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NCT05320822 · ClinicalTrials.gov registry record · NA
A Pragmatic Rehabilitation Intervention: The Active Rehab Study
A NA study of Concussion, Brain, sponsored by University of North Carolina, Chapel Hill.
- Recruiting
- Registry status
- NA
- Development phase
- 130
- Enrollment target
- 2
- Study locations
NCT05320822: Recruiting NA study of Concussion, Brain, sponsored by University of North Carolina, Chapel Hill.
NCT05320822 is a NA study of Concussion, Brain that is actively recruiting participants, run by University of North Carolina, Chapel Hill. The registered enrollment target is 130 participants, below the 178-participant average among 20 other Concussion, Brain trials with a reported enrollment target (27% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05320822, a NA study of Concussion, Brain, is actively recruiting participants, sponsored by University of North Carolina, Chapel Hill.
- RECRUITING
- Registry status
- NA
- Development phase
- 130 participants
- Enrollment target
- 2
- Study locations
Study Summary
The strategic objective of this research line is to examine improving short- and long-term outcomes for soldiers following mild traumatic brain injury (mTBI). The technical objectives are to: 1) conduct a Phase 1 quasi-experimental pragmatic trial testing the potential benefit of provider directed active rehabilitation therapies ("Active Rehab") in accelerating return of injured soldiers back to active duty and improving cognitive and functional limitations following mTBI, and 2) operationalize and disseminate a clinical active rehabilitation algorithm for use in military settings. The central hypothesis is that an active rehabilitation algorithm in the context of the progressive return to activity will improve clinical and functional outcomes, including time to return to duty. The Active Rehab intervention expands on progressive return to activity guidelines by providing activities that can be completed and progressed during Stage 1 of the progressive return to activity protocol, when the participant is at least 24 hours postinjury. Active Rehab includes an adaptive paradigm based on personal characteristics, symptom presentation, and duty requirements that integrate with current progressive return to activity guidelines. Activity progressions consider the initial presentation and changes in participant status during treatment, with the goal of safely accelerating recovery. Severity and presence of symptoms will guide progression: worse, same or better as reported by the participant.
Primary Outcome
Average number of days from injury to clearance to full return to duty (date return to duty as reported by participant when returned to duty with no limitations or restrictions minus date of injury)
Conditions Studied
Interventions
- OTHER Active Rehab (Group 2)
- OTHER Progressive Return to Activity (Group 1)
Study Locations (2)
North Carolina
- United States Special Operations Command - Fort Liberty
- Womack Army Medical Center - Fort Liberty
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2024-06-04 |
| Est. Completion | 2026-09 |
| Phase | NA |
What NCT05320822 shows while recruiting
NCT05320822 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 178-participant average among 20 other Concussion, Brain trials with a reported enrollment target (27% lower).
The record links to 1 condition, with Concussion, Brain appearing as the primary indexed condition, and to 2 interventions - of which Active Rehab (Group 2) is the first listed.
NCT05320822 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05320822 about?
NCT05320822 is a clinical study titled "A Pragmatic Rehabilitation Intervention: The Active Rehab Study". The strategic objective of this research line is to examine improving short- and long-term outcomes for soldiers following mild traumatic brain injury (mTBI). The technical objectives are to: 1) conduct a Phase 1 quasi-experimental pragmatic trial testing the potential benefit of provider directed a...
What is the current status of trial NCT05320822?
This trial is currently recruiting. It is a NA study. The enrollment target is 130 participants. The study started on 2024-06-04. Estimated completion is 2026-09.
What conditions does trial NCT05320822 study?
This clinical trial studies the following conditions: Concussion, Brain.
What interventions are being tested in trial NCT05320822?
The interventions under investigation include: Active Rehab (Group 2) (OTHER), Progressive Return to Activity (Group 1) (OTHER).
Who is sponsoring clinical trial NCT05320822?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05320822 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05320822's enrollment target sits among peer trials
130 10th of 20 higher than 11 of 20 other Concussion, Brain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Concussion, Brain 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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