- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00465686
Effect of Ergonomic Classroom Furniture on the Printing Legibility of Elementary Students With Cerebral Palsy
May 5, 2008 updated by: Holland Bloorview Kids Rehabilitation Hospital
Ergonomic Classroom Furniture and the Printing Legibility of Elementary School Students With CP
The purpose of this pilot study is to gather the data needed to do a larger research study to determine whether children with cerebral palsy print better sitting at an ergonomically-designed, custom-fitted school desk or at an oversized, standard school desk.
Study Overview
Status
Completed
Conditions
Detailed Description
This pilot study will allow us to gather information for a high-quality randomized controlled trial to study the efficacy of ergonomic school furniture as a remedial handwriting intervention for young students with cerebral palsy.
We will conduct the study in two parts.
In the first part, 30 children with Gross Motor Function Classification System (GMFCS) Level I and II cerebral palsy will each provide manuscript handwriting samples using two different school furniture configurations.
A blinded assessor will score the legibility of handwriting samples using the Minnesota Handwriting Assessment (MHA) as a primary outcome measure.
In the second part, seven occupational therapy experts will attend a focus group to help us determine the minimal clinically important difference score for the MHA.
We will use the data collected to determine the sample size requirements for a proposed randomized controlled trial.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4G 1R8
- Bloorview Research Institute, Bloorview Kids Rehab
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 8 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- primary diagnosis of cerebral palsy
- functional status of Gross Motor Function Classification System Level I or II
Exclusion Criteria:
- genetic disorder;
- attention-deficit hyperactivity disorder; or,
- pervasive developmental disorder
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A
|
ergonomic school chair and desk adjusted to fit the child user as per the manufacturer's instructions
Other Names:
child sits on chair and desk for 5 minutes, then provides handwriting sample at one desk, then repeats this for the other desk
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Minnesota Handwriting Assessment
Time Frame: 5-10 minutes
|
5-10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stephen E Ryan, MSc, PEng, Bloorview Research Institute, Bloorview Kids Rehab
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
April 23, 2007
First Submitted That Met QC Criteria
April 23, 2007
First Posted (Estimate)
April 25, 2007
Study Record Updates
Last Update Posted (Estimate)
May 9, 2008
Last Update Submitted That Met QC Criteria
May 5, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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