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Sponsored by: |
Soroka University Medical Center |
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Information provided by: | Soroka University Medical Center |
ClinicalTrials.gov Identifier: | NCT00485797 |
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 |
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Attention Deficit Disorder With Hyperactivity |
Drug: Ritalin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effects of Methylphenidate on Postural Stability of Children Suffer From Attention Deficit Hyperactivity Disorder (ADHD) Under Single and Dual Task Conditions. |
Estimated Enrollment: | 30 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 6 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Itsahk Melzer, Dr | 972-8-6477727 | itzikm@bgu.ac.il |
Israel | |
SorokaUMC | Recruiting |
Beer-Sheva, Israel | |
Contact: Itshak Melzer, PhD 972-8-647727 itzikm@bgu.ac.il |
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 |
Responsible Party: | Ben-Gurion University of the Negev ( Itshak Melzer PhD, PT ) |
Study ID Numbers: | SOR454707CTIL, MZ4547 |
Study First Received: | June 12, 2007 |
Last Updated: | March 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00485797 |
Health Authority: | Israel: Clalit Health Service |
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. |
Signs and Symptoms Dopamine Attention Deficit Disorder with Hyperactivity Mental Disorders Mental Disorders Diagnosed in Childhood |
Methylphenidate Neurologic Manifestations Attention Deficit and Disruptive Behavior Disorders Hyperkinesis Dyskinesias |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Disease Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs |
Central Nervous System Stimulants Pharmacologic Actions Pathologic Processes Therapeutic Uses Dopamine Agents Central Nervous System Agents |