ACL Reconstruction Rehabilitation With Exercise and Psychological Support (ACLR-REPS)

HealthPartners Institute

Status: Enrolling

Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation

Treatments: Behavioral: Rehabilitation with Exercise and Psychological Support (REPS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06991192

A23-019

R21AR082572 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 15 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Standard Rehabilitation

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Rehabilitation with Exercise and Psychological Support (REPS)