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VR Cognitive Rehabiliation for Pediatric TBI

NCT04526639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-10-16

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 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.

Conditions

  • TBI (Traumatic Brain Injury)

Interventions

BEHAVIORAL

Virtual Reality-based Interactive Cognitive Training Program

Three virtual reality-based games designed to train inhibitory control, working memory, and cognitive flexibility among children with TBI

BEHAVIORAL

Placebo Virtual Reality Game

A virtual playground for control group to interact without training executive functions

Sponsors & Collaborators

  • Spaulding Rehabilitation Hospital

    collaborator OTHER

  • Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

    collaborator OTHER

  • University of Massachusetts, Lowell

    lead OTHER

Principal Investigators

  • Jiabin Shen, PhD · University of Massachusetts, Lowell

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-03
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT04526639 on ClinicalTrials.gov