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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02234505
Enrollment
12
Registered
2014-09-09
Start date
2014-09-30
Completion date
2015-11-30
Last updated
2015-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trans-tibial Limb Loss

Keywords

prosthetics, amputation, gait stability, step variability, load cell

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.

Interventions

PROCEDUREProsthetic alignment perturbation

Prosthetic ankle plantar-flexion will be modified in different degrees, devices (prosthetic components) will not be modified from baseline condition

Sponsors

American Orthotic and Prosthetic Association
CollaboratorOTHER
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Step-by-step variability2 hoursPeak 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026