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Effect of Ergonomic Classroom Furniture on the Printing Legibility of Elementary Students With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT00465686
Recruitment Status : Completed
First Posted : April 25, 2007
Last Update Posted : May 9, 2008
Sponsor:
Information provided by:
Holland Bloorview Kids Rehabilitation Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk) Device: ergonomic desk and chair (Q-Learn Desk) Phase 1

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Ergonomic Classroom Furniture and the Printing Legibility of Elementary School Students With CP
Study Start Date : February 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Device: ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk)
ergonomic school chair and desk adjusted to fit the child user as per the manufacturer's instructions
Other Name: Q-Learn Classic Chair and Q-Learn Desk
Device: ergonomic desk and chair (Q-Learn Desk)
child sits on chair and desk for 5 minutes, then provides handwriting sample at one desk, then repeats this for the other desk
Other Name: Q-Learn Desk



Primary Outcome Measures :
  1. Minnesota Handwriting Assessment [ Time Frame: 5-10 minutes ]


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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00465686


Locations
Canada, Ontario
Bloorview Research Institute, Bloorview Kids Rehab
Toronto, Ontario, Canada, M4G 1R8
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
Investigators
Principal Investigator: Stephen E Ryan, MSc, PEng Bloorview Research Institute, Bloorview Kids Rehab

Responsible Party: Stephen Ryan, MSc, PEng/Scientist, Bloorview Research Institute, Bloorview Kids Rehab
ClinicalTrials.gov Identifier: NCT00465686     History of Changes
Other Study ID Numbers: 06-010
First Posted: April 25, 2007    Key Record Dates
Last Update Posted: May 9, 2008
Last Verified: May 2008

Keywords provided by Holland Bloorview Kids Rehabilitation Hospital:
handwriting
child
primary school
posture
assistive device

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases