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NCT Number: NCT06991192

ACL Reconstruction Rehabilitation With Exercise and Psychological Support

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.

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Key information

Age range

15 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. ACL Return to Sport after Injury (ACL-RSI)

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

    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.

  2. International Knee Documentation Committee (IKDC) Subjective Form

    Time frame: 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 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.

Secondary outcomes

  1. Tampa Scale for Kinesiophobia (TSK-11)

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

    TSK-11 has 11-items on kinesiophobia, or pain-related fear of movement/re-injury. Scores range from 11 to 44 points, and higher scores indicate greater kinesiophobia. TSK-11 has demonstrated validity for patients with ACL reconstruction.

  2. Clinical Test (Knee pain)

    Time frame: 3-months and 6-months post-surgery

    The Numeric Pain Rating Scale (NPRS) will be used to assess pain at rest and pain with a countermovement jump, if applicable. The scale ranges from 0 (no pain) to 10 (highest imaginable pain).

  3. Clinical Test (Knee range of motion)

    Time frame: 3-months and 6-months post-surgery

    Knee range of motion (flexion and extension) will be assessed bilaterally in a supine position with a goniometer. Interlimb symmetry will be computed as (non-surgical knee motion - surgical knee motion).

  4. Clinical Test (Quadriceps strength)

    Time frame: 3-months and 6-months post-surgery

    Isometric quadriceps strength will be measured bilaterally on an isokinetic dynamometer (CSMi Solutions, Stoughton, MA) with the knee in 60° of flexion. Peak knee extensor torque (N-m) from 3 trials will be recorded. The interlimb symmetry index for isometric quadriceps strength will be computed as [(surgical limb measure/non-surgical limb measure) * 100].

  5. Clinical Test (Countermovement jump)

    Time frame: 6-months post-surgery

    If the study participant meets clinical criteria, a countermovement jump will be performed on a force platform (Hawkin Dynamics, Westbrook, ME). Jump height, bilateral braking impulse index, bilateral propulsion impulse index, modified reaction strength index and landing stiffness will be recorded.

  6. Clinical Test (Single leg hop battery)

    Time frame: 6-months post surgery

    Single leg hop testing will include three hop tests: single hop, triple crossover hop, and lateral timed hop. Subjects will receive verbal instruction and visual demonstration followed by 1 or more practice trials. Subjects will then perform three test trials on each leg, and the best performance (distance or time) will be recorded and expressed as a percentage (involved/uninvolved x 100). This outcome will be calculated as the average limb symmetry index across the three tests with scores ranging from 0 to 100. Higher scores reflect better symmetry and increased function.

  7. Clinical Test (Squat test)

    Time frame: 3-months post-surgery

    Patient will stand on a force plate and perform a squat. Two trials will be collected and two metrics will be reported Left/right average force asymmetry (%) and Left/right peak force asymmetry (%).

Other outcomes

  1. Feasibility: Enrollment Rate

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

    Feasibility of implementing REPS after ACL reconstruction will be measured by calculating the percentage of patients who enrolled in the trial from the number screened for eligibility. This will be reported as a single point estimate with the denominator being the number of patients screened, larger than the sample size used for other outcome measures.

  2. Feasibility: Drop-out Rate

    Time frame: From enrollment to 6-months post-surgery

    Feasibility of of implementing REPS after ACL reconstruction will be measured by calculating the percentage of enrolled patients who withdraw from the study before the end of the intervention period.

  3. Acceptability: REPS Patient Experience

    Time frame: 6-months post-surgery

    Patient reported acceptability of implementing REPS after ACL reconstruction will be assessed from responses to the question "I like learning about how my mind responds to my injury" as part of the 6-month post-surgery REPS patient experience survey. The percentage of REPS intervention patients who report either "Strongly agree" or "Somewhat agree" will be reported. This outcome will only be measured in patient randomized to the REPS study arm.

  4. Fidelity (Receipt): Consultation and Relational Empathy (CARE)

    Time frame: 3-months and 6-months post-surgery

    The Consultation and Relational Empathy (CARE) measure is a 10-item patient-assessed questionnaire that captures empathetic support provided for patients in clinical and general medical settings. Items assess how well the patient felt their doctor listened, was positive and compassionate. CARE scores range from 1 to 50 points, and higher scores indicate higher empathy in the consultation process.

  5. Fidelity (Receipt): Working Alliance Inventory-Short Revised (WAI-SR)

    Time frame: 3-months and 6-months post-surgery

    The Working Alliance Inventory-Short Revised (WAI-SR) measure is a 12-item patient-assessed questionnaire that captures key aspect of the therapeutic alliance. WAI-SR scores range from 15 to 60 points, and higher scores indicate stronger therapeutic alliance.

  6. Fidelity (Delivery): Rehabilitation Dose

    Time frame: From initial rehabilitation visit to 6-months post-surgery

    Delivery of patient training will be measured throughout the post-surgery period via proportion of scheduled visits attended. The average attendance will be summarized from treatment documentation templates in the electronic medical record at 6 months post-surgery and calculated separately for the REPS and comparison arms.

Study contacts

Contact information is provided by the study sponsor or research team.

TRIA Research

CONTACT

[email protected]

952-806-5603

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

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

Registry information

Acronym: ACLR-REPS

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 27, 2025
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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