Effects of Ritalin on Postural Stability of Old Adults - Full Text View

Sponsored by:	Soroka University Medical Center
Information provided by:	Soroka University Medical Center
ClinicalTrials.gov Identifier:	NCT00817960

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: Ritalin

Drug Information available for: Methylphenidate hydrochloride Methylphenidate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effects of Methylphenidate on Postural Stability of Old Adults Under Single and Dual Task Conditions.

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 ]

Estimated Enrollment:	30
Study Start Date:	December 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Responsible Party:	Ben-Gurion University of the Negev ( Itshak Melzer PhD, PT )
Study ID Numbers:	SOR476508CTIL, MZ4765
Study First Received:	January 6, 2009
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00817960
Health Authority:	Israel: Clalit Health Service

Keywords provided by Soroka University Medical Center:

Dual tasking
Postural Control
Methylphenidate (Ritalin)
The focus of the study is To explore the effects of Ritalin on postural control in ADHD Children, during single and dual task conditions.
old adults (65 years old and older)

Study placed in the following topic categories:

Dopamine
Methylphenidate

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Physiological Effects of Drugs
Central Nervous System Stimulants
Dopamine Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009