Changes in Trans Tibial Amputee Running Asymmetry During Prolonged Effort

October 14, 2017 updated by: Sheba Medical Center

The Effect of Prolonged Effort on the Bilateral Asymmetry in Trans Tibial Amputee Running With Running Specific Prosthesis

The purpose of this study is to determine the effect of prolonged effort in long distance running on the biomechanical bilateral asymmetry in the lower limbs of trans tibial amputee running with running specific prosthesis.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community sample

Description

Inclusion Criteria:

  • Unilateral traumatic trans tibial amputee.
  • Experience in running with running specific prosthesis.
  • Ability to run for at least 20 minutes.

Exclusion Criteria:

  • Injury or other orthopedic or neurologic issue that compromises the gait.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes in step length asymmetry after prolonged effort in running on a treadmill.
Time Frame: Several measurements during 20-30 minutes run.
Step length will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30. If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.
Several measurements during 20-30 minutes run.
The changes in contact time asymmetry after prolonged effort in running on a treadmill.
Time Frame: Several measurements during 30 minutes run.
Contact time will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30. If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.
Several measurements during 30 minutes run.
The changes in flight time asymmetry after prolonged effort in running on a treadmill.
Time Frame: Several measurements during 30 minutes run.
Flight time will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30. If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.
Several measurements during 30 minutes run.
The changes in hip angles asymmetry after prolonged effort in running on a treadmill.
Time Frame: Several measurements during 30 minutes run.
Hip angles will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30. If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.
Several measurements during 30 minutes run.
The changes in knee angles asymmetry after prolonged effort in running on a treadmill.
Time Frame: Several measurements during 30 minutes run.
Knee angles will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30. If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.
Several measurements during 30 minutes run.
The changes in vertical ground reaction force asymmetry after prolonged effort in running. on a treadmill
Time Frame: Several measurements during 30 minutes run.
Vertical ground reaction force will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30. If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.
Several measurements during 30 minutes run.
The changes in ground reaction impulse asymmetry after prolonged effort in running on a treadmill.
Time Frame: Several measurements during 30 minutes run.
Vertical ground reaction impulse will be recorded by the v-gait analysis system during the running test for 20 seconds at certain points of the run: minute 0, 5, 10, 15, 20, 25, 30. If the subject will ask to stop the run, 20 seconds will be recorded prior to the termination of the run.
Several measurements during 30 minutes run.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Itzhak Ziev-Ner, Dr., Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

November 5, 2015

First Submitted That Met QC Criteria

November 9, 2015

First Posted (Estimate)

November 10, 2015

Study Record Updates

Last Update Posted (Actual)

October 17, 2017

Last Update Submitted That Met QC Criteria

October 14, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-14-1834-ISN-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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