Amputations, TraumaticNCT00353626
Gait Evaluation of Experienced Below Knee Amputees
An observational study of Amputations, Traumatic, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Post traumatic amputees with an experience of over 3 months of prosthesis use at home, without any known difficulty using the prosthesis and without stump pathology, using no assistive devices, will be examined in a 3 D computerized gait laboratory. Kinematic and kinetic parameters of gait will be obtained. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Amputations, Traumatic
- How many people
- 9 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2006to Sep 2007
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Trans tibial amputees without pain or complaints about stump or prosthesis,using their prosthesis more than 3 months.
Who may be able to join
- Post traumatic trans tibial amputees
- No stump pathology
- No assistive devices
- No technical difficulty
Who cannot join
- Vascular or DM background
- Stump pathology
- Gait difficulties
- Assistive device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gait Evaluation of Experienced Post Traumatic Below Knee Amputees
Post traumatic amputees with an experience of over 3 months of prosthesis use at home, without any known difficulty using the prosthesis and without stump pathology, using no assistive devices, will be examined in a 3 D computerized gait laboratory. Kinematic and kinetic parameters of gait will be obtained.
- Conditions
- Amputations, Traumatic
- Keywords
- Amputation, trans tibial, prosthesis, motion analysis
- Medical subject headings
- Amputation, Traumatic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionJul 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputations, 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
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Uri Givon, MD, Principal investigator, Motion analysis Laboratory, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353626
- Sponsor's protocol ID
- SHEBA-06-4211-UG-CTIL
- Status last verified
- Mar 2008
- First submitted
- 16 Jul 2006
- Last updated
- 24 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Evaluation of Experienced Post Traumatic Below Knee Amputees
- ClinicalTrials.gov ID
- NCT00353626
- Acronym / sponsor ID
- SHEBA-06-4211-UG-CTIL
- Conditions
- Amputations, Traumatic
- Keywords
- Amputation, trans tibial, prosthesis, motion analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 18 Jul 2006 (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.
Post traumatic amputees with an experience of over 3 months of prosthesis use at home, without any known difficulty using the prosthesis and without stump pathology, using no assistive devices, will be examined in a 3 D computerized gait laboratory. Kinematic and kinetic parameters of gait will be obtained.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Trans tibial amputees without pain or complaints about stump or prosthesis,using their prosthesis more than 3 months.
Key inclusion criteria (4 listed)
- Post traumatic trans tibial amputees
- No stump pathology
- No assistive devices
- No technical difficulty
Key exclusion criteria (4 listed)
- Vascular or DM background
- Stump pathology
- Gait difficulties
- Assistive device
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2008.
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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.
Uri Givon, MD principal investigator
Motion analysis Laboratory, 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 Amputations, 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 24 Mar 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 24 Mar 2008.