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실용적인 재활 개입: 활성 재활 연구 (ARM)

2026년 11월 4일 업데이트: University of North Carolina, Chapel Hill

서비스 멤버(SM)의 경미한 외상성 뇌 손상 후 점진적 활동 복귀를 보완하기 위한 실용적인 재활 개입: 활성 재활 연구

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.

연구 개요

상태

모집하지 않고 적극적으로

상세 설명

The study population will be soldiers stationed at Fort Bragg, North Carolina. Allocation to arm will be determined by time (preintervention/current practice (Group 1) vs. intervention/Active Rehab (Group 2)). The study will enroll and follow mild traumatic brain injuries in the study population, presenting to study targeted providers within 2 weeks following mild traumatic brain injury/concussion, over two 9 month periods (n=65 in each period for a total n=130 completing the protocol). Post-injury patient outcomes include military performance, physiological, clinical and psychological health outcomes. Study assessment timepoints include initial post-injury intake, 2-weeks post enrollment (as possible), asymptomatic, and clearance to return to duty. In the first 9-month period (Study Phase 1), the study will evaluate current progressive return to activity practices and patient outcomes following mild traumatic brain injury.

In the second 9-month period (Study Phase 2), soldier participants will complete the Active Rehab protocol. Active Rehab activities will be progressed based on participants' reported symptoms and duty profiles. The intervention will be delivered through provider and study staff education to participants. Outcomes will be compared between the two study phases (current practice vs. Active Rehab). Following data acquisition, investigators will utilize Machine Learning techniques to develop an adaptive clinical Active Rehab protocol for military settings (Study Phase 3). The algorithm will use serial measures of military performance, physiological function, clinical recovery, and psychological health status obtained at acutely and sequentially throughout treatment to direct best options for an individual's Active Rehab protocol progression.

연구 유형

중재적

등록 (실제)

63

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Current active duty military personnel stationed at Fort Bragg, North Carolina.
  • Report to clinic/provider at Fort Bragg and available for recruitment within 2 weeks of mTBI injury date as indicated in medical record.
  • Initial provider diagnosis of mTBI/concussion within 2 weeks of injury, confirmed via medical record.

Exclusion Criteria:

  • Third mTBI/concussion in the past 12 months as indicated by the medical record and/or participant self-report.
  • Symptoms clear at rest and exertion within 48 hours as indicated in medical record and or during study enrollment process.
  • Moderate-Severe TBI, or TBI not meeting the criteria for mTBI as indicated by provider diagnosis.
  • Polytrauma or other injuries preventing completion of initial study assessments in the 2-week window as indicated in initial screening/medical record.

TBI, per the funding opportunity announcement is defined as: "being caused by (1) a direct blow or impact to the head, (2) a penetrating head injury, or (3) an exposure to external forces such as blast waves that disrupt the function of the brain." For the proposed study, only those meeting the VA/Department of Defense severity criteria of mild (normal structural imaging, loss of consciousness 0-30 minutes, alteration of consciousness or mental state up to 24 hours, posttraumatic amnesia up to 24 hours, and Glasgow Coma Scale of 13-15) will be targeted.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Progressive Return to Activity (Group 1)

The current practice, Progressive Return to Activity (PRA) based on Traumatic Brain Injury Center of Excellence (TBICoE) protocols, provides a framework for activity progression based on participant symptom reports and recovery. PRA TBICoE includes a graded approach for clinicians to return participants to pre-injury activities based on the severity of the participant symptoms with and without physical exertion.

Participant will be asked to use symptoms to guide activity from the time of the injury until participant is asymptomatic. Once asymptomatic, participant will begin the PRA TBICoE clinical recommendation. During this time clinicians will document activities in each stage in addition to initial symptom checklist, stage of PRA CoE progression, activity parameters, percentage of rest during the session, participants rating of perceived exertion, and final symptom checklist, session satisfaction rating, and session feedback.

실험적: Active Rehab (Group 2)

Active Rehab includes an adaptive paradigm based on personal characteristics, symptom presentation, and duty requirements that integrate with current progressive return to activity (PRA TBICoE) 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 as reported by the participant.

