- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02332161
Leg Function and ADL After ALT Reconstruction for Head and Neck Cancer
Does Harvesting an Anterolateral Thigh (ALT) Flap Impact Lower Extremity Function and Activities of Daily Living (ADL) in Patients Undergoing Reconstructive Surgery for Head and Neck Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The ALT flap may be harvested as a subcutaneous, fasciocutaneous, musculocutaneous, or adipofascial flap. At our institution, three surgeons commonly use this method of free tissue transfer to reconstruct such defects. In our experience, patients following harvest of ALT flap have impairments in lower extremity function that result in decreased independence with transfers, gait and ability to independently perform ADLs. Consequently, these patients receive Physical and Occupational Therapy following surgery and a number of patients go on to receive therapy in a rehabilitation facility and/or as an outpatient. A number of studies have examined donor site morbidity and lower extremity function following ALT flap harvest. These studies, however, are heterogeneous and primarily use patient reported and non-standardized scales as outcome measures. Additionally, there is a paucity of literature related to Physical Therapy and Occupational Therapy outcomes and intervention with this patient population, despite frequent referral of these patients for post-surgical therapy.
This investigation will utilize the Lower Extremity Functional Scale, the Functional Independence Measure, dynamometry, video analysis of a single leg squat and walking speed in an effort to better assess the affect of ALT harvesting on patients' functional capacity post operatively. These tests are valid and reliable measures commonly utilized in Physical Rehabilitation.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Rick Suggs
- Phone Number: 7737024036
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Over age 18;
- Head and neck cancer;
- To undergo anterolateral thigh free tissue transfer for head and neck reconstruction
Exclusion Criteria:
- Inability to ambulate independently prior to surgery;
- Inability to negotiate stairs prior to surgery;
- Inability to follow simple commands;
- Inability to negotiate stairs prior to surgery;
- Previous free flap harvest from either lower extremity
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower Extremity Functional Scale
Time Frame: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
|
The Lower Extremity Functional Scale (LEFS) is a validated self-report measure designed to assess the functional capabilities of patients with any lower extremity related musculoskeletal condition.
Subjects will be assessed for a change from pre- to post-operative
|
Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lower Extremity Function
Time Frame: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
|
Standing on one leg and walking, specifically duration of standing on one leg in minutes and distance walked up to 100 ft.
Subjects will be assessed from pre-to-postoperative to determine the decline in leg function.
|
Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
|
Functional Independence Measure
Time Frame: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
|
The Functional Independence Measure (FIM) will assess subject ability to perform activities of daily living such as bathing, lower body dressing, toileting, bed to chair transfer, toilet transfer, walking on level and stairs, social interaction, problem solving and memory.
We will assess the change from pre- to post-operative
|
Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
|
Lower Extremity Strength
Time Frame: Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
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Dynamometry will be performed in seated position to determine a change in muscle strength from pre- to post-operative
|
Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alexander Langerman, MD, University of Chicago
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-1375
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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