Effects of Ritalin on Postural Stability of Hyper Active Children

NCT ID: NCT00485797

Last Updated: 2011-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Attention Deficit Disorder With Hyperactivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Interventions

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Ritalin

The effect of ritalin on postural stability of ADHD childrens will be measured using RCT study design

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ben-Gurion University of the Negev

Principal Investigators

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Itshak Melzer, Dr

Role: PRINCIPAL_INVESTIGATOR

Ben-gurion University of the Negev, Beer-Sheva, Israel

Zmir Shorer, Dr

Role: STUDY_CHAIR

Soroka Medical Centar

Press Yossi, Prof

Role: STUDY_DIRECTOR

Soroka University Medical Center

Locations

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SorokaUMC

Beersheba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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MZ4547

Identifier Type: -

Identifier Source: secondary_id

SOR454707CTIL

Identifier Type: -

Identifier Source: org_study_id

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