VR Cognitive Rehabiliation for Pediatric TBI
Virtual Reality-based Rehabilitation for Pediatric TBI (R00 Phase)
1 other identifier
interventional
14
1 country
2
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 efficacy of such interventions remain unavailable. In this study, the investigators will conduct a randomized clinical trial to evaluate the efficacy of a novel virtual reality (VR)-based training program for EF rehabilitation for childhood 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 Sep 2021
Typical duration for not_applicable
2 active sites
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
August 18, 2020
CompletedFirst Posted
Study publicly available on registry
August 26, 2020
CompletedStudy Start
First participant enrolled
September 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedResults Posted
Study results publicly available
October 16, 2025
CompletedOctober 16, 2025
September 1, 2025
3 years
August 18, 2020
August 14, 2025
September 30, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
VR-based EF Assessment Task
Performance-based executive function assessment Task in the virtual reality environment built by the research team. There are three tasks within this measurement, each transformed into a z score and summed up to serve as the total score for this measure. A Z-score of 0 in each task represents the sample mean. Higher values represent a better outcome for this measure.
Baseline (at recruitment/before intervention), Post-Intervention (after completion of intervention, up to 2 weeks), Follow-Up (up to 6 months after completion of intervention)
Secondary Outcomes (3)
NIH Toolbox Cognition Battery
Baseline (at recruitment/before intervention), Post-Intervention (after completion of intervention, up to 2 weeks), Follow-Up (up to 6 months after completion of intervention)
Report-based EF Skills
Follow-Up (up to 6 months after completion of intervention)
Health-related Quality of Life
Follow-Up (up to 6 months after completion of intervention)
Other Outcomes (3)
Motion Sickness
Post-Intervention, up to 2 weeks
Perceived Exertion
Post-Intervention, up to 2 weeks
Perceived VR Experience
Post-Intervention, up to 2 weeks
Study Arms (2)
Virtual Reality games for training executive functions
EXPERIMENTALVirtual Reality games for training three core executive functions
Control VR Game on Playground
PLACEBO COMPARATORA relaxing virtual reality game for control group to play in VR playground without training their executive functions
Interventions
Three virtual reality-based games designed to train inhibitory control, working memory, and cognitive flexibility among children with TBI
A virtual playground for control group to interact without training executive functions
Eligibility Criteria
You may qualify if:
- diagnosed with TBI within the past 12 months and under 18 years at the time of injury;
- fluent in English; and 3) Score \<28 on the Agitated Behavior Scale (if available).
You may not qualify if:
- comorbidities or premorbid disorders that prevent proper administration of VR and study measures,
- restriction from using electronic devices,
- post-injury seizure activity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kennedy Krieger Institute
Baltimore, Maryland, 21205, United States
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Shen J, Wang Y, Quinn S, Suskauer SJ, Birch J, Busch T, Svingos A, Crawfis R, Yeates KO, Taylor HG. Efficacy of a virtual reality-based cognitive interactive training program for children with traumatic brain injuries: study protocol for a parallel-group randomized controlled trial. Trials. 2024 Mar 13;25(1):185. doi: 10.1186/s13063-024-08049-1.
PMID: 38481293DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
We encountered significant challenges in patient recruitment during the study period from the pandemic and post-pandemic eras, mostly impacted by significant decrease in available patient volumes as well as shortage and high-turnover of research staff. Recruitment is much lower than anticipated. Therefore, results from this study should be interpreted with caution of the small sample size and variability of the participant characteristics within the sample.
Results Point of Contact
- Title
- Jiabin Shen
- Organization
- University of Massachusetts Lowell
Study Officials
- PRINCIPAL INVESTIGATOR
Jiabin Shen, PhD
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
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor, Psychology
Study Record Dates
First Submitted
August 18, 2020
First Posted
August 26, 2020
Study Start
September 3, 2021
Primary Completion
August 31, 2024
Study Completion
August 31, 2024
Last Updated
October 16, 2025
Results First Posted
October 16, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be deposited to NICHD DASH within one year after the acceptance for publication of the main findings.
- Access Criteria
- The data will be accessible to the public through NICHD DASH under a carefully-constructed and closely-monitored Data Use Agreement (DUA) following the NICHD DASH DUA template. This will ensure that requesters are (1) committed to using the data shared only for research purposes as approved by the requester's institutional IRB and not to identify any individual participant; (2) committed to securing the data shared using appropriate safety measures and computer technology; (3) committed to not redistribute the shared data to third parties not approved in the DUA, and (4) committed to destroying the data shared after analyses for the intended research are completed, among other measures to ensure the confidentiality of data and protection of subjects' privacy.
The de-identified datasets and associated documents will be deposited and made available to the public through NICHD Data and Specimen Hub (DASH). DASH has policies and procedures in place that are fully consistent with the NIH Data Sharing Policies and applicable laws and regulations. The final dataset will include demographic and clinical data associated with the nature and severity of patients' injuries, self/parent-reported psychological and behavioral data, performance data on cognitive outcomes. Submitted data will confirm with relevant data and terminology standards as well as policies at NIH, NICHD, and DASH.