Cerebral PalsyPhase 1NCT00465686
Effect of Ergonomic Classroom Furniture on the Printing Legibility of Elementary Students With Cerebral Palsy
A Phase 1 study testing ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk) and ergonomic desk and chair (Q-Learn Desk) in people with Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk) and ergonomic desk and chair (Q-Learn Desk)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2007to May 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- primary diagnosis of cerebral palsy
- functional status of Gross Motor Function Classification System Level I or II
Who cannot join
- genetic disorder;
- attention-deficit hyperactivity disorder; or,
- pervasive developmental disorder
Trial locations and contacts
1 site in 1 country.
Canada1 site
Bloorview Research Institute, Bloorview Kids Rehab
Toronto, Ontario, M4G 1R8
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk), ergonomic desk and chair (Q-Learn Desk)
- Keywords
- handwriting, child, primary school, posture, assistive device
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk)Device
Also called 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)Device
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk); Device: ergonomic desk and chair (Q-Learn Desk) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minnesota Handwriting Assessment
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2007 (estimated)
- Study startFeb 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Stephen E Ryan, MSc, PEng, Principal investigator, Bloorview Research Institute, Bloorview Kids Rehab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00465686
- Sponsor's protocol ID
- 06-010
- Status last verified
- May 2008
- First submitted
- 23 Apr 2007
- Last updated
- 9 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ergonomic Classroom Furniture and the Printing Legibility of Elementary School Students With CP
- ClinicalTrials.gov ID
- NCT00465686
- Acronym / sponsor ID
- 06-010
- Conditions
- Cerebral Palsy
- Keywords
- handwriting, child, primary school, posture, assistive device
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 25 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk), Device: ergonomic desk and chair (Q-Learn Desk) |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- primary diagnosis of cerebral palsy
- functional status of Gross Motor Function Classification System Level I or II
Key exclusion criteria (3 listed)
- genetic disorder;
- attention-deficit hyperactivity disorder; or,
- pervasive developmental disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk)Also: Q-Learn Classic Chair and Q-Learn Deskergonomic school chair and desk adjusted to fit the child user as per the manufacturer's instructions | Device | A |
| ergonomic desk and chair (Q-Learn Desk)Also: Q-Learn Deskchild sits on chair and desk for 5 minutes, then provides handwriting sample at one desk, then repeats this for the other desk | Device | A |
Primary outcome
Minnesota Handwriting Assessment
Time frame: 5-10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen E Ryan, MSc, PEng principal investigator
Bloorview Research Institute, Bloorview Kids Rehab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ergonomic chair and desk (Q-Learn Classic Chair and Q-Learn Desk) and ergonomic desk and chair (Q-Learn Desk) in people with Cerebral Palsy, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minnesota Handwriting Assessment (time frame: 5-10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2008.