Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces During Walking

December 3, 2015 updated by: Goeran Fiedler, University of Pittsburgh

Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces

In human gait there is a certain amount of variation between steps; some considered physiological and owed to variations in environment or posture, and some severe enough to be indicative of gait instabilities that may lead to stumbling and falling. In users of lower limb prosthetics, such gait instabilities are of especially great interest.

The study investigates the correlation between socket alignment quality and gait step-by-step variability in users of trans-tibial-prosthetics. It is hypothesized that a clearly defined range of step-by-step variability exists, and that therefore step-by-step variability is suitable as an outcome variable for the assessment of socket alignment.

A sample of ten persons with trans-tibial amputation will be recruited for this pilot study. Subjects will be asked to walk on different natural surfaces while the socket alignment is successively perturbed. Step-by-step variations in horizontal ground reaction forces and torsional moments will be measured and statistically compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

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
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15206
        • Bakery Square MSPO labs

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

Description

Inclusion Criteria:

  • activity classification of K2 to K4
  • experience in prosthesis use of at least one year
  • stated ability to walk pain free for at least 30 minutes

Exclusion Criteria:

  • age of less than 18 years
  • acute or ongoing residual limb pain
  • use of a prosthesis that is not suitable for installation of the load cell (e.g. is too short, or has non-removable cosmesis)

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trans-tibial prosthesis users
prosthetic alignment perturbation
Procedure: Prosthetic alignment perturbation
Prosthetic ankle plantar-flexion will be modified in different degrees, devices (prosthetic components) will not be modified from baseline condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Step-by-step variability
Time Frame: 2 hours
Peak horizontal ground reaction force (Fx and Fy) as well as peak axial torsion moment (Mz) will be extracted for 10 consecutive intermediary steps for each testing condition. Total range in Newtons over the 10 step sample, as well as maximal difference between consecutive steps in Newtons and percent will be reported for statistical analysis.
2 hours

Collaborators and Investigators

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

Sponsor

University of Pittsburgh

Collaborators

American Orthotic and Prosthetic Association

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

September 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

September 4, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PRO14040403

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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