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

NCT03164356 | Completed Results FDA Device

• 1 other identifier: STUDY00000969
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Transtibial Amputee

Keywords

Limb Fluid Volume Management; Prosthetic Socket Modification

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Significant Increases in Socket Comfort Score (SCS)

  Participants are asked to quantify the overall comfort of their prosthesis by giving it a score between 0 and 10 with 0 as the least comfortable possible and 10 being the most comfortable possible. SCS scores were acquired both pre and post making modifications to the participant's prosthesis. For analysis purposes, the number of participants that had a significant positive change are counted for this outcome. Participants that had little to no change (a score difference \<2) in SCS or had a negative change in SCS score were not counted.

  Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.

Secondary Outcomes (20)

• Number of Participants With Net-Positive Increase in Prosthesis Satisfaction, Measured by the Patient's Overall Satisfaction With Their Entire Prosthesis

  Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.

• Number of Participants With Net-Positive Change in Ambulation Score

  Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.

• Number of Participants With Net-Positive Change in Residual Limb Health Score

  Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.

• Number of Participants With Net-Positive Change in Prosthesis Utility Score

  Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.

• Number of Participants With Net-Positive Change in Prosthesis Well Being Score

  Baseline taken pre-modification, with a final score taken post-modification. The minimum time between scores was 3 weeks.

Study Arms (3)

Arm 1

NO INTERVENTION

In Arm 1, bioimpedance measurements are taken by research staff. The participants also wear an ActiGraph monitor for at least one week prior to their prosthetist preforming modifications to their socket.

Arm 2 - Experimental

EXPERIMENTAL

Conclusions drawn from data gathered in Arm 1 will be given to the participant's prosthetist, along with their bioimpedance data from Arm 2, to inform the practitioner's decision on when a modification to the socket is warranted. The results will be compared to those of Arm 3.

Device: Bioimpedance monitor

Arm 3 - Control

NO INTERVENTION

Bioimpedance data will be collected from participants in Arm 3 in parallel with those in Arm 2. However, no data will be provided to the participant's prosthetist.

Interventions

Bioimpedance monitor DEVICE

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.

Arm 2 - Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington Bioengineering

Seattle, Washington, 98105, United States

Location

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Related Links

• Sandia National Laboratories, Dynamic socket

Results Point of Contact

• Title: Daniel Ballesteros
• Organization: University of Washington

danieb25@uw.edu

206-221-5873

Study Officials

• Joan E Sanders, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Bioengineering

Study Record Dates

• First Submitted: March 16, 2017
• First Posted: May 23, 2017
• Study Start: November 9, 2016
• Primary Completion: September 14, 2020
• Study Completion: December 23, 2020
• Last Updated: May 3, 2023
• Results First Posted: April 22, 2022

Record last verified: 2023-04

Locations

US (1)