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NCT04526639 · ClinicalTrials.gov registry record · NA
VR Cognitive Rehabiliation for Pediatric TBI
A NA study of TBI (Traumatic Brain Injury), sponsored by University of Massachusetts, Lowell.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
- 2
- Study locations
NCT04526639: Completed NA study of TBI (Traumatic Brain Injury), sponsored by University of Massachusetts, Lowell.
NCT04526639 is a NA study of TBI (Traumatic Brain Injury) that has completed, run by University of Massachusetts, Lowell. The registered enrollment target is 14 participants, below the 173-participant average among 20 other TBI (Traumatic Brain Injury) trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04526639, a NA study of TBI (Traumatic Brain Injury), has completed, sponsored by University of Massachusetts, Lowell.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
- 2
- Study locations
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 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.
Primary Outcome
Performance-based executive function assessment Task in the virtual reality environment built by the research team. There are three tasks within this measurement, each transformed into a z score and summed up to serve as the total score for this measure. A Z-score of 0 in each task represents the sample mean. Higher values represent a better outcome for this measure.
Conditions Studied
Interventions
- BEHAVIORAL Virtual Reality-based Interactive Cognitive Training Program
- BEHAVIORAL Placebo Virtual Reality Game
Study Locations (2)
Maryland
- Kennedy Krieger Institute - Baltimore
Massachusetts
- Spaulding Rehabilitation Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2021-09-03 |
| Est. Completion | 2024-08-31 |
| Phase | NA |
What the finished NCT04526639 record still lists
NCT04526639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 173-participant average among 20 other TBI (Traumatic Brain Injury) trials with a reported enrollment target (92% lower).
The record links to 1 condition, with TBI (Traumatic Brain Injury) appearing as the primary indexed condition, and to 2 interventions - of which Virtual Reality-based Interactive Cognitive Training Program is the first listed.
NCT04526639 reports a single indexed study location in Maryland, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04526639 about?
NCT04526639 is a clinical study titled "VR Cognitive Rehabiliation 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 efficacy of such interventions ...
What is the current status of trial NCT04526639?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2021-09-03. Estimated completion is 2024-08-31.
What conditions does trial NCT04526639 study?
This clinical trial studies the following conditions: TBI (Traumatic Brain Injury).
What interventions are being tested in trial NCT04526639?
The interventions under investigation include: Virtual Reality-based Interactive Cognitive Training Program (BEHAVIORAL), Placebo Virtual Reality Game (BEHAVIORAL).
Who is sponsoring clinical trial NCT04526639?
This trial is sponsored by University of Massachusetts, Lowell, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04526639 being conducted?
This trial has 2 study locations across Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for TBI (Traumatic Brain Injury)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04526639's enrollment target sits among peer trials
14 21st of 20 the lowest of 20 other TBI (Traumatic Brain Injury) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other TBI (Traumatic Brain Injury) 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.
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