The intervention consists of 5 phases designed to facilitate an active approach to concussion rehabilitation. Phases are symptom stabilization, impairment reduction, activity integration, recovery acceleration, and military duty specific application. Participants complete phase specific activities under direction of a clinical professional, and progress upon meeting specific requirements.

The Active Rehab protocol builds off of initial chief complaints and duty profile and addresses symptom control followed by a progressive and prescribed integration of activities to full return to duty that should be integrated with the current PRA TBICoE protocols. The specific activity areas in the intervention include low-intensity aerobic exercise that does not exacerbate symptoms, cognition, balance, visual/vestibular, and comfort/ general well-being.

Participants can be progressed daily according to symptom limitations. At least 3-4 sessions each week are recommended based on a trial of sport-related mTBI and other interventions of this type concerning mTBI/concussion. During each phase, low level aerobic exercise that does not significantly exacerbate symptoms, such as nature walks, will be recommended. The additional activity types that may be chosen include cognitive, balance, visual/vestibular, and comfort/general well-being.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Average days to full return to duty clearance
기간: 1 to approximately 360 days

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)

1 to approximately 360 days

2차 결과 측정

결과 측정
측정값 설명
기간
Average days to asymptomatic
기간: 1 to approximately 240 days

Average number of days from injury to asymptomatic, determined as when no neurobehavioral symptom inventory (NSI) symptom is greater than 1.

1 to approximately 240 days
Heart Rate Variability (HRV)
기간: up to approximately 346 days after intervention initiation

Heart rate variability (HRV) will be assessed during seated (parasympathetic dominant) and standing (sympathetic dominant) conditions. The conditions will be assessed over three, five minute intervals. Twice when the participant is seated, and once while the participant is standing. Assessment of these conditions allows for assessment of response to a change in state. Assessed at: Initial visit (Baseline); determination of asymptomatic state (up to approximately 226 days after intervention initiation); clearance to full return to duty after intervention completion (up to approximately 346 days after intervention initiation).

up to approximately 346 days after intervention initiation
Cognitive Status using the Military Acute Concussion Evaluation 2 (MACE 2)
기간: up to approximately 346 days after intervention initiation

The MACE 2 will be used to assess cognitive status after acute injury. The MACE 2 has demonstrated validity, reliability, and sensitivity to concussion. The MACE 2 is a multimodal tool that assists in the assessment and diagnosis of concussion. It contains sections on orientation, immediate memory, concentration, and delayed memory. The sum scores from all sections are used to calculate a total score. Total score ranges from 0-30. Assessed at: Initial visit (Baseline); 2 weeks after intervention initiation, determination of asymptomatic state (up to approximately 226 days after intervention initiation); clearance to full return to duty after intervention completion (up to approximately 346 days after intervention initiation).

up to approximately 346 days after intervention initiation
Near point convergence (NPC)
기간: up to approximately 346 days after intervention initiation

Near-point convergence is a commonly used oculomotor exam that defines the amplitude of convergence or the closest point in space where the participant can hold fusion, and therefore, see one target. Participants complete 3 trials assessing near-point convergence, distance in centimeters, and the average of the three trials is recorded. Assessed at: Initial visit (Baseline); 2 weeks after intervention initiation, determination of asymptomatic state (up to approximately 226 days after intervention initiation); clearance to full return to duty after intervention completion (up to approximately 346 days after intervention initiation).

up to approximately 346 days after intervention initiation
Coordination using the Balance Error Scoring System (BESS) Total Score
기간: up to approximately 346 days after intervention initiation

The Balance Error Scoring System (BESS) is a commonly used measure of static balance and postural stability. A combination of three stances (narrow double leg stance, single leg stance, and tandem stance) and two footing surfaces (firm surface/floor or medium density foam) are used for the test. Each stance is held, with hands on hips and eyes closed, for 20 seconds. Points are given for specific behaviors ("errors"), including opening eyes, lifting hands off hips, or stepping, stumbling or falling. Total score ranges from 0-60. Assessed at: Initial visit (Baseline); 2 weeks after intervention initiation, determination of asymptomatic state (up to approximately 226 days after intervention initiation); clearance to full return to duty after intervention completion (up to approximately 346 days after intervention initiation).

