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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 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.

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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.

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

FieldValue
Enrollment Target 130 participants
Start Date 2024-06-04
Est. Completion 2026-09
Phase NA

What the Registry Record Tells You About NCT05320822

The ClinicalTrials.gov registry entry for NCT05320822 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 178-participant average among 20 other Concussion, Brain trials with a reported enrollment target (27% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 1 distinct geographic area - top geographies include 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.

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