NCT02601456

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

October 17, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

November 5, 2015

Last Update Submit

October 14, 2017

Conditions

Amputation, Traumatic

Keywords

Amputation, TraumaticBiomechanicsAsymmetryAmputee RunningProlonged Effort

Outcome Measures

Primary Outcomes (7)

  • The changes in step length asymmetry after prolonged effort in running on a treadmill.

    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.

    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.

    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.

    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.

    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

    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.

    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.

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Amputation, Traumatic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Itzhak Ziev-Ner, Dr.

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 10, 2015

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

October 17, 2017

Record last verified: 2017-01

Locations

IL(1)