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Readiness Outcomes Affecting Return to Sport 2.0: An Intervention Feasibility & Pilot Study (ROAR 2:Pilot)

Primary Purpose

ACL Tear

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mental Skills Coaching
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for ACL Tear focused on measuring ACL tear, Mental Skills, Psychological Readiness

Eligibility Criteria

8 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of a complete anterior cruciate ligament (ACL) tear
  • Undergoing ACL reconstruction at Boston Children's Hospital by a study-participating surgeon
  • Age at time of surgery between 8 and ≤ 25
  • English-speaking

Exclusion Criteria:

  • Torn medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL) requiring reconstruction

Sites / Locations

  • Boston Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Participants will receive mental skills training in addition to receiving standard-of-care ACL reconstruction and follow-up care. The goal of mental skills training is to help athletes maximize performance, reach self-determined goals, and build confidence in their fields of play. Many of the same tools that benefit athletes in sport performance also translate to their injury experience. Mental conditioning helps athletes navigate the many ups and downs that accompany ACL injury and recovery. Athletes are taught techniques to maintain their sport mindset by capitalizing on motivation, consistency, and resilience. One-on-one sessions are athlete-centered, and are designed to encourage exploration and growth through tangible mental skills strategies.

Outcomes

Primary Outcome Measures

ACL-Return to Sports after Injury (ACL-RSI)
Questionnaire used to measure the psychological impact of returning to sport after ACL reconstruction surgery. Patients will complete this questionnaire at the clinic visit when they are cleared to RTS at either their 6-month or 9-month postoperative follow-up clinical visit. There are 12 questions that are rated on a 0-10 scale. Overall, this outcome measure is scored 0-100 (higher score = more psychologically ready to RTS). A score greater than or equal to 77% indicates that the patient is psychologically ready to RTS.
PROMIS Psychological Stress Experience - Bank (CAT version)
Assesses the thoughts or feelings about the world in the context of environmental or internal challenges. Patients will complete at the time of enrollment, any additional clinical visit, including 3 months, 6 months, and/or 9 months after surgery. There are 19 questions that are rated on a 1-5 scale. Overall, this outcome measure is scored 18-95 (lower score = less stress). Raw scores are then converted into T-scores.

