Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/16/2018 |
| Start Date: | November 9, 2016 |
| End Date: | January 1, 2020 |
| Contact: | Joan E Sanders, PhD |
| Email: | jsanders@u.washington.edu |
| Phone: | (206)221-5872 |
Portable Bioimpedance Monitoring: Testing a New Diagnostic Interface
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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- Incidence of skin breakdown
- Inability to ambulate continuously on a level walkway
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