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

NCT02203669 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-05-23

No results posted yet for this study

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.

Conditions

  • Occupational/Physical Therapy
  • Post-operative Breast Reconstruction

Interventions

OTHER

Home therapy

Study subjects complete home therapy independently for four (4) weeks based on handouts of exercises adapted for post-operative breast reconstruction patients along with an instructional handout for stretching complied by a certified occupational therapist.

OTHER

Structured In-Office Therapy

Study subjects will participate in Structured In-Office Therapy twice a week for four (4) weeks. Each visit will last approximately sixty (60) minutes. Subjects will receive therapy instruction by a certified occupational therapist on upper extremity stretching, relaxation, cardio rehabilitation, and strength training. These subjects will also receive exercise and stretching handouts to use at home between therapy visits.

Sponsors & Collaborators

  • University of Tennessee

    lead OTHER

Principal Investigators

  • Mark Brzezienski, MD · The University of Tennessee

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-05-31
Completion
2015-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02203669 on ClinicalTrials.gov