Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program (UnbrokenACL)
Evaluating A Comprehensive Psychological Readiness Program To Support Return To Sport After ACL Reconstruction: A Randomized Controlled Pilot Study
The goal of this clinical trial is to learn whether an online mental and emotional support program called ACL Unbroken can help people recovering from ACL reconstruction surgery feel more confident and ready to return to sports when used alongside standard physical therapy.
The main questions this study aims to answer are:
- Does the ACL Unbroken program help people feel more mentally prepared and confident to return to sports after ACL surgery?
- Does the ACL Unbroken program improve recovery outcomes, such as physical performance, return to sports participation, satisfaction with recovery, and reducing the risk of another ACL injury?
Participants in the study will:
- Continue to receive their usual physical therapy and medical care prescribed by their healthcare providers.
- Complete surveys and assessments about their recovery, confidence, readiness to return to sports, and overall recovery experience.
- Be assigned to one of two groups by chance.
- If assigned to the intervention group, receive access to the ACL Unbroken online program, which includes educational lessons and activities focused on goal setting, confidence building, coping with fear of re-injury, stress management, motivation, mindfulness, meditation, visualization, and resilience during recovery.
- If assigned to the comparison group, not receive access to the ACL Unbroken program during the study period.
If there is a comparison group, researchers will compare participants who receive the ACL Unbroken program with participants who receive standard care alone to see whether the program improves psychological readiness, recovery outcomes, and return-to-sport success after ACL reconstruction surgery.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
This study evaluates the ACL Unbroken Program, an online psychological support program, in athletes aged 15 to 25 years who are recovering from primary anterior cruciate ligament (ACL) reconstruction with a bone-patellar tendon-bone autograft. The primary objective is to assess whether adding the ACL Unbroken Program to standard postoperative rehabilitation improves psychological readiness to return to sport and patient-reported outcomes following ACL reconstruction. Secondary objectives include evaluating physical performance outcomes, return-to-sport rates, reinjury incidence, participant satisfaction with recovery, and the feasibility and adherence associated with the program.
This is a single-site, prospective, randomized controlled pilot trial enrolling approximately 30 participants. Participants will be randomized in a 1:1 ratio to receive either standard rehabilitation alone or standard rehabilitation plus access to the ACL Unbroken Program. The study uses an open-label design due to the nature of the intervention, while outcome assessors will be blinded to group assignment when feasible. Participants will be followed for up to 24 months after enrollment.
The ACL Unbroken Program is a commercially available, web-based psychological readiness platform designed to support athletes throughout ACL rehabilitation. The program provides educational content and psychological skills training focused on confidence building, fear of reinjury, resilience, emotional regulation, recovery mindset, goal setting, and return-to-sport readiness. 15 participants, randomly assigned to the intervention group will have access to the ACL Unbroken Program in addition to receiving all standard clinical care and physical therapy prescribed by their healthcare providers.
Key assessments include validated patient-reported outcome measures evaluating psychological readiness, knee function, perceived social support, resilience, and recovery experience, as well as objective physical performance assessments such as quadriceps strength testing, hop testing, agility testing, change-of-direction testing, and movement biomechanics. Long-term follow-up assessments will also evaluate return-to-sport participation, reinjury occurrence, and participant satisfaction with recovery.
