Trial Outcomes & Findings for Differences in Muscle Activity Patterns and Graphical Product Quality in Children With Graphomotor Impairment (NCT NCT02501590)

Last Updated: 2019-04-30

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

48 participants

Primary outcome timeframe

day1

Results posted on

2019-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	13	35
Overall Study COMPLETED	13	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study n=13 Participants 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 n=35 Participants 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 n=48 Participants Total of all reporting groups
Age, Categorical <=18 years	13 Participants n=13 Participants	35 Participants n=35 Participants	48 Participants n=48 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=13 Participants	0 Participants n=35 Participants	0 Participants n=48 Participants
Age, Categorical >=65 years	0 Participants n=13 Participants	0 Participants n=35 Participants	0 Participants n=48 Participants
Age, Continuous	4.9 years STANDARD_DEVIATION 0.5 • n=13 Participants	5.9 years STANDARD_DEVIATION 0.4 • n=35 Participants	5.4 years STANDARD_DEVIATION 0.45 • n=48 Participants
Sex: Female, Male Female	4 Participants n=13 Participants	18 Participants n=35 Participants	22 Participants n=48 Participants
Sex: Female, Male Male	9 Participants n=13 Participants	17 Participants n=35 Participants	26 Participants n=48 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Israel	13 participants n=13 Participants	35 participants n=35 Participants	48 participants n=48 Participants

PRIMARY outcome

Timeframe: day1

Outcome measures

Outcome measures
Measure	Study n=13 Participants 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 n=35 Participants 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).
Normilized Muscle Activity	8.20 % mvc Interval 4.75 to 18.78	7.41 % mvc Interval 5.58 to 9.69

Adverse Events

Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aviva Mimouni-Bloch

Head of The Pediatric Neurology and Developmental Unit

Phone: 97297709048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place