up to approximately 346 days after intervention initiation
Neurobehavioral Symptom Inventory total score and individual symptom scores
기간: up to approximately 346 days after intervention initiation

The Neurobehavioral Symptom Inventory (NSI) is a Department of Defense measure for symptom presentation and resolution. Reliability and validity are well established. Participants rate 22 symptoms from 0 (not present) to 4 (severe interference with activity). Outcomes include total score and any symptom >1 (yes/no).Total score ranges from 0-88. Assessed at: Initial visit (Baseline); 2 weeks after intervention initiation, determination of asymptomatic state (up to approximately 226 days after intervention initiation); clearance to full return to duty after intervention completion (up to approximately 346 days after intervention initiation).

up to approximately 346 days after intervention initiation
Quality of Life Perception (PROMIS)
기간: up to approximately 346 days after intervention initiation

The short version of the PROMIS general scale will be utilized. Participants rate items on scale from 1-5, item scores are summed, and a scale score is computed (range 4-20). Physical function: 4 items (1- unable to do to 5-without any difficulty); anxiety: 4 items (1-never to 5-always); depression: 4 items (1- never to 5-always; fatigue: 4 items (1-not at all to 5-very much); sleep: 4 time (1 to 5); ability to participate in social roles/activities: 4 items (1-always to 5-never); pain interference: 4 items (1-not at all to 5-very much); pain intensity: 1 item (0-no pain to 10-worst pain imaginable). Raw scores are converted to a standardized t-score. Assessed at: Initial visit (Baseline); 2 weeks after intervention initiation, determination of asymptomatic state (up to approximately 226 days after intervention initiation); clearance to full return to duty after intervention completion (up to approximately 346 days after intervention initiation).

up to approximately 346 days after intervention initiation
Health-related fatigue using the Neuro-QOL Fatigue Scale
기간: up to approximately 346 days after intervention initiation

Health-related qualify of life fatigue will be assessed using the Quality of Life (QOL) in Neurological Disorders (Neuro-QOL) Fatigue Scale. This scale has reliability and validity concerning overall quality of life. Answers to all 8 items are summed (range 8-40) for a raw summary score. Raw scores are converted to a standardized t-score. Assessed at: Initial visit (Baseline); 2 weeks after intervention initiation, determination of asymptomatic state (up to approximately 226 days after intervention initiation); clearance to full return to duty after intervention completion (up to approximately 346 days after intervention initiation).

up to approximately 346 days after intervention initiation
Health-related cognition using the Neuro-QOL Cognition Scale
기간: up to approximately 346 days after intervention initiation

Health-related qualify of life cognition will be assessed using the Quality of Life (QOL) in Neurological Disorders (Neuro-QOL) Cognition Scale. This scale has reliability and validity concerning overall quality of life. Answers to all 8 items are summed (range 8-40) for a raw summary score. Raw scores are converted to a standardized t-score. Assessed at: Initial visit (Baseline); 2 weeks after intervention initiation, determination of asymptomatic state (up to approximately 226 days after intervention initiation); clearance to full return to duty after intervention completion (up to approximately 346 days after intervention initiation).

up to approximately 346 days after intervention initiation

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Johna K Register-Mihalik, PhD, University of North Carolina, Chapel Hill

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 6월 4일

기본 완료 (추정된)

2026년 11월 28일

연구 완료 (추정된)

2026년 11월 28일

연구 등록 날짜

최초 제출

2022년 1월 27일

QC 기준을 충족하는 최초 제출

2022년 4월 6일

처음 게시됨 (실제)

2022년 4월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 4일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 20-2904
  • CDMRP-PT190088 (기타 보조금/기금 번호: USAMRAA)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Deidentified individual data that supports the results will be shared, where allowed by the Department of Defense, beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD 공유 기간

9 to 36 months following publication

IPD 공유 액세스 기준

IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC, as allowed by the Department of Defense.

IPD 공유 지원 정보 유형

  • 연구_프로토콜

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다