Effects of Ritalin on Postural Stability of Hyper Active Children

NCT00485797 | Completed DMC

• 2 other identifiers: SOR454707CTILMZ4547
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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.

Outcome Measures

Primary Outcomes (1)

• Postural sway measures

  Time 1: pre test' and hour later time 2: post testinng proceedure

Interventions

Ritalin DRUG

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

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 6-12 years old
• Diagnosed as ADHD childrens by a neurologist
• Taking methylphenidate (Ritalin)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Soroka University Medical Center: lead

Study Sites (1)

SorokaUMC

Beersheba, Israel

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Itshak Melzer, Dr

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

  PRINCIPAL INVESTIGATOR

• Zmir Shorer, Dr

  Soroka Medical Centar

  STUDY CHAIR

• Press Yossi, Prof

  Soroka University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 13, 2007
• Study Start: October 1, 2007
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2008
• Last Updated: February 18, 2011

Record last verified: 2007-05

Locations

IL (1)