Trials / Completed
CompletedNCT03243162
Improving ACL Reconstruction Outcomes: CBPT
Improving ACL Reconstruction Outcomes: Cognitive-Behavioral Based Physical Therapy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Vanderbilt University Medical Center · Academic / Other
- Sex
- All
- Age
- 14 Years – 35 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2017-07-01
- Primary completion
- 2020-02-18
- Completion
- 2020-04-17
- First posted
- 2017-08-08
- Last updated
- 2020-05-20
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03243162. Inclusion in this directory is not an endorsement.