Graphomotor ImpairmentNCT02501590
Differences in Muscle Activity Patterns and Graphical Product Quality in Children With Graphomotor Impairment
An observational study of Graphomotor Impairment, run by Loewenstein Hospital at 2 sites in Israel.
Trial summary
Drawing on a vertical surface, rather than horizontal (such as blackboard) is often used by occupational therapists as a way of developing fine motor control and visual motor integration in children. In healthy children no difference in graphical quality was shown between drawing on vertical or horizontal surfaces. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Graphomotor Impairment
- Type of treatment
- Pill or oral medicine
- How many people
- 48 participants
- Where
- 2 sitesIsrael
- Study dates
- Jun 2015to Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total of Forty five 4-6 years old children, referred to occupational therapy
Who may be able to join
None listed.
Who cannot join
- children in special education,
- any orthopedic or neurologic impairment,
- visual impairment that could not be corrected with glasses, or
- ability to understand and follow simple instructions, reported by the parents.
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Loewenstein hospital
Raanana
Loewenstein Rehabilitation Center
Raanana
About this study
Official title: Differences in Muscle Activity Patterns and Graphical Product Quality in Children With Graphomotor Impairment Copying and Tracing Activities on Horizontal or Vertical Surfaces
Drawing on a vertical surface, rather than horizontal (such as blackboard) is often used by occupational therapists as a way of developing fine motor control and visual motor integration in children. In healthy children no difference in graphical quality was shown between drawing on vertical or horizontal surfaces. However, this was not investigated in children with graphomotor impairments.
The goal of this study is to determine whether movements produced on a vertical surface differ in their performance level and muscle activation patterns compared to movements produced on a horizontal surface. The investigators predict that there would be a difference in the level of performance between the two surfaces.
Read the detailed description
Drawing on a vertical surface, such as a blackboard (rather than a horizontal surface) is often used by occupational therapists as a way of developing fine motor control and visual motor integration in children. While there is anecdotal evidence to support this intervention, preliminary results in healthy children showed no differences in graphical quality while drawing on vertical or horizontal surfaces. This however was not investigated in children with graphomotor impairments.
The goal of this study is to determine whether movements produced on a vertical surface differ in their performance level and muscle activation patterns compared to movements produced on a horizontal surface.
The investigators predict that the level of performance on the vertical surface will exceed the level of performance on the horizontal surface. Additionally, the investigators hypothesize that the proximal muscles will be more activated and fatigued (in longer tasks) while drawing on the vertical surface, while the distal muscle will be more activated and fatigued while drawing on the horizontal surface.
- Conditions
- Graphomotor Impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| study | After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child's dominant hand. The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing). | |
| control | After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child's dominant hand. The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normilized Muscle Activity
The maximal voluntary contraction (MVC) value for each muscle will be computed as the average of three peaks of the surface electromyography (sEMG) data, which differed by no more than 10% from one another. The mean root mean square (RMS) values of the sEMG data will be normalized by the MVC value for each muscle so that the value is presented by percentage.
Measured: day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Graphomotor ImpairmentStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aviva Mimouni-Bloch, Loewenstein Hospital
- Investigators
- Aviva Mimouni-Bloch, M.D, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501590
- Sponsor's protocol ID
- 22-14-LOE
- Status last verified
- Apr 2019
- First submitted
- 8 Jul 2015
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
McHale K, Cermak SA. Fine motor activities in elementary school: preliminary findings and provisional implications for children with fine motor problems. Am J Occup Ther. 1992 Oct;46(10):898-903. doi: 10.5014/ajot.46.10.898.
PubMed 1463061Schwellnus H, Carnahan H, Kushki A, Polatajko H, Missiuna C, Chau T. Effect of pencil grasp on the speed and legibility of handwriting after a 10-minute copy task in Grade 4 children. Aust Occup Ther J. 2012 Jun;59(3):180-7. doi: 10.1111/j.1440-1630.2012.01014.x.
PubMed 22690768Ratzon NZ, Efraim D, Bart O. A short-term graphomotor program for improving writing readiness skills of first-grade students. Am J Occup Ther. 2007 Jul-Aug;61(4):399-405. doi: 10.5014/ajot.61.4.399.
PubMed 17685172Yakimishyn JE, Magill-Evans J. Comparisons among tools, surface orientation, and pencil grasp for children 23 months of age. Am J Occup Ther. 2002 Sep-Oct;56(5):564-72. doi: 10.5014/ajot.56.5.564.
PubMed 12269511Wilson BN, Kaplan BJ, Crawford SG, Campbell A, Dewey D. Reliability and validity of a parent questionnaire on childhood motor skills. Am J Occup Ther. 2000 Sep-Oct;54(5):484-93. doi: 10.5014/ajot.54.5.484.
