Head and Neck Neoplasms Clinical Trial
Official title:
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
NCT number | NCT02332161 |
Other study ID # | 13-1375 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2014 |
Est. completion date | June 26, 2017 |
Verified date | April 2023 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Anterolateral thigh (ALT) free flap tissue transfer is a commonly used method of head and neck reconstruction after head and neck cancer removal. The procedure involves removing some muscle, skin, and tissue from the thigh, and this may affect leg function. The purpose of this study is to determine the impact of ALT on ambulation and activities of daily living (ADLs)
Status | Completed |
Enrollment | 8 |
Est. completion date | June 26, 2017 |
Est. primary completion date | June 26, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Over age 18; 2. Head and neck cancer; 3. To undergo anterolateral thigh free tissue transfer for head and neck reconstruction Exclusion Criteria: 1. Inability to ambulate independently prior to surgery; 2. Inability to negotiate stairs prior to surgery; 3. Inability to follow simple commands; 4. Inability to negotiate stairs prior to surgery; 5. Previous free flap harvest from either lower extremity |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lower Extremity Functional Scale | 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 | Lower Extremity Function | 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 | |
Secondary | Functional Independence Measure | 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 | |
Secondary | Lower Extremity Strength | 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 |
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