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Effects of Ritalin on Postural Stability of Old Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00817960
First received: January 6, 2009
Last updated: June 19, 2012
Last verified: December 2008
History of Changes
  Purpose

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.


Condition Intervention
Postural Imbalance
 Drug: Methylphenidate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Methylphenidate on Postural Stability of Old Adults Under Single and Dual Task Conditions.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Postural sway measures [ Time Frame: Time 1: pre test` and hour later time 2: post testinng proceedure ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: July 2011
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methylphenidate Drug: Methylphenidate
The effect of ritalin on postural stability of old adults (65 years old and over) will be measured using RCT study design

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817960

Locations
Israel
SorokaUMC
Beer-Sheva, Israel, 84105
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Itshak Melzer, PhD Ben-gurion University of the Negev, Beer-Sheva, Israel
Study Chair: Zmir Shorer, m Soroka University Medical Centar
Study Director: Yan Press, MD Soroka Medical Center
  More Information

No publications provided

Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00817960     History of Changes
Other Study ID Numbers: SOR476508CTIL, MZ4765
Study First Received: January 6, 2009
Last Updated: June 19, 2012
Health Authority: Israel: Clalit Health Service

Keywords provided by Soroka University Medical Center:
Dual tasking
Postural Control
Methylphenidate (Ritalin)
old adults

Additional relevant MeSH terms:
Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013