N/A
N=68
Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees
Transtibial Amputee
Bottom Line
View on ClinicalTrials.gov: NCT03164356 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Number of Participants With Significant Increases in Socket Comfort Score (SCS) — 5; 6; 4 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bioimpedance monitor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Significant Increases in Socket Comfort Score (SCS) |
5; 6; 4 | — |
| SECONDARY Number of Participants With Net-Positive Increase in Prosthesis Satisfaction, Measured by the Patient's Overall Satisfaction With Their Entire Prosthesis |
8; 6; 6 | — |
| SECONDARY Number of Participants With Net-Positive Change in Ambulation Score |
11; 8; 8 | — |
| SECONDARY Number of Participants With Net-Positive Change in Residual Limb Health Score |
10; 3; 6 | — |
| SECONDARY Number of Participants With Net-Positive Change in Prosthesis Utility Score |
11; 9; 9 | — |
| SECONDARY Number of Participants With Net-Positive Change in Prosthesis Well Being Score |
8; 7; 6 | — |
| SECONDARY Prosthetist Communication Assessment Score, Measured by the Communication Efficacy Between the Prosthetist and Their Patient |
9; 8.8 | — |
| SECONDARY Types of Socket Modifications Implemented Per Group |
9; 11; 1; 3; 0; 1 | — |
| SECONDARY Effect of Socket Modification, Measured by the Impact of the Physical Modification Made to the Prosthesis to Socket Fit |
8.3; 8.6 | — |
| SECONDARY Strategies Recommended to Minimize Limb Fluid Volume Loss |
2; 3; 3; 1; 0; 0 | — |
| SECONDARY Effect of Volume Management Strategy, Measured by the Impact of the Changes in Volume Management to Socket Fit |
6.3; 6.7 | — |
| SECONDARY Modification/Strategy Satisfaction, Measured by Overall Satisfaction of All Methods Employed |
8.4; 7.9 | — |
| SECONDARY Prosthetist Impression of Bioimpedance Results, Measured by General Feedback From Clinicians on the Bioimpedance Data They Are Given |
4; 3; 2; 4 | — |
| SECONDARY Prosthetist Use of Bioimpedance Results, Measured by General Feedback on How the Clinicians Use the Bioimpedance Data They Are Given |
2; 3; 3; 2; 1 | — |
| SECONDARY Bioimpedance Usefulness for Socket Design, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications |
6.9 | — |
| SECONDARY Bioimpedance for Volume Management, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications |
8.3 | — |
| SECONDARY Continuing Use of Bioimpedance Results, Measured by How Likely Clinicians Will be to Use Bioimpedance Data in the Future |
8.5 | — |
| SECONDARY Impact of Bioimpedance, Measured by How Bioimpedance Data Changed the Way Prosthetists Approach Problem Issues of Socket Fit |
5.9 | — |
| SECONDARY Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians |
4; 4; 3; 5; 6; 2 | — |
| SECONDARY Bioimpedance and Communication Measured by General Feedback on Whether Prosthetist-patient Communication is Improved Through Use of Bioimpedance Data |
8.1 | — |
| SECONDARY Outcome Enhancement, Measured by the Degree to Which Outcomes Are Improved Using Bioimpedance Data |
6.6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03164356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.