Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees

Completed · Not applicable

Conditions studied: Transtibial Amputee

In brief

The purpose of the proposed study is to conduct research on individuals with lower limb amputation, evaluating if residual limb fluid volume data collected using a novel non-invasive device is beneficial towards prosthetic prescription, fit, and comfort as determined by amputee test subjects and practitioners (prosthetists). Participants' residual limb fluid volume will be monitored through bioimpedance analysis both before and after a practitioner-issued modification to the prosthesis as an observational cohort study and then as a blinded randomized control trial in which the data may or may not be shared with the practitioner before the modification is made to the prosthesis.

Key facts

Study ID

NCT03164356

Run by

University of Washington

People needed

68

Starts

2016-11-09

Expected to finish

2020-12-23

Last updated by the study team

2023-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Transtibial amputees, unilateral or bilateral
• Amputation at least 18 months prior
• Walking activity of at least 7 hours per week
• Medicare functional classification level of 2 or higher
• Residual limb length of at least 9 centimeters
• Detrimental impacts to socket fit caused by residual limb volume fluctuations
• Indication for augmented suspension, socket modification/change, sock application removal or activity modification

You may not qualify if…

• Incidence of skin breakdown
• Inability to ambulate continuously on a level walkway

Where it is running

• University of Washington Bioengineering — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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