Visual ImpairmentNCT00650676
The Effect of Somatosensory Cue on Postural Stability in Blinded Persons
An observational study of Visual Impairment, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Blind Adults that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate in the movement and Rehabilitation Laboratory at Ben-Gurion University. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Visual Impairment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Jun 2010
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 blind persons and 30 control
Who may be able to join
- Blind persons
- Able to stand safely for 30 seconds
- Able to walk independently
- Hip OA prior THA
Who cannot join
- Stroke or other neurological diseases
- Orthopedic surgery at the past year
Trial locations and contacts
1 site in 1 country.
About this study
Blind Adults that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate in the movement and Rehabilitation Laboratory at Ben-Gurion University. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins \& De Luca, 1993). the subjects will be tested in 3 task conditions (eyes blindfolded, eyes blindfolded holding stick, eyes blindfolded holding a dog). Participants will be required to stand on the platform 10 times for 30 s For each trial, they will be instructed to sway as little as possible.
- Conditions
- Visual Impairment
- Medical subject headings
- Vision Disorders
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 |
|---|---|---|
| A | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
SDF parameters
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Itshak Melzer, PhD, Principal investigator, Ben-gurion University of the Negev, Beer-Sheva, IsraelRonit Yagev, MD, Study chair, Soroka University Medical Centar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650676
- Sponsor's protocol ID
- sor464308ctil
- Other IDs
- MY4643
- Status last verified
- Sep 2010
- First submitted
- 30 Mar 2008
- Last updated
- 21 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Somatosensory Cue on Postural Stability in Blinded Persons
- ClinicalTrials.gov ID
- NCT00650676
- Acronym / sponsor ID
- sor464308ctil
- Conditions
- Visual Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 2 Apr 2008 (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.
Blind Adults that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate in the movement and Rehabilitation Laboratory at Ben-Gurion University. An automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the COP data sets collected during quiet standing. These parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (Collins \& De Luca, 1993). the subjects will be tested in 3 task conditions (eyes blindfolded, eyes blindfolded holding stick, eyes blindfolded holding a dog). Participants will be required to stand on the platform 10 times for 30 s For each trial, they will be instructed to sway as little as possible.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | – |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 blind persons and 30 control
Key inclusion criteria (4 listed)
- Blind persons
- Able to stand safely for 30 seconds
- Able to walk independently
- Hip OA prior THA
Key exclusion criteria (2 listed)
- Stroke or other neurological diseases
- Orthopedic surgery at the past year
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
SDF parameters
Time frame: baseline
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 21 Sep 2010.
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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.
Itshak Melzer, PhD principal investigator
Ben-gurion University of the Negev, Beer-Sheva, Israel
Ronit Yagev, MD study chair
Soroka University Medical Centar
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 Visual Impairment, run by Soroka University 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 2 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 21 Sep 2010. 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.
What does the primary outcome measure?
SDF parameters (time frame: baseline). 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 21 Sep 2010.