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

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University of Pittsburgh

Status

Completed

Conditions

Trans-tibial Limb Loss

Treatments

Procedure: Prosthetic alignment perturbation

Study type

Interventional

Funder types

Other

Identifiers

NCT02234505
PRO14040403

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Trans-tibial prosthesis users
Experimental group
Description:
prosthetic alignment perturbation
Treatment:
Procedure: Prosthetic alignment perturbation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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