N/A
N=14
VR Cognitive Rehabiliation for Pediatric TBI
TBI (Traumatic Brain Injury)
Bottom Line
View on ClinicalTrials.gov: NCT04526639 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: VR-based EF Assessment Task — 1.41; 1.53; 1.71; 1.82 Z-Score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Virtual Reality-based Interactive Cognitive Training Program (Behavioral); Placebo Virtual Reality Game (Behavioral)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- University of Massachusetts, Lowell
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY VR-based EF Assessment Task |
1.41; 1.53; 1.71; 1.82; 1.15; 1.15 | — |
| SECONDARY NIH Toolbox Cognition Battery |
91.11; 90.87; 90.87; 88.83; 87.67; 83.56 | — |
| SECONDARY Report-based EF Skills |
52.00; 50.25; 51.75; 49.67 | — |
| SECONDARY Health-related Quality of Life |
78.88; 75.54; 75.90; 70.67 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- comorbidities or premorbid disorders that prevent proper administration of VR and study measures,
- restriction from using electronic devices,
- post-injury seizure activity.
Data sourced from ClinicalTrials.gov (NCT04526639). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.