Leg Function and ADL After ALT Reconstruction for Head and Neck Cancer

NCT02332161 | Completed

• 1 other identifier: 13-1375
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Free Tissue Flaps; Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Lower Extremity Function

  Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up

• Functional Independence Measure

  Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up

• Lower Extremity Strength

  Pre- and Postoperative - subjects will be followed until discharge, and assessed again at 1 month follow-up

Interventions

surveys, evaluative tests for leg function OTHER

See outcome measures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient over age 18 undergoing anterolateral thigh free tissue transfer for head and neck cancer reconstruction at the University of Chicago

You may qualify if:

• Over age 18;
• Head and neck cancer;
• To undergo anterolateral thigh free tissue transfer for head and neck reconstruction

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related 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.

  PMID: 10201543 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alexander Langerman, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2014
• First Posted: January 6, 2015
• Study Start: January 1, 2014
• Primary Completion: June 26, 2017
• Study Completion: June 26, 2017
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

US (1)