Occupational/Physical Therapy, Post-operative Breast Reconstruction
Conditions
Keywords
breast reconstruction, occupational therapy, physical therapy, upper extremity morbidity
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.
Interventions
OTHERHome 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.
OTHERStructured 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
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed