Improving ACL Reconstruction Outcomes: CBPT
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|ClinicalTrials.gov Identifier: NCT03243162|
Recruitment Status : Completed
First Posted : August 8, 2017
Last Update Posted : May 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|ACL Injury ACL - Anterior Cruciate Ligament Rupture ACL Sprain ACL Tear||Behavioral: CBPT-ACLR Other: Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Improving ACL Reconstruction Outcomes: Cognitive-Behavioral Based Physical Therapy|
|Actual Study Start Date :||July 1, 2017|
|Actual Primary Completion Date :||February 18, 2020|
|Actual Study Completion Date :||April 17, 2020|
CBPT-ACLR program consisting of weekly phone calls.
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.
Active Comparator: Education
Education program consisting of weekly phone calls.
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 Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale [ Time Frame: Up to 12 months after ACLR surgery ]knee function relating to sport/recreation
- Marx Activity Rating Scale [ Time Frame: Up to 12 months after ACLR surgery ]The Marx Activity Rating Scale measures knee function relating to running, cutting, decelerating, and pivoting.
- Subjective Patient Outcome for Return to Sports (SPORTS) [ Time Frame: 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 [ Time Frame: Up to 12 months after ACLR surgery ]knee function relating to quality of life
- EQ-5D [ Time Frame: Up to 12 months after ACLR surgery ]The EQ-5D is used to measure non-disease-specific quality of life and calculate cost-effectiveness.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243162
|United States, Ohio|
|Garfield Heights, Ohio, United States, 44125|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Kristin Archer, PhD, DPT||Vanderbilt University Medical Center|