Occupational/Physical TherapyNCT02203669
Occupational/Physical Therapy to Reduce Morbidity Post-Operative Bilateral Breast Reconstruction
A study testing Home therapy and Structured In-Office Therapy in people with Occupational/Physical Therapy and Post-operative Breast Reconstruction, run by University of Tennessee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Occupational/Physical Therapy, Post-operative Breast Reconstruction
- What is being tested?
- Home therapy and Structured In-Office Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women undergoing unilateral breast reconstruction
- Unable to provide informed consent in English
- Physically unable to engage in the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
The Plastic Surgery Group, P.C.
Chattanooga, Tennessee, 37403
About this study
Official title: The Use of Occupational/Physical Therapy to Reduce Upper Extremity Morbidity Post-Operative Bilateral Breast Reconstruction
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.
- Being tested
- Home therapy, Structured In-Office Therapy
- Keywords
- breast reconstruction, occupational therapy, physical therapy, upper extremity morbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home therapyOther
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.
Structured In-Office TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Structured In-Office Therapy | Active comparator | 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. Receives: Other: Structured In-Office Therapy |
| No therapy | No intervention | Study subjects in this arm will not receive post-operative occupational /physical therapy. Will complete the DASH at week 1 and week 4. |
| Home Therapy | Active comparator | 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. Receives: Other: Home therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DASH: Disabilities of the Arm, Shoulder and Hand score
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.
Measured: Week 1 and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2015 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: Never did begin
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational/Physical TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Brzezienski, MD, Principal investigator, The University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02203669
- Sponsor's protocol ID
- OTPT2014
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2014
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Occupational/Physical Therapy to Reduce Upper Extremity Morbidity Post-Operative Bilateral Breast Reconstruction
- ClinicalTrials.gov ID
- NCT02203669
- Acronym / sponsor ID
- OTPT2014
- Keywords
- breast reconstruction, occupational therapy, physical therapy, upper extremity morbidity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Never did begin
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- May 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Structured In-Office Therapy | Active comparator | Other: Structured In-Office TherapyStructured 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. |
| No therapy | No intervention | –Study subjects in this arm will not receive post-operative occupational /physical therapy. Will complete the DASH at week 1 and week 4. |
| Home Therapy | Active comparator | Other: Home therapyHome 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Women undergoing unilateral breast reconstruction
- Unable to provide informed consent in English
- Physically unable to engage in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home therapyStudy 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 | Home Therapy |
| Structured In-Office TherapyStudy 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. | Other | Structured In-Office Therapy |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Brzezienski, MD principal investigator
The University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home therapy and Structured In-Office Therapy in people with Occupational/Physical Therapy and Post-operative Breast Reconstruction, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DASH: Disabilities of the Arm, Shoulder and Hand score (time frame: Week 1 and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.