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ACL 재건 후 환자를 위한 단계별 노출 및 마음챙김 명상

2026년 11월 2일 업데이트: University of North Carolina, Chapel Hill

GEMM 시험: ACL 재건 후 환자를 위한 단계별 노출 및 마음챙김 명상

To evaluate the effect of graded exposure and mindfulness meditation after ACLR, the investigators will determine the effect of graded exposure and mindfulness meditation to 1) decrease self-reported injury-related fear and reinjury anxiety, and 2) improve lower extremity reaction time when compared to a waitlist control group.

연구 개요

상세 설명

Injury-related fear after anterior cruciate ligament reconstruction (ACLR) is associated with secondary ACL injury and slower reaction time. Graded exposure (GE) and mindfulness meditation (MM) have reduced injury-related fear, but has not been explored together in patients post-ACLR. GE and MM delivered via the Headspace application is feasible for individuals post-ACLR. GEMM allows athletic trainers' to easily implement MM into their practice. The aim of this randomized single-blinded clinical trial is to determine the efficacy of 5-weeks of GEMM to decrease injury-related fear and reinjury anxiety and improve reaction time in participants 6 months to 10-years post-ACLR. Participants will be randomized into a GEMM group or waitlist control group. Participants will complete the Photographic Series of Sports Activities for ACLR, Reinjury Anxiety Inventory, the Tampa Scale of Kinesiophobia-11 and a lower extremity reaction time task pre and post the 5-week period. The investigators hypothesize that participants in the GEMM group will exhibit decreased injury-related fear and reinjury anxiety and faster reaction time when compared to the waitlist controls.

연구 유형

중재적

등록 (추정된)

50

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

  • 이름: Shelby E Baez, Ph.D., ATC
  • 전화번호: 919-445-1500
  • 이메일: sbaez@unc.edu

연구 장소

    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27514
        • 모병
        • Woollen Gymnasium, 300 South Road
        • 연락하다:
          • Shelby E Baez, Ph.D.., ATC
          • 전화번호: 919-445-1500
          • 이메일: sbaez@unc.edu

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

14년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Ages 14-35 years
  • Have self-reported levels of fear on the Tampa Scale of Kinesiophobia-11 and the Photographic Series of Sports Activities for ACLR
  • Injured their knee playing or training for sports (recreational or organized)
  • Have a history of unilateral ACLR
  • 6 months to 10-years post-ACLR

Exclusion Criteria:

  • History of secondary ACL injury
  • Do not exhibit elevated injury-related fear
  • Concomitant surgeries at the time of ACL reconstruction

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Graded Exposure and Mindfulness Meditation

The participants randomized to the GEMM group will complete 1) written exposure and 2) in vivo exposure and will be asked to rate their task specific fears after baseline tests. Tasks identified to be fearful will be used to develop the graded-hierarchy of fearful situations, and these fearful situations will be addressed in the GEMM. Participants will be instructed to watch a 30-min video that provides education on the rationale of cognitive behavioral therapies, specifically the benefits of exposure therapy and mindfulness meditation. Participants randomized into the GEMM group will also complete 5-weeks of Mobile Mindfulness Meditation. Participants randomized into the GEMM group will be guided through 4, 10-minute Mobile Mindfulness Meditation per week (20 total sessions) via the Headspace mobile application where they will learn the fundamentals of mindfulness meditation and how to apply mindfulness meditation to sports rehabilitation.

Participants will complete graded exposure and will be encouraged to face fear-eliciting situations. Participants will also complete mindfulness meditation guided through the Headspace mobile application. Participants will complete the graded exposure one time per week and will complete the mindfulness meditation 4 times per week.

위약 비교기: Waitlist Control

Participants will be randomized to a waitlist control group. Participants will receive an email stating that they will receive access to 5-weeks of Headspace after 5-weeks. Participants will be also asked to not change their normal routines or download apps for relaxation, meditation, or sleep during 5-weeks. After completion of the outcome assessments at 5-weeks, participants in this group will receive access to 5-weeks of Headspace.

Participants will receive an email stating that they will receive access to 5-weeks of Headspace after 5-weeks. Participants will be also asked to not change their normal routines or download apps for relaxation, meditation, or sleep during 5-weeks. After completion of the outcome assessments at 5-weeks, participants in this group will receive access to 5-weeks of Headspace.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Task Specific Fears
기간: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

The Photographic Series of Sports Activities for ACLR is a patient-reported outcome designed to measure fear of harm of specific tasks through photographical assessment. Patients will be instructed to rate each photograph of sports activities on a scale of 0 to 10, with 0 representing "not harmful at all" and 10 representing "extremely harmful."

Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
Change in Overall Injury-Related Fear
기간: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

The Tampa Scale of Kinesiophobia-11 is a valid and reliable questionnaire that consists of 11-items and evaluates fear of movement and re-injury. A 4-point Likert scale is used to score each item. Scores range from 11-44 with higher scores representing higher kinesiophobia.

AIM 1: Determine the efficacy of GEMM compared to a waitlist control group to decrease injury-related fear and reinjury anxiety in participants with a history of ACLR 1-5 years post-reconstruction.

Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

2차 결과 측정

결과 측정
측정값 설명
기간
Change in Reinjury Anxiety
기간: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

The reinjury anxiety inventory (RIAI) is a valid and reliable 28-item questionnaire of reinjury anxiety which consists of two subscales, rehabilitation reinjury anxiety and reentry into competition reinjury anxiety. A 4-point Likert scale is used to score each item. The RIAI is scored by computing a separate score for the two subscales and adding these scores together for an overall total score. Total score ranges from 0-84 with higher scores representing higher reinjury anxiety

Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5
Change in Lower Extremity Reaction Time
기간: Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

Participants will complete a standardized and novel lower extremity reaction time assessment using the FitLight Trainer. Participants will be instructed to respond to a visual stimulus and deactivate a series of 5 targets arranged in a semicircle with their feet. The protocol will last for 1 minute and completed bilaterally. Test limb order will be counterbalanced between participants. Participants will complete 3 familiarization trials and 1 test trial per limb (ms).

Collected at baseline and post-treatment after completion of the intervention or waitlist control at week 5

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Shelby E Baez, Ph.D., ATC, UNC-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 10월 30일

기본 완료 (추정된)

2027년 7월 31일

연구 완료 (추정된)

2027년 7월 31일

연구 등록 날짜

최초 제출

2023년 6월 26일

QC 기준을 충족하는 최초 제출

2023년 7월 14일

처음 게시됨 (실제)

2023년 7월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 2일

마지막으로 확인됨

2025년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • 23-1412
  • 2223GP01 (기타 보조금/기금 번호: National Athletic Trainers' Research and Education Foundation)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

The proposed research will include data from all patients regardless of successful completion of the proposed experimental protocol; except if a patient withdraws their consent. The final dataset will include demographic information, self-reported knee function and injury-related fear questionnaires, and lower extremity reaction time data. Accompanying the data, a documentation file will be provided containing the methodological procedures used during the collection of the data and providing a key for all variables included within the final dataset. Prior to sharing this data, all personal identifying information will be removed to protect the rights and privacy of the patients.

IPD 공유 기간

Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication.

IPD 공유 액세스 기준

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

To further protect the privacy and confidentiality of the data, the data and associated documentation will be made available only under a data-sharing agreement that provides for: (1) requirements to protect patients' privacy and data confidentiality including appropriate data security; (2) restrictions for the transferring of data to others; (3) commitments that the data will be used for research purposes only and not for a profit-making enterprise, and (4) prohibition of manipulation of data for the purposes of attempting to identify research participants.

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. .

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