Improving ACL Reconstruction Outcomes: Cognitive-Behavioral Based Physical Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ACL Injury
- Sponsor
- Vanderbilt University Medical Center
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Knee Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Kristin Archer
Associate Professor and Vice Chair of Research
Vanderbilt University Medical Center
Eligibility Criteria
Inclusion Criteria
- •English speaking (due to feasibility of employing study personnel to deliver and assess the study intervention);
- •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);
- •no previous surgery to either knee;
- •time from injury to surgery 12 months or less;
- •active participation in a sport on a weekly basis prior to injury
Exclusion Criteria
- •bilateral simultaneous ACL reconstructions;
- •revision ACLR;
- •any concurrent ligament (MCL, LCL, or PCL) surgical procedures;
- •concurrent osteotomies or meniscus transplantations;
- •surgery secondary to trauma, tumor, or infection;
- •having workman's compensation insurance for surgery;
- •on active military duty;
- •medical history of schizophrenia or other psychotic disorder; and
- •unable to provide stable address and access to a telephone
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- EQ-5D(Up to 12 months after ACLR surgery)
- Subjective Patient Outcome for Return to Sports (SPORTS)(Up to 12 months after ACLR surgery)
- Knee Injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life sub-scale(Up to 12 months after ACLR surgery)