BalanceNCT00817570
Evaluation of Balance Reactions of Transfemoral Amputees Using the Virtual Analysis System
An observational study of Balance, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to test and compare the balance reactions of Tranfemoral Amputees and able bodied subjects in response to perturbations given by a highly advanced Virtual Reality system. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Balance
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2009to not given
- 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
- Men only
- Healthy volunteers accepted
- Adult
Study population: Transfemoral Amputees and Able bodied.
Who may be able to join
- Transfemoral Amputees, walking without any assistive device, at least one year.
Who cannot join
- Amputees who suffer from a Neurological Injury/ disease that has implication on balance control.
- Amputees who suffer from Orthopedic Injury that has implication on balance control.
- Amputees who suffer from Cardiology disease that has implication on balance reactions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Balance Reactions of Transfemoral Amputees Using the Virtual
The purpose of this study is to test and compare the balance reactions of Tranfemoral Amputees and able bodied subjects in response to perturbations given by a highly advanced Virtual Reality system.
- Conditions
- Balance
- Keywords
- Trans Femoral Amputees Balance Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Transfemoral Amputees using the C- Leg knee. | |
| 2 | Transfemoral Amputees using a Multiaxial Knee. | |
| 3 | Able bodied. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817570
- Sponsor's protocol ID
- SHEBA-5610-08-IS-CTIL
- Status last verified
- Oct 2009
- First submitted
- 4 Jan 2009
- Last updated
- 22 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Balance Reactions of Transfemoral Amputees Using the Virtual
- ClinicalTrials.gov ID
- NCT00817570
- Acronym / sponsor ID
- SHEBA-5610-08-IS-CTIL
- Conditions
- Balance
- Keywords
- Trans Femoral Amputees Balance Reactions
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Apr 2009
- First posted
- 6 Jan 2009 (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 test and compare the balance reactions of Tranfemoral Amputees and able bodied subjects in response to perturbations given by a highly advanced Virtual Reality system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Transfemoral Amputees using the C- Leg knee. |
| 2 | – | –Transfemoral Amputees using a Multiaxial Knee. |
| 3 | – | –Able bodied. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Transfemoral Amputees and Able bodied.
Key inclusion criteria (1 listed)
- Transfemoral Amputees, walking without any assistive device, at least one year.
Key exclusion criteria (3 listed)
- Amputees who suffer from a Neurological Injury/ disease that has implication on balance control.
- Amputees who suffer from Orthopedic Injury that has implication on balance control.
- Amputees who suffer from Cardiology disease that has implication on balance reactions.
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Balance, 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 1 inclusion and 3 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: paused, as of the sponsor's last update on 22 Oct 2009. 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.
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 22 Oct 2009.