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Effects of Ritalin on Postural Stability of Hyper Active Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00485797
First Posted: June 13, 2007
Last Update Posted: February 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Soroka University Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: June 12, 2007
First Posted: June 13, 2007
Last Update Posted: February 18, 2011
Last Verified: May 2007

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
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents