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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Occupational/Physical Therapy Post-operative Breast Reconstruction Other: Home therapy Other: Structured In-Office Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Tennessee
The Plastic Surgery Group, P.C.
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
University of Tennessee
Investigators
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Principal Investigator: Mark Brzezienski, MD The University of Tennessee
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Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT02203669    
Other Study ID Numbers: OTPT2014
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: July 30, 2014
Last Verified: July 2014
Keywords provided by University of Tennessee:
breast reconstruction
occupational therapy
physical therapy
upper extremity morbidity