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Effects of Ritalin on Postural Stability of Hyper Active Children

This study has been completed.
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00485797
First received: June 12, 2007
Last updated: February 17, 2011
Last verified: May 2007
History of Changes
  Purpose

Experimental design overview The proposed project is a prospective experimental study design. Children (age <15) suffer from attention deficit hyperactivity disorder (ADHD) that their Parents willing to participate in the study will be tested with well-established measuring techniques of Balance control before and 1 hour 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
Attention Deficit Disorder With Hyperactivity
 Drug: Ritalin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Methylphenidate on Postural Stability of Children Suffer From Attention Deficit Hyperactivity Disorder (ADHD) 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: October 2007
Study Completion Date: June 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ritalin
    The effect of ritalin on postural stability of ADHD childrens will be measured using RCT study design
  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 6-12 years old
  • Diagnosed as ADHD childrens by a neurologist
  • Taking methylphenidate (Ritalin)

Exclusion Criteria:

  • Children who suffer from CP, or other neurological disease
  • Children who suffer from psychiatric state
  • Children who suffer from orthopedic condition (1/2 a year after a fracture in the lower limb)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00485797

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

No publications provided

Responsible Party: Itshak Melzer PhD, PT, Ben-Gurion University of the Negev
ClinicalTrials.gov Identifier: NCT00485797     History of Changes
Other Study ID Numbers: SOR454707CTIL, MZ4547
Study First Received: June 12, 2007
Last Updated: February 17, 2011
Health Authority: Israel: Clalit Health Service

Keywords provided by Soroka University Medical Center:
attention deficit hyperactivity disorder (ADHD)
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.

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 21, 2013