Amputation, TraumaticNCT02601456
Changes in Trans Tibial Amputee Running Asymmetry During Prolonged Effort
An observational study of Amputation, Traumatic, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Amputation, Traumatic
- How many people
- 10 participants
- Where
- 1 siteIsrael
- Study dates
- May 2016to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: community sample
Who may be able to join
- Unilateral traumatic trans tibial amputee.
- Experience in running with running specific prosthesis.
- Ability to run for at least 20 minutes.
Who cannot join
- Injury or other orthopedic or neurologic issue that compromises the gait.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Amputation, Traumatic
- Keywords
- Amputation, Traumatic, Biomechanics, Asymmetry, Amputee Running, Prolonged Effort
- Medical subject headings
- Amputation, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Several measurements during 30 minutes run.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2015 (estimated)
- Study startMay 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation, TraumaticStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Itzhak Ziev-Ner, Dr., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02601456
- Sponsor's protocol ID
- SHEBA-14-1834-ISN-CTIL
- Status last verified
- Jan 2017
- First submitted
- 5 Nov 2015
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prolonged Effort on the Bilateral Asymmetry in Trans Tibial Amputee Running With Running Specific Prosthesis
- ClinicalTrials.gov ID
- NCT02601456
- Acronym / sponsor ID
- SHEBA-14-1834-ISN-CTIL
- Conditions
- Amputation, Traumatic
- Keywords
- Amputation, Traumatic, Biomechanics, Asymmetry, Amputee Running, Prolonged Effort
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- May 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 10 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- community sample
Key inclusion criteria (3 listed)
- Unilateral traumatic trans tibial amputee.
- Experience in running with running specific prosthesis.
- Ability to run for at least 20 minutes.
Key exclusion criteria (1 listed)
- Injury or other orthopedic or neurologic issue that compromises the gait.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Itzhak Ziev-Ner, Dr. principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, Traumatic, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes in step length asymmetry after prolonged effort in running on a treadmill. (time frame: Several measurements during 20-30 minutes run.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017.