Development Coordination DisorderNCT01130038
Characteristic of Play: Comparison Between Children With Development Coordination Disorder ( DCD) and Children With Typical Development
An observational study of Development Coordination Disorder, run by Meir Medical Center at 1 site in Israel.
Trial summary
There will be found differences in the issue of characteristic of play between Children with Development Coordination Disorder and Children with Typical Development. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Development Coordination Disorder
- How many people
- 64 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2010to Jul 2011
- Phase
- Observational
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 4-6 years with Development Coordination Disorder ( DCD) and Children with Typical Development (controlled group)
Who may be able to join
- Children with proper( age expected) intelligence and IQ level
- Study in regular education system
- The DCD diagnosis must be confirmed by a pediatrician
Who cannot join
- Score above 9 in the Movement Assessment Battery test for Children
- Score below 3.83 in Children Activity Scale for Parents
- routinely take medication
- any physical limitations
- neurologic and/or muscle disease
- any significant hearing and/ or vision limitations
Trial locations and contacts
1 site in 1 country.
About this study
There will be found differences in the issue of characteristic of play between Children with Development Coordination Disorder and Children with Typical Development.
- Conditions
- Development Coordination Disorder
- Keywords
- Characteristic of play, DCD, children, Typical Development, Whether there are any differences in the issue of Characteristic of play between Children with DCD and Children with Typical Development
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with DCD and Typical Development | Not described | |
| Children with DCD | 2 groups Children with DCD and Typical Development |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development Coordination DisorderStudies 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
- Observational
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130038
- Sponsor's protocol ID
- 032/2010k
- Status last verified
- Aug 2011
- First submitted
- 24 May 2010
- Last updated
- 30 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristic of Play: Comparison Between Children With Development Coordination Disorder ( DCD) and Children With Typical Development
- ClinicalTrials.gov ID
- NCT01130038
- Acronym / sponsor ID
- 032/2010k
- Conditions
- Development Coordination Disorder
- Keywords
- Characteristic of play, DCD, children, Typical Development, Whether there are any differences in the issue of Characteristic of play between Children with DCD and Children with Typical Development
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 25 May 2010 (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.
There will be found differences in the issue of characteristic of play between Children with Development Coordination Disorder and Children with Typical Development.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with DCD and Typical Development | – | – |
| Children with DCD | – | –2 groups Children with DCD and Typical Development |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 4-6 years with Development Coordination Disorder ( DCD) and Children with Typical Development (controlled group)
Key inclusion criteria (3 listed)
- Children with proper( age expected) intelligence and IQ level
- Study in regular education system
- The DCD diagnosis must be confirmed by a pediatrician
Key exclusion criteria (6 listed)
- Score above 9 in the Movement Assessment Battery test for Children
- Score below 3.83 in Children Activity Scale for Parents
- routinely take medication
- any physical limitations
- neurologic and/or muscle disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 30 Aug 2011.
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Wearable Sensor Toolkit for Infant Motor Development
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Development Coordination Disorder, run by Meir 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 6 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 30 Aug 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.
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 30 Aug 2011.