Postural ImbalanceNCT00817960
Effects of Ritalin on Postural Stability of Old Adults
A study testing Methylphenidate in people with Postural Imbalance, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
Experimental design overview The proposed project is a prospective experimental study design. independent old adults(age 65 years old and older) who do not suffer from balance problems willing to participate in the study will be tested with well-established measuring techniques of Balance control before and 2 hours… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postural Imbalance
- What is being tested?
- Methylphenidate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Jun 2012
- Phase
- Interventional
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 65 years old and older
- independent elderly adults
- do not suffer from balance prblems
- minimental score 24 and above
Who cannot join
- old adults who suffer from neurological disease or stroke
- old adults who suffer from psychiatric state
- old adults who suffer from orthopedic condition (1/2 a year after a fracture in the lower limb)
- old adults who suffer from heart conditions
- old adults who suffer from blindness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Methylphenidate on Postural Stability of Old Adults Under Single and Dual Task Conditions.
Experimental design overview The proposed project is a prospective experimental study design. independent old adults(age 65 years old and older) who do not suffer from balance problems willing to participate in the study will be tested with well-established measuring techniques of Balance control before and 2 hours after taking of Methylphenidate (Ritalin) 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). For each of the conditions (before and 1 hour after the use of Ritalin) in three task conditions single task; dual task (concentrating and identifying specific music); and just Listening to a relaxing music. 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
- Postural Imbalance
- Being tested
- Methylphenidate
- Keywords
- Dual tasking, Postural Control, Methylphenidate (Ritalin), old adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
The effect of ritalin on postural stability of old adults (65 years old and over) will be measured using RCT study design
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate | Experimental | Not described Receives: Drug: Methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural sway measures
Measured: Time 1: pre test' and hour later time 2: post testinng proceedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startJul 2011
- Primary completionJan 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural ImbalanceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Itshak Melzer, PhD, Principal investigator, Ben-gurion University of the Negev, Beer-Sheva, IsraelZmir Shorer, m, Study chair, Soroka University Medical CentarYan Press, MD, Study director, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817960
- Sponsor's protocol ID
- SOR476508CTIL
- Other IDs
- MZ4765
- Status last verified
- Dec 2008
- First submitted
- 6 Jan 2009
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Methylphenidate on Postural Stability of Old Adults Under Single and Dual Task Conditions.
- ClinicalTrials.gov ID
- NCT00817960
- Acronym / sponsor ID
- SOR476508CTIL
- Conditions
- Postural Imbalance
- Keywords
- Dual tasking, Postural Control, Methylphenidate (Ritalin), old adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 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.
Experimental design overview The proposed project is a prospective experimental study design. independent old adults(age 65 years old and older) who do not suffer from balance problems willing to participate in the study will be tested with well-established measuring techniques of Balance control before and 2 hours after taking of Methylphenidate (Ritalin) 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). For each of the conditions (before and 1 hour after the use of Ritalin) in three task conditions single task; dual task (concentrating and identifying specific music); and just Listening to a relaxing music. 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Experimental | Drug: Methylphenidate |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 years old and older
- independent elderly adults
- do not suffer from balance prblems
- minimental score 24 and above
Key exclusion criteria (5 listed)
- old adults who suffer from neurological disease or stroke
- old adults who suffer from psychiatric state
- old adults who suffer from orthopedic condition (1/2 a year after a fracture in the lower limb)
- old adults who suffer from heart conditions
- old adults who suffer from blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateThe effect of ritalin on postural stability of old adults (65 years old and over) will be measured using RCT study design | Drug | Methylphenidate |
Primary outcome
Postural sway measures
Time frame: Time 1: pre test' and hour later time 2: post testinng proceedure
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 20 Jun 2012.
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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
Zmir Shorer, m study chair
Soroka University Medical Centar
Yan Press, MD study director
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylphenidate in people with Postural Imbalance, 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 5 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 20 Jun 2012. 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?
Postural sway measures (time frame: Time 1: pre test' and hour later time 2: post testinng proceedure). 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 20 Jun 2012; AzTrials last refreshed its copy on 7 Nov 2026.