Improving ACL Reconstruction Outcomes: CBPT

NCT03243162 | Completed

• 1 other identifier: 161927
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Knee Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale

  knee function relating to sport/recreation

  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.

  Up to 12 months after ACLR surgery

Secondary Outcomes (3)

• 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

• EQ-5D

  Up to 12 months after ACLR surgery

Study Arms (2)

CBPT-ACLR

EXPERIMENTAL

CBPT-ACLR program consisting of weekly phone calls.

Behavioral: CBPT-ACLR

Education

ACTIVE COMPARATOR

Education program consisting of weekly phone calls.

Other: Education

Interventions

CBPT-ACLR 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.

CBPT-ACLR

Education 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.

Education

Eligibility Criteria

• Age: 14 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• English speaking (due to feasibility of employing study personnel to deliver and assess the study intervention);
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• The Cleveland Clinic: collaborator

Study Sites (2)

Cleveland Clinic

Garfield Heights, Ohio, 44125, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Kristin Archer, PhD, DPT

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Vice Chair of Research

Study Record Dates

• First Submitted: August 4, 2017
• First Posted: August 8, 2017
• Study Start: July 1, 2017
• Primary Completion: February 18, 2020
• Study Completion: April 17, 2020
• Last Updated: May 20, 2020

Record last verified: 2020-05

Locations

US (2)