Effects of Ritalin on Postural Stability of Hyper Active Children
Primary Purpose
Attention Deficit Disorder With Hyperactivity
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ritalin
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring 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.
Eligibility 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)
Sites / Locations
- SorokaUMC
Outcomes
Primary Outcome Measures
Postural sway measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00485797
First Posted
June 12, 2007
Last Updated
February 17, 2011
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00485797
Brief Title
Effects of Ritalin on Postural Stability of Hyper Active Children
Official Title
Effects of Methylphenidate on Postural Stability of Children Suffer From Attention Deficit Hyperactivity Disorder (ADHD) Under Single and Dual Task Conditions.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity
Keywords
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.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ritalin
Intervention Description
The effect of ritalin on postural stability of ADHD childrens will be measured using RCT study design
Primary Outcome Measure Information:
Title
Postural sway measures
Time Frame
Time 1: pre test' and hour later time 2: post testinng proceedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Itshak Melzer, Dr
Organizational Affiliation
Ben-gurion University of the Negev, Beer-Sheva, Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zmir Shorer, Dr
Organizational Affiliation
Soroka Medical Centar
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Press Yossi, Prof
Organizational Affiliation
Soroka University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
SorokaUMC
City
Beer-Sheva
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Effects of Ritalin on Postural Stability of Hyper Active Children
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