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Improving ACL Reconstruction Outcomes: CBPT

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ClinicalTrials.gov Identifier: NCT03243162
Recruitment Status : Completed
First Posted : August 8, 2017
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Kristin Archer, Vanderbilt University Medical Center

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : July 1, 2017
Actual Primary Completion Date : February 18, 2020
Actual Study Completion Date : April 17, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   14 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243162


Locations
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United States, Ohio
Cleveland Clinic
Garfield Heights, Ohio, United States, 44125
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University Medical Center
The Cleveland Clinic
Investigators
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Principal Investigator: Kristin Archer, PhD, DPT Vanderbilt University Medical Center
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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: August 8, 2017    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rupture
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries