Clinical trial NCT06991192: ACL Reconstruction Rehabilitation With Exercise and Psychological Support
Official title: ACL Reconstruction Rehabilitation With Exercise and Psychological Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction Rehabilitation
Keywords: ACL Reconstruction
Anterior Cruciate Ligament
Rehabilitation
Psychological
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2025-05-27
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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; and
* Able to complete rehabilitation at TRIA Gameface location.

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.

Primary outcomes:
measure: ACL Return to Sport after Injury (ACL-RSI)
timeFrame: Pre-surgery (baseline), prior to first post-surgical rehabilitation visit , 3-months post-surgery, 6-months post-surgery
measure: International Knee Documentation Committee (IKDC) Subjective Form
timeFrame: Pre-surgery (baseline), prior to first post-surgical rehabilitation visit , 3-months post-surgery, 6-months post-surgery
Secondary outcomes:
measure: Tampa Scale for Kinesiophobia (TSK-11)
timeFrame: Pre-surgery (baseline), prior to first post-surgical rehabilitation visit , 3-months post-surgery, 6-months post-surgery
measure: Clinical Test (Knee pain)
timeFrame: 3-months and 6-months post-surgery
measure: Clinical Test (Knee range of motion)
timeFrame: 3-months and 6-months post-surgery
measure: Clinical Test (Quadriceps strength)
timeFrame: 3-months and 6-months post-surgery
measure: Clinical Test (Countermovement jump)
timeFrame: 3-months (if applicable) and 6-months post-surgery
measure: Clinical Test (Single leg hop battery)
timeFrame: 6-months post surgery
Other outcomes:
measure: Feasibility: Enrollment Rate
timeFrame: From the date when study enrollment was initiated until the last study participant is enrolled, up to 24 months
measure: Feasibility: Drop-out Rate
timeFrame: From enrollment to 6-months post-surgery
measure: Acceptability: REPS Patient Experience
timeFrame: 6-months post-surgery
measure: Fidelity (Receipt): Consultation and Relational Empathy (CARE)
timeFrame: 3-months and 6-months post-surgery
measure: Fidelity (Receipt): Working Alliance Inventory-Short Revised (WAI-SR)
timeFrame: 3-months and 6-months post-surgery
measure: Fidelity (Delivery): Rehabilitation Dose
timeFrame: From initial rehabilitation visit to 6-months post-surgery
Locations:
city: Bloomington
country: United States
facility: TRIA
state: Minnesota
Study officials:
References: