Improving ACL Reconstruction Outcomes: CBPT

Improving ACL Reconstruction Outcomes: Cognitive-Behavioral Based Physical Therapy

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.

Study Overview

• Status: Completed
• Conditions: ACL Injury; ACL Tear; ACL - Anterior Cruciate Ligament Rupture; ACL Sprain
• Intervention / Treatment: Behavioral: CBPT-ACLR; Other: Education

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Garfield Heights, Ohio, United States, 44125
      • Cleveland Clinic
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 35 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: CBPT-ACLR; CBPT-ACLR program consisting of weekly phone calls.	Behavioral: 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.
ACTIVE_COMPARATOR: Education; Education program consisting of weekly phone calls.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Patient Outcome for Return to Sports (SPORTS)	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.	Up to 12 months after ACLR surgery
Knee Injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life sub-scale	knee function relating to quality of life	Up to 12 months after ACLR surgery
EQ-5D	The EQ-5D is used to measure non-disease-specific quality of life and calculate cost-effectiveness.	Up to 12 months after ACLR surgery

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: The Cleveland Clinic
• Investigators: Principal Investigator: Kristin Archer, PhD, DPT, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2017
• Primary Completion (ACTUAL): February 18, 2020
• Study Completion (ACTUAL): April 17, 2020

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (ACTUAL): August 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Rupture; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 161927

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No