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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBPT-ACLR | Experimental | CBPT-ACLR program consisting of weekly phone calls. |
|
| Education | Active Comparator | Education program consisting of weekly phone calls. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBPT-ACLR | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale | knee function relating to sport/recreation | Up to 12 months after ACLR surgery |
| Marx Activity Rating Scale | The Marx Activity Rating Scale measures knee function relating to running, cutting, decelerating, and pivoting. | Up to 12 months after ACLR surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Patient Outcome for Return to Sports (SPORTS) | 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. | Up to 12 months after ACLR surgery |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life sub-scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Archer, PhD, DPT | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Garfield Heights | Ohio | 44125 | United States | ||
| Vanderbilt University Medical Center |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| Education | Other | 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. |
|
knee function relating to quality of life |
| Up to 12 months after ACLR surgery |
| EQ-5D | The EQ-5D is used to measure non-disease-specific quality of life and calculate cost-effectiveness. | Up to 12 months after ACLR surgery |
| Nashville |
| Tennessee |
| 37232 |
| United States |