Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Differences in Muscle Activity Patterns and Graphical Product Quality in Children With Graphomotor Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501590
Recruitment Status : Completed
First Posted : July 17, 2015
Results First Posted : August 7, 2017
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Aviva Mimouni-Bloch, Loewenstein Hospital

Study Type Observational
Study Design Observational Model: Case-Control;   Time Perspective: Cross-Sectional
Condition Graphomotor Impairment
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Control
Hide Arm/Group Description

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).

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).

Period Title: Overall Study
Started 13 35
Completed 13 35
Not Completed 0 0
Arm/Group Title Study Control Total
Hide Arm/Group Description

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).

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).

Total of all reporting groups
Overall Number of Baseline Participants 13 35 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 35 participants 48 participants
<=18 years
13
 100.0%
35
 100.0%
48
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 35 participants 48 participants
4.9  (0.5) 5.9  (0.4) 5.4  (0.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 35 participants 48 participants
Female
4
  30.8%
18
  51.4%
22
  45.8%
Male
9
  69.2%
17
  48.6%
26
  54.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Israel Number Analyzed 13 participants 35 participants 48 participants
13 35 48
1.Primary Outcome
Title Normilized Muscle Activity
Hide Description 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.
Time Frame day1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Control
Hide Arm/Group Description:

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).

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).

Overall Number of Participants Analyzed 13 35
Median (Inter-Quartile Range)
Unit of Measure: % mvc
8.20
(4.75 to 18.78)
7.41
(5.58 to 9.69)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study, Control
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Control
Hide Arm/Group Description

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).

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).

All-Cause Mortality
Study Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/35 (0.00%) 
Hide Serious Adverse Events
Study Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/35 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/35 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Aviva Mimouni-Bloch
Organization: Head of The Pediatric Neurology and Developmental Unit
Phone: 97297709048
EMail: abloch@clalit.org.il
Layout table for additonal information
Responsible Party: Aviva Mimouni-Bloch, Loewenstein Hospital
ClinicalTrials.gov Identifier: NCT02501590    
Other Study ID Numbers: 22-14-LOE
First Submitted: July 8, 2015
First Posted: July 17, 2015
Results First Submitted: March 9, 2017
Results First Posted: August 7, 2017
Last Update Posted: April 30, 2019