ACL Reconstruction Rehabilitation With Exercise and Psychological Support

NCT06991192 | Recruiting

• 2 other identifiers: A23-019R21AR082572
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine ACLR Rehabilitation with Exercise and Psychological Support (REPS), comparing two approaches for providing psychological support along with exercise during ACL reconstruction rehabilitation. In one group, physical therapists have received training that may boost emotional support during rehabilitation. In the other group, physical therapists will not have the training. Both groups will get similar exercises and participate in the same testing. Both groups will also watch short videos during rehabilitation that are specific to their group. Participants will not know to which group they are assigned until the end of the study. Participation will attend a total of four study visits over the course of 6 months, including 1 visit before the surgery and 3 visits during follow-up.

Conditions

Anterior Cruciate Ligament Reconstruction Rehabilitation

Keywords

ACL Reconstruction; Anterior Cruciate Ligament; Rehabilitation; Psychological

Outcome Measures

Primary Outcomes (2)

• ACL Return to Sport after Injury (ACL-RSI)

  The ACL Return to Sport after Injury (ACL-RSI) scale has 12-items in the domains of emotions, confidence, and risk appraisal. Scores range from 0 to 100, and higher scores indicate greater psychological readiness for sport. ACL-RSI has acceptable validity and test-retest reliability.

  Pre-surgery (baseline), prior to first post-surgical rehabilitation visit , 3-months post-surgery, 6-months post-surgery

• International Knee Documentation Committee (IKDC) Subjective Form

  International Knee Documentation Committee (IKDC) subjective form assesses self-reported knee symptoms and function. It is responsive and reliable across knee pathologies, including ACL reconstruction, and has been used as an outcome in federally-funded ACL reconstruction registries and clinical trials. IKDC scores range from 0 to 100 points, and higher scores indicate better knee function.

  Pre-surgery (baseline), prior to first post-surgical rehabilitation visit , 3-months post-surgery, 6-months post-surgery

Secondary Outcomes (7)

• Tampa Scale for Kinesiophobia (TSK-11)

  Pre-surgery (baseline), prior to first post-surgical rehabilitation visit , 3-months post-surgery, 6-months post-surgery

• Clinical Test (Knee pain)

  3-months and 6-months post-surgery

• Clinical Test (Knee range of motion)

  3-months and 6-months post-surgery

• Clinical Test (Quadriceps strength)

  3-months and 6-months post-surgery

• Clinical Test (Countermovement jump)

  6-months post-surgery

Other Outcomes (6)

• Feasibility: Enrollment Rate

  From the date when study enrollment was initiated until the last study participant is enrolled, up to 24 months

• Feasibility: Drop-out Rate

  From enrollment to 6-months post-surgery

• Acceptability: REPS Patient Experience

  6-months post-surgery

Study Arms (2)

Standard Rehabilitation

NO INTERVENTION

TRIA rehabilitation protocols for ACL reconstruction with bone-patellar tendon-bone autograft or ACL reconstruction with meniscal repair will be used for prescribing exercise. Physical therapists may use adjunctive modalities such as neuromuscular electrical stimulation, blood flow restriction, manual therapy, and cryotherapy at their discretion. Exercise videos prescribed to study participants will be housed in an individual online account per standard clinical procedure (MedBridge, Bellevue, WA).

Psychological Support (REPS)

EXPERIMENTAL

Study participants in Rehabilitation with Exercise and Psychological Support (REPS) will receive the standard rehabilitation treatment AND psychological support through a combination of PT training and patient training videos.

Behavioral: Rehabilitation with Exercise and Psychological Support (REPS)

Interventions

Rehabilitation with Exercise and Psychological Support (REPS) BEHAVIORAL

Rehabilitation with Exercise and Psychological Support (REPS) is a rehabilitation approach that integrates exercise with psychological support provided by physical therapist and patient training videos.

Psychological Support (REPS)

Eligibility Criteria

• Age: 15 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 15 to 21 years at the time of surgery;
• Pre-injury Tegner Activity Rating60 ≥ 5 (5=recreational sports, 10=elite sports);
• Sports participation at least 100 hours/year prior to injury;
• Intent to resume a pre-injury sport that requires cutting, jumping, or pivoting;
• ACL reconstruction performed ≤ 6 months from injury;
• ACL reconstruction performed with bone-patellar tendon-bone autograft or quadriceps tendon autograft; and
• Able to complete rehabilitation at one of the 4 participating TRIA locations.

You may not qualify if:

• Previous ACL injury or surgery to either limb;
• Concomitant ligamentous injury \> Grade II or requiring surgery; and
• Surgical procedure to articular cartilage requiring non-weight-bearing after surgery.

Sponsors & Collaborators

• HealthPartners Institute: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

TRIA

Bloomington, Minnesota, 55431, United States

RECRUITING

MeSH Terms

Interventions

Rehabilitation; Exercise

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

TRIA Research

CONTACT

952-806-5603; TRIAResearch@tria.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 27, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)