Improving ACL Reconstruction Outcomes: CBPT

Not Applicable

Completed

• Conditions: ACL - Anterior Cruciate Ligament Rupture; ACL Sprain; ACL Injury; ACL Tear
• Interventions: Behavioral: CBPT-ACLR; Other: Education

• Registration Number: NCT03243162
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-04
• Study First Posted: 2017-08-08
• Primary Completion: 2020-02-18
• Study Completion: 2020-04-17
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-18
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CBPT-ACLR	CBPT-ACLR	CBPT-ACLR program consisting of weekly phone calls.
Education	Education	Education program consisting of weekly phone calls.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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

Trial Locations

Locations (2)

Cleveland Clinic; 🇺🇸 Garfield Heights, Ohio, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States