Improving ACL Reconstruction Outcomes: CBPT

NCT ID: NCT03243162

Last Updated: 2020-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2020-04-17

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.

Conditions

ACL Injury; ACL - Anterior Cruciate Ligament Rupture; ACL Sprain; ACL Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CBPT-ACLR

CBPT-ACLR program consisting of weekly phone calls.

Group Type: EXPERIMENTAL

CBPT-ACLR

Intervention Type: 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.

Education

Education program consisting of weekly phone calls.

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: 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.

Interventions

CBPT-ACLR

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.

Intervention Type: BEHAVIORAL

Education

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kristin Archer

Associate Professor and Vice Chair of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristin Archer, PhD, DPT

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Cleveland Clinic

Garfield Heights, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

161927

Identifier Type: -

Identifier Source: org_study_id