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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2023
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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)


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
surveys, evaluative tests for leg function
See outcome measures

Locations

Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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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