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NCT03611062 · ClinicalTrials.gov registry record · NA

VR-based EF Rehabilitation for Pediatric TBI

A NA study, sponsored by University of Massachusetts, Lowell.

Completed
Registry status
NA
Development phase
27
Enrollment target

NCT03611062: Completed NA study, sponsored by University of Massachusetts, Lowell.

NCT03611062 is a NA study that has completed, run by University of Massachusetts, Lowell. The registered enrollment target is 27 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03611062, a NA study, has completed, sponsored by University of Massachusetts, Lowell.

COMPLETED
Registry status
NA
Development phase
27 participants
Enrollment target

Study 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.

Primary Outcome

Measured by the Simulator Sickness Questionnaire. Total scores range from 0 to 26, with 0 representing a better outcome of less sickness.

Interventions

  • BEHAVIORAL VR Executive Functions Training
  • BEHAVIORAL VR Placebo Game

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2018-08-15
Est. Completion 2020-08-12
Phase NA

What the finished NCT03611062 record still lists

NCT03611062 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which VR Executive Functions Training is the first listed.

NCT03611062 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03611062 about?

NCT03611062 is a clinical study titled "VR-based EF Rehabilitation for Pediatric TBI". 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 int...

What is the current status of trial NCT03611062?

This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2018-08-15. Estimated completion is 2020-08-12.

What interventions are being tested in trial NCT03611062?

The interventions under investigation include: VR Executive Functions Training (BEHAVIORAL), VR Placebo Game (BEHAVIORAL).

Who is sponsoring clinical trial NCT03611062?

This trial is sponsored by University of Massachusetts, Lowell, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03611062's enrollment target sits among peer trials

27 1708th of 2000 higher than 291 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03611062, the US trial registry maintained by the National Library of Medicine. NCT03611062 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.