ACL - Anterior Cruciate Ligament Rupture, ACL Injury, ACL Sprain, ACL Tear
Conditions
Brief summary
The overall objective of this study is to conduct a two-group randomized trial to examine the efficacy of cognitive-behavioral based physical therapy (CBPT) for improving knee function, return to sport, and quality of life outcomes in patients following ACL reconstruction (ACLR). The study consists of two treatment groups: telephone-based cognitive-behavioral based physical therapy for ACLR (CBPT-ACLR) and telephone-based Education. The central hypothesis is that the CBPT-ACLR participants relative to the Education group will demonstrate significantly greater improvement in postoperative outcomes at 12 months following surgery.
Interventions
BEHAVIORALCBPT-ACLR
The CBPT-ACLR program focuses on improving sports function and return to sport. CBPT-ACLR sessions cover realistic expectations, relaxation strategies, problem-solving training, cognitive restructuring, and behavioral self-management (i.e., graded activity, goal setting, managing setbacks and symptom management plans). Each session builds upon the content of the previous session using an action plan and weekly homework is personally tailored based on patient goals. The program consists of one preoperative telephone session and six postoperative telephone sessions with a physical therapist. Each patient randomized into the CBPT-ACLR program will receive a manual to follow along with the study therapist.
OTHEREducation
The education program focuses on postoperative ACLR recovery. Sessions address benefits of physical therapy, proper biomechanics during sports and other functional activity, importance of early exercise after surgery, and ways to promote healing. Education on stress reduction, sleep hygiene, energy management, communication with health providers, and preventing future injury are also provided. The Education program is matched to the CBPT-ACLR treatment in terms of session frequency, length and contact with the study therapist. Each patient randomized into the Education program will receive a manual to follow along with the study therapist.
Sponsors
The Cleveland Clinic
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
14 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. English speaking (due to feasibility of employing study personnel to deliver and assess the study intervention); 2. 14 to 35 years of age (children 14 and older have skeletal maturity and adults 35 and younger are less likely to have symptoms of knee osteoarthritis); 3. no previous surgery to either knee; 4. time from injury to surgery 12 months or less; 5. active participation in a sport on a weekly basis prior to injury
Exclusion criteria
1. bilateral simultaneous ACL reconstructions; 2. revision ACLR; 3. any concurrent ligament (MCL, LCL, or PCL) surgical procedures; 4. concurrent osteotomies or meniscus transplantations; 5. surgery secondary to trauma, tumor, or infection; 6. having workman's compensation insurance for surgery; 7. on active military duty; 8. medical history of schizophrenia or other psychotic disorder; and 9. unable to provide stable address and access to a telephone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale | Up to 12 months after ACLR surgery | knee function relating to sport/recreation |
| Marx Activity Rating Scale | Up to 12 months after ACLR surgery | The Marx Activity Rating Scale measures knee function relating to running, cutting, decelerating, and pivoting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Patient Outcome for Return to Sports (SPORTS) | Up to 12 months after ACLR surgery | The SPORTS score measures 1) ability to perform the same sport with the same level of effort, 2) ability to reach the same level of performance, and 3) ability to perform with no pain or in spite of the pain. |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life sub-scale | Up to 12 months after ACLR surgery | knee function relating to quality of life |
| EQ-5D | Up to 12 months after ACLR surgery | The EQ-5D is used to measure non-disease-specific quality of life and calculate cost-effectiveness. |
Countries
United States
Outcome results
None listed