Osteoarthrosis, Balance Control, Voluntary Movement ControlNCT00651430
Physical Functioning Following Total Hip Arthroplasty
An observational study of Osteoarthrosis, Balance Control, Voluntary Movement Control, run by Soroka University Medical Center at 2 sites in Israel.
Trial summary
Adults suffer from Osteoarthrosis of hip joint that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate before 3 month and 6 month after Total Knee Arthroplasty (THA) in the movement and Rehabilitation Laboratory at BGU. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthrosis, Balance Control, Voluntary Movement Control
- How many people
- 30 participants
- Where
- 2 sitesIsrael
- Study dates
- Mar 2008to May 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 adults suffer from Hip OA prior THA
Who may be able to join
- Able to stand safely for 30 seconds
- Able to walk independently
- Hip OA prior THA
Who cannot join
- Stroke or other neurological diseases
- Minimal score 24 or higher
- Blindness
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Step Execution, Stability, Quality of Life, Fear of Falling and Their Association Following Total Hip Arthroplasty
Adults suffer from Osteoarthrosis of hip joint that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate before 3 month and 6 month after Total Knee Arthroplasty (THA) in the movement and Rehabilitation Laboratory at BGU. 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). Each of the Times (before 3 month and 6 month after the THA) in two task conditions (eyes closed and eyes close conditions). 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. In addition step execution test and Late life function and disability questionnaires will be also examined.
- Keywords
- Balance, Voluntary stepping, function, disability, fear of falls, Total Hip Arthroplasty
- Medical subject headings
- Osteoarthritis
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: before, 3 month and 6 month after the THA
Secondary outcomes (1)
Late Life Function and disability, Fall efficacy scale, step execution test
Measured: before 3 month and 6 month after
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 startMar 2008
- Primary completionMay 2008
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthrosis, Balance Control, Voluntary Movement ControlStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Vadim Benkovich, MD, Study director, Soroka University Medical CenterItshak Melzer, PhD, PT, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651430
- Sponsor's protocol ID
- sor462807ctil
- Other IDs
- MB4628
- Status last verified
- Dec 2007
- First submitted
- 14 Jan 2008
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step Execution, Stability, Quality of Life, Fear of Falling and Their Association Following Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00651430
- Acronym / sponsor ID
- sor462807ctil
- Keywords
- Balance, Voluntary stepping, function, disability, fear of falls, Total Hip Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 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.
Adults suffer from Osteoarthrosis of hip joint that willing to participate in the study will be tested with well-established measuring techniques of Balance control using force plate before 3 month and 6 month after Total Knee Arthroplasty (THA) in the movement and Rehabilitation Laboratory at BGU. 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). Each of the Times (before 3 month and 6 month after the THA) in two task conditions (eyes closed and eyes close conditions). 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. In addition step execution test and Late life function and disability questionnaires will be also examined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | – |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 adults suffer from Hip OA prior THA
Key inclusion criteria (3 listed)
- Able to stand safely for 30 seconds
- Able to walk independently
- Hip OA prior THA
Key exclusion criteria (3 listed)
- Stroke or other neurological diseases
- Minimal score 24 or higher
- Blindness
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: before, 3 month and 6 month after the THA
1 secondary outcome
Late Life Function and disability, Fall efficacy scale, step execution test
Time frame: before 3 month and 6 month after
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 11 Jun 2010.
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.
Vadim Benkovich, MD study director
Soroka University Medical Center
Itshak Melzer, PhD, PT principal investigator
Ben-Gurion University of the Negev
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthrosis, Balance Control, Voluntary Movement Control, run by Soroka University Medical Center at 2 sites 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 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: finished, as of the sponsor's last update on 11 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: before, 3 month and 6 month after the THA). 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 11 Jun 2010.