Trials / Completed
CompletedNCT03164356
Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees
Portable Bioimpedance Monitoring: Testing a New Diagnostic Interface
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- University of Washington · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Bioimpedance monitor | Participant in aim 1 will be monitored using the bioimpedance monitor. Data obtained from the arm 1 cohort will be used to inform socket modifications made for arm 2 cohort. |
Timeline
- Start date
- 2016-11-09
- Primary completion
- 2020-09-14
- Completion
- 2020-12-23
- First posted
- 2017-05-23
- Last updated
- 2023-05-03
- Results posted
- 2022-04-22
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03164356. Inclusion in this directory is not an endorsement.