Skip to main content
OpenTrials
Completed

NCT Number: NCT03243162

Improving ACL Reconstruction Outcomes: CBPT

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ACL Injury ACL - Anterior Cruciate Ligament Rupture ACL Sprain ACL Tear Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

14 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic, Garfield Heights, Ohio, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  2. 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

  1. Subjective Patient Outcome for Return to Sports (SPORTS)

    Time frame: Up to 12 months after ACLR surgery

    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.

  2. Knee Injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life sub-scale

    Time frame: Up to 12 months after ACLR surgery

    knee function relating to quality of life

  3. EQ-5D

    Time frame: Up to 12 months after ACLR surgery

    The EQ-5D is used to measure non-disease-specific quality of life and calculate cost-effectiveness.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • The Cleveland Clinic

Registry information

Official study title

Improving ACL Reconstruction Outcomes: Cognitive-Behavioral Based Physical Therapy

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 8, 2017
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.