Occupational/Physical Therapy to Reduce Morbidity Post-Operative Bilateral Breast Reconstruction

Not Applicable

Withdrawn

• Conditions: Occupational/Physical Therapy; Post-operative Breast Reconstruction

• Registration Number: NCT02203669
• Lead Sponsor: University of Tennessee

Brief Summary

The purpose of this study is to demonstrate the benefits of a structured occupational/physical therapy program on upper extremity morbidity for patients who have received bilateral breast reconstruction in comparison to a home therapy program and no post-operative therapy.

Hypothesis: Patients who engage in therapist-supervised occupational therapy following bilateral breast reconstruction have less upper extremity morbidity than those patients who complete a home therapy program or no therapy program.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-07
• Study Start: 2014-07
• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-30
• Primary Completion: 2015-05
• Study Completion: 2015-06
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Age ≥ 18 years of age
• Women who have had bilateral breast reconstruction
• All cancer stages will be included
• Physically and mentally able to participate in the study within the required time-frame
• Able to voluntarily give full informed consent to participate in the study

Exclusion Criteria

• Women undergoing unilateral breast reconstruction
• Unable to provide informed consent in English
• Physically unable to engage in the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in DASH: Disabilities of the Arm, Shoulder and Hand score	Week 1 and Week 4	A change in DASH score will be calculated. The DASH: Disabilities of the Arm, Shoulder, and Hand (Appendix D) questionnaire will be utilized to measure physical function and symptoms of the upper limbs. The DASH consists of 30-items to be self-reported by the patient: physical function twenty-one (21) items, pain symptoms five (5) items, and emotional and social function four (4) items. The result of the DASH is a numerical disability score ranging from zero to one hundred (0-100), with zero (0) being no disability and one hundred (100) being the most severe disability.

Trial Locations

Locations (1)

The Plastic Surgery Group, P.C.; 🇺🇸 Chattanooga, Tennessee, United States