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

Not Applicable

Completed

• Conditions: Trans-tibial Limb Loss
• Interventions: Procedure: Prosthetic alignment perturbation

• Registration Number: NCT02234505
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-28
• Study Start: 2014-09
• Study First Submitted QC: 2014-09-04
• Study First Posted: 2014-09-09
• Primary Completion: 2015-08
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Trans-tibial prosthesis users	Prosthetic alignment perturbation	prosthetic alignment perturbation

Primary Outcome Measures

Name	Time	Method
Step-by-step variability	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.

Trial Locations

Locations (1)

Bakery Square MSPO labs; 🇺🇸 Pittsburgh, Pennsylvania, United States