Physiologic Range of Step-by-step Variations in Lower Limb Prosthesis Forces During Walking
NCT ID: NCT02234505
Last Updated: 2015-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2014-09-30
2015-11-30
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Trans-tibial prosthesis users
prosthetic alignment perturbation
Prosthetic alignment perturbation
Prosthetic ankle plantar-flexion will be modified in different degrees, devices (prosthetic components) will not be modified from baseline condition
Interventions
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Prosthetic alignment perturbation
Prosthetic ankle plantar-flexion will be modified in different degrees, devices (prosthetic components) will not be modified from baseline condition
Eligibility Criteria
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Inclusion Criteria
* experience in prosthesis use of at least one year
* stated ability to walk pain free for at least 30 minutes
Exclusion Criteria
* 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)
18 Years
ALL
Yes
Sponsors
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American Orthotic and Prosthetic Association
OTHER
University of Pittsburgh
OTHER
Responsible Party
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Goeran Fiedler
Assistant Professor
Locations
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Bakery Square MSPO labs
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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PRO14040403
Identifier Type: -
Identifier Source: org_study_id