 7 to 17 years old (inclusive)
- lowest post-resuscitation Glasgow Coma Scale (GCS)=13-15 combined with trauma-related abnormalities on neuroimaging or a depressed skull fracture (complicated mild TBI, CDC/NIH definition), GCS=9-12 (moderate TBI, CDC/NIH definition), and GCS=3-8 (severe TBI, CDC/NIH definition)
- fluent in English-based communication
- currently score \<28 on the Agitated Behavior Scale (ABS), indicating mild to no agitation.
You may not qualify if:
- severe physical/visual/cognitive comorbidities secondary to TBI that prevent proper utilization of a VR-based game and valid administration of the study measures
- premorbid neurological disorder or neurodevelopmental issues prior to injury that prevent proper utilization of a VR-based game and valid administration of the study measures
- patients who are restricted from using electronic gaming devices.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Related Publications (1)
Shen J, Lundine JP, Koterba C, Udaipuria S, Busch T, Rausch J, Yeates KO, Crawfis R, Xiang H, Taylor HG. VR-based cognitive rehabilitation for children with traumatic brain injuries: Feasibility and safety. Rehabil Psychol. 2022 Nov;67(4):474-483. doi: 10.1037/rep0000458. Epub 2022 Jul 21.
PMID: 35862105DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jiabin Shen
- Organization
- University of Massachusetts Lowell
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 15, 2018
First Posted
August 2, 2018
Study Start
August 15, 2018
Primary Completion
August 12, 2020
Study Completion
August 12, 2020
Last Updated
September 14, 2021
Results First Posted
September 14, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share