Clinical trial NCT03243162: Improving ACL Reconstruction Outcomes: CBPT
Official title: Improving ACL Reconstruction Outcomes: Cognitive-Behavioral Based Physical Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACL Injury
ACL - Anterior Cruciate Ligament Rupture
ACL Sprain
ACL Tear
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
First posted: 2017-08-08
Enrollment: 90
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale
timeFrame: Up to 12 months after ACLR surgery
measure: Marx Activity Rating Scale
timeFrame: Up to 12 months after ACLR surgery
Secondary outcomes:
measure: Subjective Patient Outcome for Return to Sports (SPORTS)
timeFrame: Up to 12 months after ACLR surgery
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life sub-scale
timeFrame: Up to 12 months after ACLR surgery
measure: EQ-5D
timeFrame: Up to 12 months after ACLR surgery
Other outcomes:
Locations:
city: Garfield Heights
country: United States
facility: Cleveland Clinic
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Kristin Archer, PhD, DPT
role: PRINCIPAL_INVESTIGATOR
References: