Attention Deficit Disorder With HyperactivityNCT00485797
Effects of Ritalin on Postural Stability of Hyper Active Children
A study testing Ritalin in people with Attention Deficit Disorder With Hyperactivity, run by Soroka University Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Ritalin
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2007to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 6-12 years old
- Diagnosed as ADHD childrens by a neurologist
- Taking methylphenidate (Ritalin)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Methylphenidate on Postural Stability of Children Suffer From Attention Deficit Hyperactivity Disorder (ADHD) Under Single and Dual Task Conditions.
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.
- Being tested
- Ritalin
- 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.
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RitalinDrug
The effect of ritalin on postural stability of ADHD childrens will be measured using RCT study design
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural sway measures
Measured: Time 1: pre test' and hour later time 2: post testinng proceedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Itshak Melzer, Dr, Principal investigator, Ben-gurion University of the Negev, Beer-Sheva, IsraelZmir Shorer, Dr, Study chair, Soroka Medical CentarPress Yossi, Prof, Study director, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485797
- Sponsor's protocol ID
- SOR454707CTIL
- Other IDs
- MZ4547
- Status last verified
- May 2007
- First submitted
- 12 Jun 2007
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Methylphenidate on Postural Stability of Children Suffer From Attention Deficit Hyperactivity Disorder (ADHD) Under Single and Dual Task Conditions.
- ClinicalTrials.gov ID
- NCT00485797
- Acronym / sponsor ID
- SOR454707CTIL
- 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.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 13 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 6-12 years old
- Diagnosed as ADHD childrens by a neurologist
- Taking methylphenidate (Ritalin)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RitalinThe effect of ritalin on postural stability of ADHD childrens will be measured using RCT study design | Drug | – |
Primary outcome
Postural sway measures
Time frame: Time 1: pre test' and hour later time 2: post testinng proceedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Itshak Melzer, Dr principal investigator
Ben-gurion University of the Negev, Beer-Sheva, Israel
Zmir Shorer, Dr study chair
Soroka Medical Centar
Press Yossi, Prof study director
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ritalin in people with Attention Deficit Disorder With Hyperactivity, run by Soroka University Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural sway measures (time frame: Time 1: pre test' and hour later time 2: post testinng proceedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2011.