ACL Reconstruction Rehabilitation With Exercise and Psychological Support

ConditionAnterior Cruciate Ligament Reconstruction Rehabilitation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age15-25

SponsorHealthPartners Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Standard RehabilitationNo intervention 0 interventions

Group B: Psychological Support (REPS)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

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

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.

Time frame

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

Secondary outcomes

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.

Time frame

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).

Time frame

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).

Time frame

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 \[(surgical limb measure/non-surgical limb measure) \* 100\].

Time frame

3-months and 6-months post-surgery

Other outcomes

Feasibility: Enrollment Rate

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.

Time frame

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

Feasibility: Drop-out Rate

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.

Time frame

From enrollment to 6-months post-surgery

Acceptability: REPS Patient Experience

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.

Time frame

6-months post-surgery

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

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.

Time frame

3-months and 6-months post-surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HealthPartners Institute

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov

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