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NCT05338385 · ClinicalTrials.gov registry record · NA
Readiness Outcomes Affecting Return to Sport 2.0: An Intervention Feasibility & Pilot Study
A NA study of ACL Tear, sponsored by Boston Children's Hospital.
- Active
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05338385: Active NA study of ACL Tear, sponsored by Boston Children's Hospital.
NCT05338385 is a NA study of ACL Tear that is active but no longer recruiting, run by Boston Children's Hospital. The registered enrollment target is 30 participants, below the 168-participant average among 6 other ACL Tear trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05338385, a NA study of ACL Tear, is active but no longer recruiting, sponsored by Boston Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 psy
Conditions Studied
Interventions
- BEHAVIORAL Mental Skills Coaching
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Waltham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-05-03 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What the registry record for NCT05338385 still lists
NCT05338385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 168-participant average among 6 other ACL Tear trials with a reported enrollment target (82% lower).
The record links to 1 condition, with ACL Tear appearing as the primary indexed condition, and to 1 intervention - of which Mental Skills Coaching is the first listed.
NCT05338385 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05338385 about?
NCT05338385 is a clinical study titled "Readiness Outcomes Affecting Return to Sport 2.0: An Intervention Feasibility & Pilot Study". 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 pr...
What is the current status of trial NCT05338385?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2022-05-03. Estimated completion is 2025-12-31.
What conditions does trial NCT05338385 study?
This clinical trial studies the following conditions: ACL Tear.
What interventions are being tested in trial NCT05338385?
The interventions under investigation include: Mental Skills Coaching (BEHAVIORAL).
Who is sponsoring clinical trial NCT05338385?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05338385 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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