RECRUITING

A Pragmatic Rehabilitation Intervention: The Active Rehab Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Pragmatic Rehabilitation Intervention to Supplement Progressive Return to Activity Following Mild Traumatic Brain Injury in Service Members (SMs): The Active Rehab Study

Quick Facts

Study Start:2024-06-04
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05320822

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Current active duty military personnel stationed at Fort Bragg, North Carolina.
  2. * Report to clinic/provider at Fort Bragg and available for recruitment within 2 weeks of mTBI injury date as indicated in medical record.
  3. * Initial provider diagnosis of mTBI/concussion within 2 weeks of injury, confirmed via medical record.
  1. * Third mTBI/concussion in the past 12 months as indicated by the medical record and/or participant self-report.
  2. * Symptoms clear at rest and exertion within 48 hours as indicated in medical record and or during study enrollment process.
  3. * Moderate-Severe TBI, or TBI not meeting the criteria for mTBI as indicated by provider diagnosis.
  4. * Polytrauma or other injuries preventing completion of initial study assessments in the 2-week window as indicated in initial screening/medical record.

Contacts and Locations

Study Contact

Johna K Register-Mihalik, PhD
CONTACT
919-962-2702
johnakay@email.unc.edu
Paula Gildner, MPH
CONTACT
919-966-0465
pgildner@unc.edu

Principal Investigator

Johna K Register-Mihalik, PhD
PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill

Study Locations (Sites)

United States Special Operations Command
Fort Liberty, North Carolina, 28310
United States
Womack Army Medical Center
Fort Liberty, North Carolina, 28310
United States

Collaborators and Investigators

Sponsor: University of North Carolina, Chapel Hill

  • Johna K Register-Mihalik, PhD, PRINCIPAL_INVESTIGATOR, University of North Carolina, Chapel Hill

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-04
Study Completion Date2024-12

Study Record Updates

Study Start Date2024-06-04
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • Concussion, Rehabilitation

Additional Relevant MeSH Terms

  • Concussion, Brain