Wounds and InjuriesPhase 3NCT00213174
Study of Sand Versus Wood Chip Surfaces on School Playgrounds to Minimize Injury in School Children
A Phase 3 study testing school playgrounds in people with Wounds and Injuries and Closed Head Injury, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This study will compare children's injury rates (arm fracture, head injury and other injuries) when playing on playground equipment on granite sand versus wood fibre playing surfaces. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Wounds and Injuries, Closed Head Injury
- What is being tested?
- school playgrounds
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2005to not given
- Phase
- Phase 3
- 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 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- School children
- Ages 5-11
- Injured on falls from play equipment during supervised school hours
Who cannot join
- Children injured outside of supervised school hours
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Howard Andrew, MD, 416 813-6430, andrew.howard@sickkids.ca
Colin Macarthur, MD
About this study
Official title: School Playground Surfacing - A Randomized Prospective Comparison of Injury Rates on Sand Versus Wood Chip Surfaces
This study will compare children's injury rates (arm fracture, head injury and other injuries) when playing on playground equipment on granite sand versus wood fibre playing surfaces.
The hypothesis is that injury rates (arm fracture, head injury and other injuries) among school children are equal on granite sand and wood fibre playground surfaces.
- Conditions
- Wounds and Injuries, Closed Head Injury
- Being tested
- school playgrounds
- Keywords
- pediatrics, injury, arm fractures, trauma, playground surfaces, fractures
- Medical subject headings
- Wounds and Injuries, Head Injuries, Closed, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
school playgroundsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper extremity fracture rates
Secondary outcomes (3)
Fracture rates, upper extremity
Head injury rates
All injury rates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Andrew Howard, The Hospital for Sick Children
- Investigators
- Andrew W Howard, MD, MSc, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213174
- Sponsor's protocol ID
- 1000003531
- Other IDs
- CIHR: MCT-70318
- Status last verified
- Aug 2013
- First submitted
- 13 Sep 2005
- Last updated
- 15 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Playground Surfacing - A Randomized Prospective Comparison of Injury Rates on Sand Versus Wood Chip Surfaces
- ClinicalTrials.gov ID
- NCT00213174
- Acronym / sponsor ID
- 1000003531
- Conditions
- Wounds and Injuries, Closed Head Injury
- Keywords
- pediatrics, injury, arm fractures, trauma, playground surfaces, fractures
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2005
- First posted
- 21 Sep 2005 (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.
This study will compare children's injury rates (arm fracture, head injury and other injuries) when playing on playground equipment on granite sand versus wood fibre playing surfaces.
The hypothesis is that injury rates (arm fracture, head injury and other injuries) among school children are equal on granite sand and wood fibre playground surfaces.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- School children
- Ages 5-11
- Injured on falls from play equipment during supervised school hours
Key exclusion criteria (1 listed)
- Children injured outside of supervised school hours
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 |
|---|---|---|
| school playgrounds | Behavioural | – |
Primary outcome
Upper extremity fracture rates
3 secondary outcomes
Fracture rates, upper extremity
Head injury rates
All injury rates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
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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.
Andrew W Howard, MD, MSc principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing school playgrounds in people with Wounds and Injuries and Closed Head Injury, run by The Hospital for Sick Children at 1 site in Canada.
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 1 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: status not confirmed, as of the sponsor's last update on 15 Aug 2013. 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 Canada. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrew W Howard, MD, MSc (416-813-6430, andrew.howard@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremity fracture rates. 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 15 Aug 2013.