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Mental Skills Coaching for ACL Tear (ROAR 2:Pilot Trial)

N/A
Waitlist Available
Led By Matthew D Milewski, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of a complete anterior cruciate ligament (ACL) tear
Age at time of surgery between 8 and ≤ 25
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preop consult, 2 weeks postop, 6 weeks postop, 3 months postop, 6 months postop, 9 months postop
Awards & highlights

ROAR 2:Pilot Trial Summary

This trial will explore if a mental skills training program can help athletes who tear their ACL and need surgery to feel confident about returning to their sport.

Who is the study for?
This trial is for English-speaking adolescent athletes aged 8 to 25 who are undergoing ACL reconstruction surgery at Boston Children's Hospital due to a complete tear. It's not for those with additional severe ligament tears requiring reconstruction.Check my eligibility
What is being tested?
The study tests if mental skills coaching can help young athletes feel more ready to return to sports after ACL surgery and recovery. Participants will receive this training along with standard clinical care, assessing its feasibility and impact.See study design
What are the potential side effects?
Since the intervention involves mental skills coaching rather than medication or physical therapy, traditional side effects are not expected. However, participants may experience varying psychological responses to the training.

ROAR 2:Pilot Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My ACL is completely torn.
Select...
I am between 8 and 25 years old at the time of my surgery.
Select...
I am having ACL surgery at Boston Children's Hospital by a surgeon in the study.

ROAR 2:Pilot Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~preop consult, 2 weeks postop, 6 weeks postop, 3 months postop, 6 months postop, 9 months postop
This trial's timeline: 3 weeks for screening, Varies for treatment, and preop consult, 2 weeks postop, 6 weeks postop, 3 months postop, 6 months postop, 9 months postop for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ACL-Return to Sports after Injury (ACL-RSI)
PROMIS Psychological Stress Experience - Bank (CAT version)
Other outcome measures
Compliance
Proportion of Participation

ROAR 2:Pilot Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
756 Previous Clinical Trials
5,579,134 Total Patients Enrolled
Matthew D Milewski, MDPrincipal InvestigatorBoston Children's Hospital
1 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Mental Skills Coaching Clinical Trial Eligibility Overview. Trial Name: NCT05338385 — N/A
Anterior Cruciate Ligament Tear Research Study Groups: Intervention
Anterior Cruciate Ligament Tear Clinical Trial 2023: Mental Skills Coaching Highlights & Side Effects. Trial Name: NCT05338385 — N/A
Mental Skills Coaching 2023 Treatment Timeline for Medical Study. Trial Name: NCT05338385 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this clinical experiment opened enrollment yet?

"According to clinicaltrials.gov, this study is still open for enrollment and had its initial post date on May 3rd 2022 with a most recent edit occurring June 27th of the same year."

Answered by AI

Does the protocol for this experiment restrict enrollment to adults only?

"The conditions for trial participation necessitate that potential participants be between the ages of 8 to 25 years old. There are 47 studies available for individuals below 18 and 26 trials catered towards seniors above 65 years of age."

Answered by AI

Who is eligible for participation in this experiment?

"This clinical trial seeks 30 participants aged 8 to 25 who have suffered a complete tear in the anterior cruciate ligament (ACL). Furthermore, these patients must meet certain stipulations: they must be English speakers and their surgery should occur at Boston Children's Hospital with one of the participating surgeons."

Answered by AI

How many participants are engaging with this research?

"Affirmative. According to clinicaltrials.gov, this medical exploration began on May 3rd 2022 and was recently amended on June 27th 2022; it is currently recruiting 30 patients from a single site."

Answered by AI
Recent research and studies
~11 spots leftby Mar 2025