Changes in Trans Tibial Amputee Running Asymmetry During Prolonged Effort

Amputation, Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02601456
• Other study ID #: SHEBA-14-1834-ISN-CTIL
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 5, 2015
• Last updated: October 14, 2017
• Start date: May 2016
• Est. completion date: May 2018

Study information

• Verified date: January 2017
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amputation, Traumatic

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.