Effects of Ritalin on Postural Stability of Old Adults
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| First Received Date ICMJE | January 6, 2009 | ||||||||||||
| Last Updated Date | June 19, 2012 | ||||||||||||
| Start Date ICMJE | July 2011 | ||||||||||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Postural sway measures [ Time Frame: Time 1: pre test` and hour later time 2: post testinng proceedure ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT00817960 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Effects of Ritalin on Postural Stability of Old Adults | ||||||||||||
| Official Title ICMJE | Effects of Methylphenidate on Postural Stability of Old Adults Under Single and Dual Task Conditions. | ||||||||||||
| Brief 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 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. |
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| Detailed Description | Not Provided | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Postural Imbalance | ||||||||||||
| Intervention ICMJE | Drug: Methylphenidate
The effect of ritalin on postural stability of old adults (65 years old and over) will be measured using RCT study design |
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| Study Arm (s) | Experimental: Methylphenidate
Intervention: Drug: Methylphenidate |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 30 | ||||||||||||
| Completion Date | June 2012 | ||||||||||||
| Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 65 Years and older | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Israel | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00817960 | ||||||||||||
| Other Study ID Numbers ICMJE | SOR476508CTIL, MZ4765 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Soroka University Medical Center | ||||||||||||
| Study Sponsor ICMJE | Soroka University Medical Center | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Soroka University Medical Center | ||||||||||||
| Verification Date | December 2008 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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