Effects of Ritalin on Postural Stability of Hyper Active Children

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Effects of Methylphenidate on Postural Stability of Children Suffer From Attention Deficit Hyperactivity Disorder (ADHD) Under Single and Dual Task Conditions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485797
• Other study ID #: SOR454707CTIL
• Secondary ID: MZ4547
• Status: Completed
• Phase: N/A
• First received: June 12, 2007
• Last updated: February 17, 2011
• Start date: October 2007
• Est. completion date: June 2008

Study information

• Verified date: May 2007
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Intervention

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

Locations

Country	Name	City	State
Israel	SorokaUMC	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural sway measures		Time 1: pre test` and hour later time 2: post testinng proceedure	No