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Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program (UnbrokenACL)

9 octobre 2026 mis à jour par: Inova Health Care Services

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

30

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • États-Unis
    • Virginia
      • Fairfax, Virginia, États-Unis, 22031
        • Inova Health System: Orthopedic, Sports Medicine
        • Contact:
        • Contact:
        • Chercheur principal:
          • Edward Chang, MD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

15 ans à 25 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: 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.
Expérimental: 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.
Autre: Unbroken Comeback

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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Psychological Readiness to Return to Sport Following ACL Reconstruction at 12 Months
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Patient-Reported Knee Function and Quality of Life Following ACL Reconstruction at 12 Months
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Inova Health Care Services

Les enquêteurs

  • Chercheur principal: Edward S Chang, MD, Inova Health Care Services

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

31 octobre 2028

Achèvement de l'étude (Estimé)

31 décembre 2028

Dates d'inscription aux études

Première soumission

25 septembre 2026

Première soumission répondant aux critères de contrôle qualité

25 septembre 2026

Première publication (Réel)

1 octobre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

9 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • INOVA-2026-99

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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