Improving ACL Reconstruction Outcomes: CBPT

Sponsor

Vanderbilt University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT03243162

Collaborator

The Cleveland Clinic (Other)

Enrollment

Locations

Arms

33.5

Actual Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ACL Injury ACL - Anterior Cruciate Ligament Rupture ACL Sprain ACL Tear	Behavioral: CBPT-ACLR Other: Education	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Improving ACL Reconstruction Outcomes: Cognitive-Behavioral Based Physical Therapy

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Feb 18, 2020

Actual Study Completion Date :

Apr 17, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Knee Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale [Up to 12 months after ACLR surgery]
knee function relating to sport/recreation
Marx Activity Rating Scale [Up to 12 months after ACLR surgery]
The Marx Activity Rating Scale measures knee function relating to running, cutting, decelerating, and pivoting.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Garfield Heights	Ohio	United States	44125
2	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232

Sponsors and Collaborators

Vanderbilt University Medical Center
The Cleveland Clinic

Investigators

Principal Investigator: Kristin Archer, PhD, DPT, Vanderbilt University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kristin Archer, Associate Professor and Vice Chair of Research, Vanderbilt University Medical Center

ClinicalTrials.gov Identifier:

NCT03243162

Other Study ID Numbers:

161927

First Posted:

Aug 8, 2017

Last Update Posted:

May 20, 2020

Last Verified:

May 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rupture

Anterior Cruciate Ligament Injuries

Study Results

No Results Posted as of May 20, 2020