CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
VR Executive Functions Training +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03611062
NCT03611062N/ACompleted

A Pilot Study on Virtual Reality-based Rehabilitation for Children With Traumatic Brain Injuries

University of Massachusetts, Lowell·interventional·Posted Aug 2, 2018·Updated Sep 14, 2021

In Brief

A clinical study evaluating VR Executive Functions Training and VR Placebo Game for Traumatic Brain Injury. Completed, enrolled 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 2, 2018
Enrollment StartAug 15, 2018
Primary CompletionAug 12, 2020
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.9 years ago

Interventions

VR Executive Functions Trainingbehavioral

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.

VR Placebo Gamebehavioral

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.