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

NCT ID: NCT00465686

Last Updated: 2008-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Palsy

Keywords

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handwriting child primary school posture assistive device

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A

Group Type EXPERIMENTAL

ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk)

Intervention Type DEVICE

ergonomic school chair and desk adjusted to fit the child user as per the manufacturer's instructions

ergonomic desk and chair (Q-Learn Desk)

Intervention Type DEVICE

child sits on chair and desk for 5 minutes, then provides handwriting sample at one desk, then repeats this for the other desk

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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Q-Learn Classic Chair and Q-Learn Desk Q-Learn Desk

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Holland Bloorview Kids Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bloorview Research Institute, Bloorview Kids Rehab

Principal Investigators

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Stephen E Ryan, MSc, PEng

Role: PRINCIPAL_INVESTIGATOR

Bloorview Research Institute, Bloorview Kids Rehab

Locations

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Bloorview Research Institute, Bloorview Kids Rehab

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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06-010

Identifier Type: -

Identifier Source: org_study_id