Secondary Outcome Measures

Full Information

First Posted
March 7, 2022
Last Updated
August 10, 2023
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05338385
Brief Title
Readiness Outcomes Affecting Return to Sport 2.0: An Intervention Feasibility & Pilot Study
Acronym
ROAR 2:Pilot
Official Title
Readiness Outcomes Affecting Return to Sport 2.0: An Intervention Feasibility & Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 3, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to determine the feasibility of implementing a mental skills training intervention for adolescent athletes who tear their ACL and undergo ACL reconstruction surgery alongside receiving standard-of-care clinical treatment. The study will also determine if the mental skills coaching program has any effect on the psychological readiness of patients to return to sport after undergoing surgery and postoperative recovery and rehabilitation. If feasible and if the mental skills training program shows promising effect on athletes' confidence in returning to sport, a large-scale clinical trial can be explored to assess the relationship between mental skills' impact on readiness to return to sport, which could in turn provide evidence on the benefits of integrating mental skills directly into standard clinical care.
Detailed Description
Approximately 350,000 individuals undergo anterior cruciate ligament (ACL) surgery with using allograft or autograft in the US annually. Even with successful ACL surgery, subsequent ACL tear occurs at a rate of 2-24% in physically active population. Most published reports focused on the young adult population, but few studies have focused on physically active young athletes and their return to sports (RTS) after surgery. As successful RTS following ACL reconstruction can be physically and psychologically challenging, increased attention has been directed to better understand the role a patient's psychological readiness to RTS plays in the rehabilitation phase, but there is an overall need to establish effective tools to help improve psychological readiness to RTS during this phase. Mental skills training aims to improve athlete performance. Individuals involved in collegiate-level sports face the challenge of balancing rigorous athletic and academic demands. Given these demands, there is increasing need for programs to help athletes at varying levels and ages develop the skills necessary to maintain optimal performance. Such programs speak to the need for student-athletes to train their mental game much in the same way they train their physical game. They emphasize the value of and the ability to teach confidence, adaptability, and resilience. Researchers have employed both mindfulness- and psychological skills-based techniques as means to promote student-athlete mental toughness and improved performance outcome. Mindfulness increases nonjudgmental awareness of the present, and is an effective treatment in non-sport related arenas. Psychological skills training educates athletes on how to improve strategies such as imagery, self-talk, goal setting, and arousal regulation. While these interventions may vary somewhat in terms of approach, there is evidence that both tactics positively impact athlete performance. We believe that these theories can be translated to athletes who are recovering from injuries and be used effectively to get patients back to their sports confidently. The goal of mental skills training is to help athletes maximize performance, reach self-determined goals, and build confidence in their fields of play. Many of the same tools that benefit athletes in sport performance also translate to their injury experience. Mental conditioning helps athletes navigate the many ups and downs that accompany ACL injury and recovery. Athletes are taught techniques to maintain their sport mindset by capitalizing on motivation, consistency, and resilience. One-on-one sessions are athlete-centered, and are designed to encourage exploration and growth through tangible mental skills strategies. Topics that may be addressed include mindset awareness, goal setting, stress management, mental imagery, cognitive restructuring, and positive self-talk.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Tear
Keywords
ACL tear, Mental Skills, Psychological Readiness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants will receive mental skills training in addition to receiving standard-of-care ACL reconstruction and follow-up care. The goal of mental skills training is to help athletes maximize performance, reach self-determined goals, and build confidence in their fields of play. Many of the same tools that benefit athletes in sport performance also translate to their injury experience. Mental conditioning helps athletes navigate the many ups and downs that accompany ACL injury and recovery. Athletes are taught techniques to maintain their sport mindset by capitalizing on motivation, consistency, and resilience. One-on-one sessions are athlete-centered, and are designed to encourage exploration and growth through tangible mental skills strategies.
Intervention Type
Behavioral
Intervention Name(s)
Mental Skills Coaching
Intervention Description
Participants will partake in a 1-hour pre-op initial intake, followed by five 30-min follow-up sessions at 2 weeks, 6 weeks, 3 months, 6 months and 9-months post-op. All sessions will be one-on-one with the same master's-level mental skills coach. At each session, the provider will allow time for participants to share their current injury experience to date (i.e. how they are doing, challenges they have encountered). Following this, participants will be introduced to a series of mental skills tools, including but not limited to mindset awareness, motivation, cognitive restructuring, goal setting, and objective performance assessment. Participants will be provided with handouts outlining the strategies addressed to help maintain consistency of mental skills engagement between sessions.
Primary Outcome Measure Information:
Title
ACL-Return to Sports after Injury (ACL-RSI)
Description
Questionnaire used to measure the psychological impact of returning to sport after ACL reconstruction surgery. Patients will complete this questionnaire at the clinic visit when they are cleared to RTS at either their 6-month or 9-month postoperative follow-up clinical visit. There are 12 questions that are rated on a 0-10 scale. Overall, this outcome measure is scored 0-100 (higher score = more psychologically ready to RTS). A score greater than or equal to 77% indicates that the patient is psychologically ready to RTS.
Time Frame
6-9 months postop
Title
PROMIS Psychological Stress Experience - Bank (CAT version)
Description
Assesses the thoughts or feelings about the world in the context of environmental or internal challenges. Patients will complete at the time of enrollment, any additional clinical visit, including 3 months, 6 months, and/or 9 months after surgery. There are 19 questions that are rated on a 1-5 scale. Overall, this outcome measure is scored 18-95 (lower score = less stress). Raw scores are then converted into T-scores.
Time Frame
6-9 months postop
Other Pre-specified Outcome Measures:
Title
Compliance
Description
Compliance will be calculated as the number of mental skills coaching sessions attended out of the six planned visits.
Time Frame
Preop consult, 2 weeks postop, 6 weeks postop, 3 months postop, 6 months postop, 9 months postop
Title
Proportion of Participation
Description
This will be defined as the number of people who agreed to participate in a mental skills course divided by the number of people who were approached.
Time Frame
Preop consult

