- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00817960
Effects of Ritalin on Postural Stability of Old Adults
June 19, 2012 updated by: Soroka University Medical Center
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Beer-Sheva, Israel, 84105
- SorokaUMC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 65 years old and older
- independent elderly adults
- do not suffer from balance prblems
- minimental score 24 and above
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Methylphenidate
|
The effect of ritalin on postural stability of old adults (65 years old and over) will be measured using RCT study design
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Postural sway measures
Time Frame: Time 1: pre test' and hour later time 2: post testinng proceedure
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Time 1: pre test' and hour later time 2: post testinng proceedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Zmir Shorer, m, Soroka University Medical Centar
- Study Director: Yan Press, MD, Soroka University Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (ACTUAL)
January 1, 2012
Study Completion (ACTUAL)
June 1, 2012
Study Registration Dates
First Submitted
January 6, 2009
First Submitted That Met QC Criteria
January 6, 2009
First Posted (ESTIMATE)
January 7, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
June 20, 2012
Last Update Submitted That Met QC Criteria
June 19, 2012
Last Verified
December 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOR476508CTIL
- MZ4765
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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