Biomechanical Assessment of Gait in Lower-Extremity-Amputees

NCT01332123 | Completed Results

• 1 other identifier: UWM-11.254
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study is investigating the influence of several simulated real life conditions on the symmetry of gait with trans-tibial prostheses Hypotheses: It is hypothesized that the observable differences in gait pattern between amputees can be detected by a combination of forces and moments that are measured internally in the prosthesis, and electromyography data. It is further hypothesized that changing conditions such as uneven walking surface, prosthetic misalignment or user fatigue are characterized by typical values in the measured data or combinations thereof.

Conditions

Prosthesis User

Outcome Measures

Primary Outcomes (1)

• Overall Asymmetry Index

  Gait data was continuously recorded and was post processed to determine symmetry between left and right legs. Symmetry was computed by dividing the difference between legs by the average of both legs. 0 marks perfect symmetry and greater values higher asymmetry. There is no maximum limit. The overall asymmetry index was calculated as the mean of the following: max knee flex, dorsi flexion, plantar flexion (1st and 2nd peak), knee moment, dorsi-flexion moment, plantar-flexion moment, times of max in % of the gait cycle, Stance phase % of gait cycle and step length. The kinematics asymmetry index was calculated as the mean of the following: maximal knee flex, dorsi flexion, plantar flexion (1st and 2nd peak), the times of max in % of the gait cycle, Stance phase % of gait cycle and step length. The kinetics asymmetry index was calculated as the mean of the following variables: knee moment, dorsi-flexion moment, plantar-flexion moment, the times of max in % of the gait cycle.

  1 hour

Secondary Outcomes (1)

• Heart Rate Change

  1 hour

Study Arms (1)

Alignment perturbations

EXPERIMENTAL

The following modifications will be applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)

Device: Alignment perturbations

Interventions

Alignment perturbations DEVICE

Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)

Alignment perturbations

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trans tibial amputation
• Able to walk 30 minutes comfortably
• Modular prosthesis

You may not qualify if:

• Prosthesis does not provide enough space between socket and foot module to fit the mobile measuring unit
• Physically or mentally unable to perform the required tasks

Sponsors & Collaborators

• University of Wisconsin, Milwaukee: lead

Study Sites (1)

USR, 115 E Reindl Way

Milwaukee, Wisconsin, 53211, United States

Location

Results Point of Contact

• Title: Goeran Fiedler
• Organization: university of pittsburgh

gfiedler@pitt.edu

4126246475

Study Officials

• Brooke A Slavens, PhD

  UWM CHS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student-PI

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 8, 2011
• Study Start: April 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: August 1, 2012
• Last Updated: June 9, 2016
• Results First Posted: June 9, 2016

Record last verified: 2016-06

Locations

US (1)