N/A
N=27
VR-based EF Rehabilitation for Pediatric TBI
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT03611062 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcome: Primary: Level of Simulator Sickness [Feasibility and Safety] — 0.16; 0.03 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- VR Executive Functions Training (Behavioral); VR Placebo Game (Behavioral)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- University of Massachusetts, Lowell
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Level of Simulator Sickness [Feasibility and Safety] |
0.16; 0.03 | — |
| PRIMARY Level of Physical Fatigability [Feasibility and Safety] |
6.25; 11.50 | — |
| PRIMARY Perceived Virtual Reality Experience [Feasibility] |
3.75; 4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03611062). 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.