Psychological readiness has emerged as a critical factor influencing successful return to sport after ACL reconstruction, yet psychological support is not routinely incorporated into many rehabilitation programs. This study aims to provide preliminary evidence regarding the effectiveness and feasibility of integrating a structured psychological readiness program into standard ACL rehabilitation. Findings from this pilot trial will help inform the design of larger future studies and may contribute to improving recovery outcomes for athletes following ACL reconstruction.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Edward Chang, MD
- 電話番号：(571) 472-0465
- メール：edward.chang@inova.org
研究連絡先のバックアップ
- 名前：Parth Sharma, BS
- 電話番号：(571) 472-0464
- メール：parth.sharma@inova.org
研究場所
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-
Virginia
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Fairfax、Virginia、アメリカ、22031
- Inova Health System: Orthopedic, Sports Medicine
-
コンタクト：
- Edward Chang, MD
- 電話番号：(571) 472-0465
- メール：edward.chang@inova.org
-
コンタクト：
- Parth Sharma, BS
- 電話番号：571-472-0464
- メール：parth.sharma@inova.org
-
主任研究者：
- Edward Chang, MD
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria
- Age 15 to 25 years
- Athlete planning to return to sport after surgery
- Undergoing primary ACL reconstruction with (BTB) Patellar tendon autograft
Exclusion Criteria
- Undergoing primary ACL Reconstruction with a graft source other than (BTB) Patellar tendon autograft
- Multi-ligamentous knee injury requiring repair or reconstruction
- Previous ACL Reconstruction on affected or non-affected lower extremity
- Concomitant articular cartilage procedures
- Patients not planning to return to sport(s) after surgery
- Unable to consistently access wifi or a device to complete the Unbroken Athlete online modular program
- Undergoing 1-1 coaching with a behavioral psychotherapist
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
介入なし：Standard of Care
Subjects in this arm will be randomized. They will not receive the Unbroken Athlete Program. Subjects will follow the standard of care treatment from their care team. |
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|
実験的：ACL Unbroken Athlete Program
Subjects in this arm will be randomized. They will receive the Unbroken Athlete Program. Subjects will follow the standard of care treatment from their care team and complete scheduled online modules as part of the intervention. |
The Unbroken Comeback is an online modular recovery program designed for athletes recovering from injury or surgery that focuses on the mental and emotional aspects of rehabilitation, not just the physical recovery. The program aims to help athletes rebuild confidence, resilience, and mindset so they can return to sport or activity stronger and more prepared. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Psychological Readiness to Return to Sport Following ACL Reconstruction at 12 Months
時間枠：1 Year
|
Psychological readiness will be assessed using the Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) Scale. The ACL-RSI is a 12-item patient-reported outcome measure evaluating emotions, confidence, and risk appraisal related to returning to sport after ACL reconstruction. Scores range from 0 to 100, with higher scores indicating greater psychological readiness to return to sport. The mean ACL-RSI score at 12 months post-operatively will be reported. |
1 Year
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient-Reported Knee Function and Quality of Life Following ACL Reconstruction at 12 Months
時間枠：1 year
|
Patient-reported knee function and quality of life will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS consists of five subscales: Pain, Symptoms, Activities of Daily Living, Sport and Recreation Function, and Knee-Related Quality of Life. Scores for each subscale range from 0 to 100, with higher scores indicating better knee health, function, and quality of life. Mean KOOS subscale scores at 12 months post-operatively will be reported. |
1 year
|
|
Return to Pre-Injury Level of Sport Participation at 12 Months Following ACL Reconstruction
時間枠：1 Year
|
Return to sport will be assessed as the proportion of participants who have returned to their pre-injury sport at the same or higher level of participation by 12 months following ACL reconstruction. Return-to-sport status will be determined through participant self-report and clinical follow-up assessments. Results will be reported as the percentage of participants meeting the return-to-sport criterion |
1 Year
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Edward S Chang, MD、Inova Health Care Services
出版物と役立つリンク
一般刊行物
- Sanders TL, Maradit Kremers H, Bryan AJ, Larson DR, Dahm DL, Levy BA, Stuart MJ, Krych AJ. Incidence of Anterior Cruciate Ligament Tears and Reconstruction: A 21-Year Population-Based Study. Am J Sports Med. 2016 Jun;44(6):1502-7. doi: 10.1177/0363546516629944. Epub 2016 Feb 26.
- Barie A, Sprinckstub T, Huber J, Jaber A. Quadriceps tendon vs. patellar tendon autograft for ACL reconstruction using a hardware-free press-fit fixation technique: comparable stability, function and return-to-sport level but less donor site morbidity in athletes after 10 years. Arch Orthop Trauma Surg. 2020 Oct;140(10):1465-1474. doi: 10.1007/s00402-020-03508-1. Epub 2020 Jun 5.
