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

Not Applicable

Withdrawn

• Conditions: Occupational/Physical Therapy; Post-operative Breast Reconstruction
• Interventions: Other: Home therapy; Other: Structured In-Office Therapy

• 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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
Home Therapy	Home therapy	Home Therapy: Study subjects will receive a handout of exercises adapted for post-operative breast reconstruction patients along with an instructional handout for stretching complied by a certified occupational therapist to complete independently at home for four (4) weeks. Will complete the DASH at week 1 and week 4.
Structured In-Office Therapy	Structured In-Office Therapy	Structured In-Office Therapy: Study subjects will receive structured, therapist-supervised occupational/physical therapy twice per week for four (4) weeks. Each visit will last approximately sixty (60) minutes. Patients in this arm will receive therapy instruction by a certified occupational therapist on upper extremity stretching, relaxation, cardio rehabilitation, and strength training. These patients will also receive exercise and stretching handouts to use at home between therapy visits. Will complete the DASH at week 1 and week 4.

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