Clinical Trials Directory

Trials / Completed

CompletedNCT02332161

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

Status
Completed
Phase
Study type
Observational
Enrollment
8 (actual)
Sponsor
University of Chicago · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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)

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.

Conditions

Interventions

TypeNameDescription
OTHERsurveys, evaluative tests for leg functionSee outcome measures

Timeline

Start date
2014-01-01
Primary completion
2017-06-26
Completion
2017-06-26
First posted
2015-01-06
Last updated
2023-04-18

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02332161. Inclusion in this directory is not an endorsement.