Occupational/Physical Therapy to Reduce Morbidity Post-Operative Bilateral Breast Reconstruction
|ClinicalTrials.gov Identifier: NCT02203669|
Recruitment Status : Unknown
Verified July 2014 by University of Tennessee.
Recruitment status was: Enrolling by invitation
First Posted : July 30, 2014
Last Update Posted : July 30, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Occupational/Physical Therapy Post-operative Breast Reconstruction||Other: Home therapy Other: Structured In-Office Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Use of Occupational/Physical Therapy to Reduce Upper Extremity Morbidity Post-Operative Bilateral Breast Reconstruction|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||May 2015|
|Estimated Study Completion Date :||June 2015|
Active Comparator: 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.
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.
No Intervention: No therapy
Study subjects in this arm will not receive post-operative occupational /physical therapy. Will complete the DASH at week 1 and week 4.
Active Comparator: 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.
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.
- Change in DASH: Disabilities of the Arm, Shoulder and Hand score [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203669
|United States, Tennessee|
|The Plastic Surgery Group, P.C.|
|Chattanooga, Tennessee, United States, 37403|
|Principal Investigator:||Mark Brzezienski, MD||The University of Tennessee|