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VR-based EF Rehabilitation for Pediatric TBI
NA trial testing VR Executive Functions Training in Traumatic Brain Injury in 27 participants. Completed in 12 August 2020.
| Lead sponsor | University of Massachusetts, Lowell |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 27 |
| Start date | 15 August 2018 |
| Primary completion | 12 August 2020 |
| Estimated completion | 12 August 2020 |
| Sites | 1 location across United States |
University of Massachusetts, Lowell
Adults 7 to 17, any sex, with Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Measured by the Simulator Sickness Questionnaire. Total scores range from 0 to 26, with 0 representing a better outcome of less sickness.
| Group | Value | 95% CI |
|---|---|---|
| VR Executive Functions Training | 0.16 | ± 0.19 |
| Control | 0.03 | ± 0.04 |
Measured by the Borg Rating of Perceived Exertion Scale. Total score ranges from 6 to 20, with 6 being a lower amount of exertion.
| Group | Value | 95% CI |
|---|---|---|
| VR Executive Functions Training | 6.25 | ± 0.50 |
| Control | 11.50 | ± 2.12 |
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
| Group | Value | 95% CI |
|---|---|---|
| VR Executive Functions Training | 3.75 | ± 0.96 |
| Control | 4 | ± 0 |
Time frame: During the course of the study participation (up to 30 minutes after study completion). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | VR Executive Functions Tra… | Control |
|---|---|---|---|
| Blurry vision / eye strain | Eye disorders | — | — |
| Headache | General disorders | — | — |
Data from ClinicalTrials.gov NCT03611062 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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