NCT00465686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 9, 2008

Status Verified

May 1, 2008

Enrollment Period

1.2 years

First QC Date

April 23, 2007

Last Update Submit

May 5, 2008

Conditions

Cerebral Palsy

Keywords

handwritingchildprimary schoolpostureassistive device

Outcome Measures

Primary Outcomes (1)

  • Minnesota Handwriting Assessment

    5-10 minutes

Study Arms (1)

A

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

Interventions

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

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

Also known as: Q-Learn Classic Chair and Q-Learn Desk
A
ergonomic desk and chair (Q-Learn Desk)DEVICE

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

Also known as: Q-Learn Desk
A

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • primary diagnosis of cerebral palsy
  • functional status of Gross Motor Function Classification System Level I or II

You may not qualify if:

  • genetic disorder;
  • attention-deficit hyperactivity disorder; or,
  • pervasive developmental disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bloorview Research Institute, Bloorview Kids Rehab

Toronto, Ontario, M4G 1R8, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Stephen E Ryan, MSc, PEng

    Bloorview Research Institute, Bloorview Kids Rehab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 25, 2007

Study Start

February 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

May 9, 2008

Record last verified: 2008-05

Locations

CA(1)