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of a complete anterior cruciate ligament (ACL) tear Undergoing ACL reconstruction at Boston Children's Hospital by a study-participating surgeon Age at time of surgery between 8 and ≤ 25 English-speaking Exclusion Criteria: Torn medial collateral ligament (MCL), lateral collateral ligament (LCL), or posterior cruciate ligament (PCL) requiring reconstruction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew D Milewski, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02453
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20831399
Citation
Wojtys EM, Brower AM. Anterior cruciate ligament injuries in the prepubescent and adolescent athlete: clinical and research considerations. J Athl Train. 2010 Sep-Oct;45(5):509-12. doi: 10.4085/1062-6050-45.5.509. No abstract available.
Results Reference
background
PubMed Identifier
23722056
Citation
Hettrich CM, Dunn WR, Reinke EK; MOON Group; Spindler KP. The rate of subsequent surgery and predictors after anterior cruciate ligament reconstruction: two- and 6-year follow-up results from a multicenter cohort. Am J Sports Med. 2013 Jul;41(7):1534-40. doi: 10.1177/0363546513490277. Epub 2013 May 30.
Results Reference
background
PubMed Identifier
21776554
Citation
Wright RW, Magnussen RA, Dunn WR, Spindler KP. Ipsilateral graft and contralateral ACL rupture at five years or more following ACL reconstruction: a systematic review. J Bone Joint Surg Am. 2011 Jun 15;93(12):1159-65. doi: 10.2106/JBJS.J.00898.
Results Reference
background
PubMed Identifier
20702858
Citation
Paterno MV, Schmitt LC, Ford KR, Rauh MJ, Myer GD, Huang B, Hewett TE. Biomechanical measures during landing and postural stability predict second anterior cruciate ligament injury after anterior cruciate ligament reconstruction and return to sport. Am J Sports Med. 2010 Oct;38(10):1968-78. doi: 10.1177/0363546510376053. Epub 2010 Aug 11.
Results Reference
background
PubMed Identifier
20713644
Citation
Oiestad BE, Holm I, Aune AK, Gunderson R, Myklebust G, Engebretsen L, Fosdahl MA, Risberg MA. Knee function and prevalence of knee osteoarthritis after anterior cruciate ligament reconstruction: a prospective study with 10 to 15 years of follow-up. Am J Sports Med. 2010 Nov;38(11):2201-10. doi: 10.1177/0363546510373876. Epub 2010 Aug 16.
Results Reference
background
PubMed Identifier
20647299
Citation
Oiestad BE, Holm I, Engebretsen L, Risberg MA. The association between radiographic knee osteoarthritis and knee symptoms, function and quality of life 10-15 years after anterior cruciate ligament reconstruction. Br J Sports Med. 2011 Jun;45(7):583-8. doi: 10.1136/bjsm.2010.073130. Epub 2010 Jul 20.
Results Reference
background
PubMed Identifier
17761605
Citation
Lohmander LS, Englund PM, Dahl LL, Roos EM. The long-term consequence of anterior cruciate ligament and meniscus injuries: osteoarthritis. Am J Sports Med. 2007 Oct;35(10):1756-69. doi: 10.1177/0363546507307396. Epub 2007 Aug 29.
Results Reference
background
Citation
Vealey, S. R. (2007). Mental skills training in sport. In G. Tenenbaum, R. Eklund, & R. Singer (Eds.), Handbook of sport psychology (pp. 287-309). Wiley. Hoboken, NJ.
Results Reference
background
Citation
Humphrey, J. H., Yow, D. A., & Bowden, W. W. (2000). Stress in college athletics: Causes, consequences, coping. The Haworth Half-Court Press. Binghamton, NY.
Results Reference
background
Citation
Kimball, A., & Freysinger, V. J. (2003). Leisure, stress, and coping: The sport participation of collegiate student-athletes. Leisure Sciences, 25(2-3), 115-141.
Results Reference
background
Citation
Papanikolaou, Z., Nikolaidis, D., Patsiaouras, A., & Alexopoulos, P. (2003). The freshman experience: High stress-low grades. Athletic Insight: The On-line Journal of Sport Psychology, 5.
Results Reference
background
PubMed Identifier
29199550
Citation
Sallen J, Hemming K, Richartz A. Facilitating dual careers by improving resistance to chronic stress: effects of an intervention programme for elite student athletes. Eur J Sport Sci. 2018 Feb;18(1):112-122. doi: 10.1080/17461391.2017.1407363. Epub 2017 Dec 3.
Results Reference
background
PubMed Identifier
30763131
Citation
Ajilchi B, Amini HR, Ardakani ZP, Zadeh MM, Kisely S. Applying mindfulness training to enhance the mental toughness and emotional intelligence of amateur basketball players. Australas Psychiatry. 2019 Jun;27(3):291-296. doi: 10.1177/1039856219828119. Epub 2019 Feb 14.
Results Reference
background
PubMed Identifier
33071908
Citation
Jones BJ, Kaur S, Miller M, Spencer RMC. Mindfulness-Based Stress Reduction Benefits Psychological Well-Being, Sleep Quality, and Athletic Performance in Female Collegiate Rowers. Front Psychol. 2020 Sep 18;11:572980. doi: 10.3389/fpsyg.2020.572980. eCollection 2020.
Results Reference
background
PubMed Identifier
27457721
Citation
Rothlin P, Birrer D, Horvath S, Grosse Holtforth M. Psychological skills training and a mindfulness-based intervention to enhance functional athletic performance: design of a randomized controlled trial using ambulatory assessment. BMC Psychol. 2016 Jul 26;4(1):39. doi: 10.1186/s40359-016-0147-y.
Results Reference
background

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Readiness Outcomes Affecting Return to Sport 2.0: An Intervention Feasibility & Pilot Study

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