Brain InjuryNCT01451216
The Evaluation of Balance Control by Quantification of Temporospatial Measures While Forward and Side Reaching
An observational study of Brain Injury, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Balance control is the sum action of the sense and reaction systems. In order to perform different activities in different postures one must have the ability to control and to adjust his balance in different conditions.A deficit in brain action following injury, disease or aging can undermine the ability to control… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Brain Injury
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2011to 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acquired Brain patients who are hospitalized in the Brain Injury department in Sheba Medical Center Israel for rehabilitation. Males and females, from them 20 aged 25-50, 20 aged 50-70.All the participents are able to stand without assistance for at list 10 sec. and can walk with or without walking aid. In addition they will not have any limitation of the upper or lower limbs range of motion.
Who may be able to join
- Acquired Brain Injury patients Can stand without assistance for at list 10 sec. Can walk 10m with or without walking aid Has no limitation in RPOM of the upper or lower limb need no guardian
Who cannot join
- Apraxia of all kind Aphasia Neglect
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba Medical Center
Ramat Gan
Ofer Keren, MD, 972-3-5305183, ofer.keren@sheba.health.gov.il
Michal Katz-Leurar, PhD
About this study
Official title: The Evaluation of Balance Control by Quantification of the Temporospatial Measures of Functional Reach Test
Balance control is the sum action of the sense and reaction systems. In order to perform different activities in different postures one must have the ability to control and to adjust his balance in different conditions.A deficit in brain action following injury, disease or aging can undermine the ability to control balance and increase the risk to fall.The limitation in gait and mobility can increase morbidity. There is a limited number of tools evaluating and recording balance control ability. Most of this tools are observational and can be used in the clinical field. The aim of this work is to estimate the feasibility of an objective tool that can evaluate balance by tracking objective quantitative measures during the standard physical therapy session without using an expensive equipment. By using this tool the therapist can monitor the patient and collect quantitive data while performing tasks while keeping balance. This tool will allow the therapist to detect changes in balance and evaluate the effect of different conditions on the patients balance. This tool is based on the well known functional reach test. The addition of this tool to the test is the use of a simple camera and a computer softwear that will collect the data and analyze it while performing the test. This tool will give the therapist information on the responsiveness and the spatiotemporal measures of the performance. The aim of this work is to check what is the contribution of spatiotemporal measures of the functional reach test among patients suffering from acquired brain injury to the understanding of the motor function and balance control of people suffering from brain injury. .
- Conditions
- Brain Injury
- Keywords
- Acquired brain injury, Balance control, Functional reach
- Medical subject headings
- Brain Injuries
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 |
|---|---|---|
| ABI 50-70 y | patients suffering from acquired brain injury aged 50-70 years old | |
| ABI 25-50y | Patients suffering from acquired brain injury aged 25-50 years oled |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ofer Keren, Sheba Medical Center
- Investigators
- Michal Katz-Leurar, PhD, Study chair, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451216
- Sponsor's protocol ID
- SHEBA-11-8745-OK-CTIL
- Status last verified
- Oct 2011
- First submitted
- 10 Oct 2011
- Last updated
- 18 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Balance Control by Quantification of the Temporospatial Measures of Functional Reach Test
- ClinicalTrials.gov ID
- NCT01451216
- Acronym / sponsor ID
- SHEBA-11-8745-OK-CTIL
- Conditions
- Brain Injury
- Keywords
- Acquired brain injury, Balance control, Functional reach
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Nov 2011
- First posted
- 13 Oct 2011 (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.
Balance control is the sum action of the sense and reaction systems. In order to perform different activities in different postures one must have the ability to control and to adjust his balance in different conditions.A deficit in brain action following injury, disease or aging can undermine the ability to control balance and increase the risk to fall.The limitation in gait and mobility can increase morbidity. There is a limited number of tools evaluating and recording balance control ability. Most of this tools are observational and can be used in the clinical field. The aim of this work is to estimate the feasibility of an objective tool that can evaluate balance by tracking objective quantitative measures during the standard physical therapy session without using an expensive equipment. By using this tool the therapist can monitor the patient and collect quantitive data while performing tasks while keeping balance. This tool will allow the therapist to detect changes in balance and evaluate the effect of different conditions on the patients balance. This tool is based on the well known functional reach test. The addition of this tool to the test is the use of a simple camera and a computer softwear that will collect the data and analyze it while performing the test. This tool will give the therapist information on the responsiveness and the spatiotemporal measures of the performance. The aim of this work is to check what is the contribution of spatiotemporal measures of the functional reach test among patients suffering from acquired brain injury to the understanding of the motor function and balance control of people suffering from brain injury. .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABI 50-70 y | – | –patients suffering from acquired brain injury aged 50-70 years old |
| ABI 25-50y | – | –Patients suffering from acquired brain injury aged 25-50 years oled |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acquired Brain patients who are hospitalized in the Brain Injury department in Sheba Medical Center Israel for rehabilitation. Males and females, from them 20 aged 25-50, 20 aged 50-70.All the participents are able to stand without assistance for at list 10 sec. and can walk with or without walking aid. In addition they will not have any limitation of the upper or lower limbs range of motion.
Key inclusion criteria (1 listed)
- Acquired Brain Injury patients Can stand without assistance for at list 10 sec. Can walk 10m with or without walking aid Has no limitation in RPOM of the upper or lower limb need no guardian
Key exclusion criteria (1 listed)
- Apraxia of all kind Aphasia Neglect
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 18 Oct 2011.
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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.
Michal Katz-Leurar, PhD study chair
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 Brain Injury, 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 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 18 Oct 2011. 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?
Contact Ofer Keren, MD (972-3-5305183, Ofer.Keren@sheba.health.gov.il), or a site near the patient. 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 18 Oct 2011.