Anterior Cruciate Ligament Reconstruction RehabilitationACLR-REPSNCT06991192
ACL Reconstruction Rehabilitation With Exercise and Psychological Support
A study testing Rehabilitation with Exercise and Psychological Support (REPS) in people with Anterior Cruciate Ligament Reconstruction Rehabilitation, run by HealthPartners Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Anterior Cruciate Ligament Reconstruction Rehabilitation
- What is being tested?
- Rehabilitation with Exercise and Psychological Support (REPS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 15 to 25 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
TRIA
Bloomington, Minnesota, 55431
Andrea Lange, 952-806-5603, TRIAResearch@tria.com
About this study
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.
Read the 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.
- Being tested
- Rehabilitation with Exercise and Psychological Support (REPS)
- Keywords
- ACL Reconstruction, Anterior Cruciate Ligament, Rehabilitation, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation with Exercise and Psychological Support (REPS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Rehabilitation with Exercise and Psychological Support (REPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: Pre-surgery (baseline), prior to first post-surgical rehabilitation visit , 3-months post-surgery, 6-months post-surgery
Clinical Test (Knee pain)
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).
Measured: 3-months and 6-months post-surgery
Clinical Test (Knee range of motion)
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).
Measured: 3-months and 6-months post-surgery
Clinical Test (Quadriceps strength)
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].
Measured: 3-months and 6-months post-surgery
Clinical Test (Countermovement jump)
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.
Measured: 6-months post-surgery
Clinical Test (Single leg hop battery)
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.
Measured: 6-months post surgery
Clinical Test (Squat test)
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 (%).
Measured: 3-months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2025
- Study start1 May 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament Reconstruction RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991192
- Sponsor's protocol ID
- A23-019
- Other IDs
- R21AR082572
- Acronym
- ACLR-REPS
- Status last verified
- Sep 2026
- First submitted
- 21 Apr 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACL Reconstruction Rehabilitation With Exercise and Psychological Support
- ClinicalTrials.gov ID
- NCT06991192
- Acronym / sponsor ID
- ACLR-REPS / A23-019
- Keywords
- ACL Reconstruction, Anterior Cruciate Ligament, Rehabilitation, Psychological
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Rehabilitation with Exercise and 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. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Age 15 to 25 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Psychological Support (REPS) |
Primary outcome
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.
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.
7 secondary outcomes
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
Clinical Test (Knee pain)
Time frame: 3-months and 6-months post-surgery
Clinical Test (Knee range of motion)
Time frame: 3-months and 6-months post-surgery
Clinical Test (Quadriceps strength)
Time frame: 3-months and 6-months post-surgery
Clinical Test (Countermovement jump)
Time frame: 6-months post-surgery
Clinical Test (Single leg hop battery)
Time frame: 6-months post surgery
Clinical Test (Squat test)
Time frame: 3-months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation with Exercise and Psychological Support (REPS) in people with Anterior Cruciate Ligament Reconstruction Rehabilitation, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TRIA Research (952-806-5603, TRIAResearch@tria.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.