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Improving ACL Reconstruction Outcomes: CBPT

Primary Purpose

ACL Injury, ACL - Anterior Cruciate Ligament Rupture, ACL Sprain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBPT-ACLR
Education
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ACL Injury

Eligibility Criteria

14 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBPT-ACLR

Education

Arm Description

CBPT-ACLR program consisting of weekly phone calls.

Education program consisting of weekly phone calls.

Outcomes

Primary Outcome Measures

Knee Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale
knee function relating to sport/recreation
Marx Activity Rating Scale
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)
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
knee function relating to quality of life
EQ-5D
The EQ-5D is used to measure non-disease-specific quality of life and calculate cost-effectiveness.

Full Information

First Posted
August 4, 2017
Last Updated
May 18, 2020
Sponsor
Vanderbilt University Medical Center
Collaborators
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03243162
Brief Title
Improving ACL Reconstruction Outcomes: CBPT
Official Title
Improving ACL Reconstruction Outcomes: Cognitive-Behavioral Based Physical Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
February 18, 2020 (Actual)
Study Completion Date
April 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury, ACL - Anterior Cruciate Ligament Rupture, ACL Sprain, ACL Tear

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBPT-ACLR
Arm Type
Experimental
Arm Description
CBPT-ACLR program consisting of weekly phone calls.
Arm Title
Education
Arm Type
Active Comparator
Arm Description
Education program consisting of weekly phone calls.
Intervention Type
Behavioral
Intervention Name(s)
CBPT-ACLR
Intervention Description
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
Other
Intervention Name(s)
Education
Intervention Description
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 Outcome Measure Information:
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS) sport and recreation sub-scale
Description
knee function relating to sport/recreation
Time Frame
Up to 12 months after ACLR surgery
Title
Marx Activity Rating Scale
Description
The Marx Activity Rating Scale measures knee function relating to running, cutting, decelerating, and pivoting.
Time Frame
Up to 12 months after ACLR surgery
Secondary Outcome Measure Information:
Title
Subjective Patient Outcome for Return to Sports (SPORTS)
Description
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.
Time Frame
Up to 12 months after ACLR surgery
Title
Knee Injury and Osteoarthritis Outcome Score (KOOS) knee related quality of life sub-scale
Description
knee function relating to quality of life
Time Frame
Up to 12 months after ACLR surgery
Title
EQ-5D
Description
The EQ-5D is used to measure non-disease-specific quality of life and calculate cost-effectiveness.
Time Frame
Up to 12 months after ACLR surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Archer, PhD, DPT
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Garfield Heights
State/Province
Ohio
ZIP/Postal Code
44125
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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Improving ACL Reconstruction Outcomes: CBPT

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