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VR-based EF Rehabilitation for Pediatric TBI

NCT03611062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-09-14

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

VR Executive Functions Training

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.

BEHAVIORAL

VR Placebo Game

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.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • University of Massachusetts, Lowell

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2020-08-12
Completion
2020-08-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03611062 on ClinicalTrials.gov