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

Cerebral Palsy Clinical Trial

Official title:

Ergonomic Classroom Furniture and the Printing Legibility of Elementary School Students With CP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465686
• Other study ID #: 06-010
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2007
• Last updated: May 5, 2008
• Start date: February 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Holland Bloorview Kids Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 8 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Bloorview Research Institute, Bloorview Kids Rehab	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Holland Bloorview Kids Rehabilitation Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minnesota Handwriting Assessment		5-10 minutes	No