ACL Reconstruction Rehabilitation With Exercise and Psychological Support

NCT ID: NCT06991192

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-08-31

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.

Detailed Description

The objective of this study is to examine the efficacy of Rehabilitation with Exercise and Psychological Support (REPS), a rehabilitation approach that integrates exercise with psychological support provided by physical therapist and patient training videos. The central hypothesis is that REPS will facilitate better psychological response (Specific Aim 1) and knee function (Specific Aim 2) than Standard Rehabilitation after ACL reconstruction. The feasibility, acceptability, and fidelity of implementing REPS will be explored. This is a pilot randomized controlled trial of 60 patients with ACL reconstruction who receive REPS or Standard Rehabilitation. Study participants in both treatment arms will receive exercise per a standard rehabilitation protocol. Physical therapists providing the REPS intervention will receive didactic training in psychologically informed practice principles and REPS procedures, clinical application practice, and regular feedback from the study team. Study participants in REPS will receive training videos on psychosocial aspects of recovery and mental skills to improve the psychological response. Study visits will occur prior to surgery (baseline), immediately before the first rehabilitation visit post-surgery, 3 months post-surgery, and 6 months post-surgery.

Study Aims Specific Aim 1. To examine the efficacy of REPS on psychological response after ACL reconstruction. Primary Hypothesis: Psychological readiness for sport, measured with the ACL Return to Sport after Injury (ACL-RSI) scale, will be higher in REPS than Standard Rehabilitation at 6 months post-surgery. Secondary Hypothesis: Kinesiophobia, measured with the Tampa Scale for Kinesiophobia (TSK-11) questionnaire, will be lower in REPS than Standard Rehabilitation at 6 months post-surgery.

Specific Aim 2. To examine the efficacy of REPS on knee function after ACL reconstruction. Hypothesis: Self-reported knee function, measured with the International Knee Documentation Committee (IKDC) subjective form, will be higher in REPS than Standard Rehabilitation at 6 months post-surgery.

Exploratory Aim. To assess the feasibility, acceptability, and fidelity of implementing REPS after ACL reconstruction. Research records will be used to assess the feasibility of REPS, and develop surveys for patients and clinicians will be used to assess the acceptability of REPS. In both treatment arms, patients will complete questionnaires that align with anticipated clinical changes in empathy (Consultation and Relational Empathy, CARE) and therapeutic alliance (Working Alliance Inventory-Short Revised, WAI-SR), and documentation templates will be used to record treatments and training for descriptive analysis of fidelity.

Conditions

Anterior Cruciate Ligament Reconstruction Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard Rehabilitation

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Psychological Support (REPS)

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.

Group Type: EXPERIMENTAL

Rehabilitation with Exercise and Psychological Support (REPS)

Intervention Type: 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.

Interventions

Rehabilitation with Exercise and Psychological Support (REPS)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Locations

TRIA

Bloomington, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

TRIA Research

Role: CONTACT

TRIAResearch@tria.com

952-806-5603

Facility Contacts

Andrea Lange

Role: primary

TRIAResearch@tria.com

952-806-5603

Other Identifiers

R21AR082572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A23-019

Identifier Type: -

Identifier Source: org_study_id