Clinical trial NCT03164356: Bioimpedance as a Diagnostic Tool for Assessing the Need for Socket Modification in Transtibial Amputees
Official title: Portable Bioimpedance Monitoring: Testing a New Diagnostic Interface
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transtibial Amputee
Keywords: Limb Fluid Volume Management
Prosthetic Socket Modification
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief 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

Primary outcomes:
measure: Number of Participants With Significant Increases in Socket Comfort Score (SCS)
timeFrame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
Secondary outcomes:
measure: Number of Participants With Net-Positive Increase in Prosthesis Satisfaction, Measured by the Patient's Overall Satisfaction With Their Entire Prosthesis
timeFrame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
measure: Number of Participants With Net-Positive Change in Ambulation Score
timeFrame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
measure: Number of Participants With Net-Positive Change in Residual Limb Health Score
timeFrame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
measure: Number of Participants With Net-Positive Change in Prosthesis Utility Score
timeFrame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
measure: Number of Participants With Net-Positive Change in Prosthesis Well Being Score
timeFrame: Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.
measure: Prosthetist Communication Assessment Score, Measured by the Communication Efficacy Between the Prosthetist and Their Patient
timeFrame: Baseline, prior to socket modification
measure: Types of Socket Modifications Implemented Per Group
timeFrame: Baseline, prior to socket modification
measure: Effect of Socket Modification, Measured by the Impact of the Physical Modification Made to the Prosthesis to Socket Fit
timeFrame: Post modification, minimum 4 weeks after patient started study
measure: Strategies Recommended to Minimize Limb Fluid Volume Loss
timeFrame: Post modification, minimum 4 weeks after patient started study
measure: Effect of Volume Management Strategy, Measured by the Impact of the Changes in Volume Management to Socket Fit
timeFrame: Post modification, minimum 4 weeks after patient started study
measure: Modification/Strategy Satisfaction, Measured by Overall Satisfaction of All Methods Employed
timeFrame: Post modification, minimum 4 weeks after patient started study
measure: Prosthetist Impression of Bioimpedance Results, Measured by General Feedback From Clinicians on the Bioimpedance Data They Are Given
timeFrame: Post modification, minimum 4 weeks after patient started study
measure: Prosthetist Use of Bioimpedance Results, Measured by General Feedback on How the Clinicians Use the Bioimpedance Data They Are Given
timeFrame: Post modification, minimum 4 weeks after patient started study
measure: Bioimpedance Usefulness for Socket Design, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications
timeFrame: Post modification, minimum 4 weeks after patient started study
measure: Bioimpedance for Volume Management, Measured by General Feedback on How Useful Bioimpedance is for Informing Decisions on Socket Modifications
timeFrame: Post modification, minimum 4 weeks after patient started study
measure: Continuing Use of Bioimpedance Results, Measured by How Likely Clinicians Will be to Use Bioimpedance Data in the Future
timeFrame: Post modification, minimum 4 weeks after patient started study
measure: Impact of Bioimpedance, Measured by How Bioimpedance Data Changed the Way Prosthetists Approach Problem Issues of Socket Fit
timeFrame: Post modification, minimum 4 weeks after patient started study
measure: Most Useful Bioimpedance Data, Measured by Which Element of the Bioimpedance Data is Most Useful to Clinicians
timeFrame: Post modification, minimum 4 weeks after patient started study
measure: Bioimpedance and Communication Measured by General Feedback on Whether Prosthetist-patient Communication is Improved Through Use of Bioimpedance Data
timeFrame: Post modification, minimum 4 weeks after patient started study
measure: Outcome Enhancement, Measured by the Degree to Which Outcomes Are Improved Using Bioimpedance Data
timeFrame: Post modification, minimum 4 weeks after patient started study
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Bioengineering
state: Washington
Study officials:
affiliation: University of Washington
name: Joan E Sanders, PhD
role: PRINCIPAL_INVESTIGATOR
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