Accommodating for Residual Limb Fluid Volume Change (AM-PM)

November 2, 2020 updated by: Joan Sanders, University of Washington
The purpose of this study is to quantify residual limb fluid volume changes between morning and afternoon hours, and to determine if fluid volume change is correlated with activity.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98075
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Transtibial amputee currently using prosthetic limbs

Description

Inclusion Criteria:

  • transtibial amputation
  • at least 18 months after amputation surgery
  • ability to walk on a treadmill and stand for 90 seconds

Exclusion Criteria:

  • skin breakdown on the residual limb

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Transtibial amputees

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Residual limb fluid volume
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of walking and moving
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 6, 2014

Study Completion (Actual)

June 6, 2014

Study Registration Dates

First Submitted

April 24, 2014

First Submitted That Met QC Criteria

April 25, 2014

First Posted (Estimate)

April 28, 2014

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00002557
  • R01HD060585 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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