Occupational/Physical Therapy to Reduce Morbidity Post-Operative Bilateral Breast Reconstruction
NCT02203669 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2023-05-23
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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