- Dai W, Leng X, Wang J, Cheng J, Hu X, Ao Y. Quadriceps Tendon Autograft Versus Bone-Patellar Tendon-Bone and Hamstring Tendon Autografts for Anterior Cruciate Ligament Reconstruction: A Systematic Review and Meta-analysis. Am J Sports Med. 2022 Oct;50(12):3425-3439. doi: 10.1177/03635465211030259. Epub 2021 Sep 8.
- Belk JW, Kraeutler MJ, Carver TJ, McCarty EC. Knee Osteoarthritis After Anterior Cruciate Ligament Reconstruction With Bone-Patellar Tendon-Bone Versus Hamstring Tendon Autograft: A Systematic Review of Randomized Controlled Trials. Arthroscopy. 2018 Apr;34(4):1358-1365. doi: 10.1016/j.arthro.2017.11.032. Epub 2018 Feb 1.
- Shani RH, Umpierez E, Nasert M, Hiza EA, Xerogeanes J. Biomechanical Comparison of Quadriceps and Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Arthroscopy. 2016 Jan;32(1):71-5. doi: 10.1016/j.arthro.2015.06.051. Epub 2015 Sep 14.
- Buller LT, Best MJ, Baraga MG, Kaplan LD. Trends in Anterior Cruciate Ligament Reconstruction in the United States. Orthop J Sports Med. 2014 Dec 26;3(1):2325967114563664. doi: 10.1177/2325967114563664. eCollection 2015 Jan.
- Murray MM. Optimizing outcomes of ACL surgery-Is autograft reconstruction the only reasonable option? J Orthop Res. 2021 Sep;39(9):1843-1850. doi: 10.1002/jor.25128. Epub 2021 Jul 16.
- Eggeling L, Breer S, Drenck TC, Frosch KH, Akoto R. Double-Layered Quadriceps Tendon Autografts Provide Lower Failure Rates and Improved Clinical Results Compared With Hamstring Tendon Grafts in Revision ACL Reconstruction. Orthop J Sports Med. 2021 Dec 5;9(12):23259671211046929. doi: 10.1177/23259671211046929. eCollection 2021 Dec.
- Geib TM, Shelton WR, Phelps RA, Clark L. Anterior cruciate ligament reconstruction using quadriceps tendon autograft: intermediate-term outcome. Arthroscopy. 2009 Dec;25(12):1408-14. doi: 10.1016/j.arthro.2009.06.004.
- Smith PA, Stannard JP, Pfeiffer FM, Kuroki K, Bozynski CC, Cook JL. Suspensory Versus Interference Screw Fixation for Arthroscopic Anterior Cruciate Ligament Reconstruction in a Translational Large-Animal Model. Arthroscopy. 2016 Jun;32(6):1086-97. doi: 10.1016/j.arthro.2015.11.026. Epub 2016 Feb 4.
- Debarre L, Daxhelet J, DE Lavigne C, Parmentier C. Anterior cruciate ligament reconstruction with semitendinosus graft, comparative study of two tibial fixation devices. Acta Orthop Belg. 2024 Dec;90(4):595-601. doi: 10.52628/90.4.12152.
- Kaeding CC, Leger-St-Jean B, Magnussen RA. Epidemiology and Diagnosis of Anterior Cruciate Ligament Injuries. Clin Sports Med. 2017 Jan;36(1):1-8. doi: 10.1016/j.csm.2016.08.001. Epub 2016 Oct 4.
- Winkler PW, Vivacqua T, Thomassen S, Lovse L, Lesniak BP, Getgood AMJ, Musahl V. Quadriceps tendon autograft is becoming increasingly popular in revision ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2022 Jan;30(1):149-160. doi: 10.1007/s00167-021-06478-y. Epub 2021 Feb 16.
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- INOVA-2026-99
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
The study team does not currently plan to share individual participant data, as preparing datasets for external distribution would require substantial administrative and resource commitments. If data sharing is pursued in the future, appropriate data-sharing mechanisms, such as a Data Use Agreement (DUA) or Collaborative Agreement, will be implemented before any data are disclosed to external parties.
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。