An interventional study of CBPT-ACLR and Education in ACL Injury, ACL - Anterior Cruciate Ligament Rupture and ACL Sprain, sponsored by Vanderbilt University Medical Center. Completed at 2 sites in United States. Open to participants aged 14 Years to 35 Years. Per ClinicalTrials.gov, last updated 2020-05-20.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
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.
557 studies on the registry are indexed under Rupture; 97 are open to participants now.
This study's enrollment of 90 is above the median of 72 across 334 interventional studies indexed under Rupture.
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Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
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Exclusion Criteria:
CBPT-ACLR program consisting of weekly phone calls.
Behavioral: CBPT-ACLR
Education program consisting of weekly phone calls.
Other: Education
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.
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
knee function relating to sport/recreation
Time frame: 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.
Time frame: Up to 12 months after ACLR surgery
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.
Time frame: Up to 12 months after ACLR surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life sub-scale
knee function relating to quality of life
Time frame: 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.
Time frame: Up to 12 months after ACLR surgery
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Vanderbilt University Medical Center