PubMed 11006808
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Muscle Activity Patterns and Graphical Product Quality in Children With Graphomotor Impairment Copying and Tracing Activities on Horizontal or Vertical Surfaces
- ClinicalTrials.gov ID
- NCT02501590
- Acronym / sponsor ID
- 22-14-LOE
- Conditions
- Graphomotor Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Posted 7 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Drawing on a vertical surface, rather than horizontal (such as blackboard) is often used by occupational therapists as a way of developing fine motor control and visual motor integration in children. In healthy children no difference in graphical quality was shown between drawing on vertical or horizontal surfaces. However, this was not investigated in children with graphomotor impairments.
The goal of this study is to determine whether movements produced on a vertical surface differ in their performance level and muscle activation patterns compared to movements produced on a horizontal surface. The investigators predict that there would be a difference in the level of performance between the two surfaces.
Detailed description
Drawing on a vertical surface, such as a blackboard (rather than a horizontal surface) is often used by occupational therapists as a way of developing fine motor control and visual motor integration in children. While there is anecdotal evidence to support this intervention, preliminary results in healthy children showed no differences in graphical quality while drawing on vertical or horizontal surfaces. This however was not investigated in children with graphomotor impairments.
The goal of this study is to determine whether movements produced on a vertical surface differ in their performance level and muscle activation patterns compared to movements produced on a horizontal surface.
The investigators predict that the level of performance on the vertical surface will exceed the level of performance on the horizontal surface. Additionally, the investigators hypothesize that the proximal muscles will be more activated and fatigued (in longer tasks) while drawing on the vertical surface, while the distal muscle will be more activated and fatigued while drawing on the horizontal surface.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study | – | –After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child's dominant hand. The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing). |
| control | – | –After the parents sign an informed consent form, they will fill out a demographic questionnaire. Than if the Beery VMI test was not yet administered, it would be performed, as well as the Developmental Coordination Disorder Questionnaire (DCD-Q). Surface electromyography electrodes will be placed on the Upper Trapezius, Extensor Carpi Radialis, and Biceps brachii of the child's dominant hand. The subject will perform 4 copying tasks and 2 tracing tasks on a tablet placed once on a horizontal surface (while sitting) and once on a vertical surface (while standing). |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total of Forty five 4-6 years old children, referred to occupational therapy
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- children in special education,
- any orthopedic or neurologic impairment,
- visual impairment that could not be corrected with glasses, or
- ability to understand and follow simple instructions, reported by the parents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Normilized Muscle Activity
Time frame: day1
The maximal voluntary contraction (MVC) value for each muscle will be computed as the average of three peaks of the surface electromyography (sEMG) data, which differed by no more than 10% from one another. The mean root mean square (RMS) values of the sEMG data will be normalized by the MVC value for each muscle so that the value is presented by percentage.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1463061McHale K, Cermak SA. Fine motor activities in elementary school: preliminary findings and provisional implications for children with fine motor problems. Am J Occup Ther. 1992 Oct;46(10):898-903. doi: 10.5014/ajot.46.10.898.
- Background: PubMed 22690768Schwellnus H, Carnahan H, Kushki A, Polatajko H, Missiuna C, Chau T. Effect of pencil grasp on the speed and legibility of handwriting after a 10-minute copy task in Grade 4 children. Aust Occup Ther J. 2012 Jun;59(3):180-7. doi: 10.1111/j.1440-1630.2012.01014.x.
- Background: PubMed 17685172Ratzon NZ, Efraim D, Bart O. A short-term graphomotor program for improving writing readiness skills of first-grade students. Am J Occup Ther. 2007 Jul-Aug;61(4):399-405. doi: 10.5014/ajot.61.4.399.
- Background: PubMed 12269511Yakimishyn JE, Magill-Evans J. Comparisons among tools, surface orientation, and pencil grasp for children 23 months of age. Am J Occup Ther. 2002 Sep-Oct;56(5):564-72. doi: 10.5014/ajot.56.5.564.
- Background: PubMed 11006808Wilson BN, Kaplan BJ, Crawford SG, Campbell A, Dewey D. Reliability and validity of a parent questionnaire on childhood motor skills. Am J Occup Ther. 2000 Sep-Oct;54(5):484-93. doi: 10.5014/ajot.54.5.484.
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.
Aviva Mimouni-Bloch, M.D principal investigator
Clalit Health Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Graphomotor Impairment, run by Loewenstein Hospital at 2 sites in Israel.
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 0 inclusion and 4 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 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Normilized Muscle Activity (time frame: day1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02501590, which also lists 5 linked publications.
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 30 Apr 2019.