Developmental Coordination Disorder Clinical Trial
Official title:
Reliability and Validity of a Computerized Tool to Assess Proprioception Among Children With Coordination Disorders
| Verified date | March 2020 |
| Source | Meir Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Coordination disorders are common among children that arrive to child development services.
Children with coordination disorders have impaired proprioceptive sensation and motor
planning. It is important to carry out a comprehensive assessment of these children in order
to design an appropriate and effective treatment. There is a lack of an objective and
standard assessment tools for proprioception and motor planning. Technology based assessment
tools might offer a solution, as they enable automated and accurate measurement. The purpose
of this study is to examine the validity and reliability of a new diagnostic computerized
kit, which was developed for assessment of proprioception and motor planning among children
with coordination disorders. The hypothesis includes:
1. Examine the construct validity of the new diagnostic computerized kit (the known group
procedure). Whether there is a difference in the outcomes between children with typical
development and children with coordination disorders.
2. Examine the construct validity of the new diagnostic computerized kit outcomes -
correlation with the following associated variables: (a) motor skills; (b) sensory
function; (c) participation in daily activities.
3. Examine of test-retest reliability of the new diagnostic computerized kit. Whether the
outcomes are stable in repeated measurements.
The participants will include fifty children between the ages of 5 to 7 years: 25 children
with coordination disorders (study group), and 25 children with typical development (control
group).
Each child will arrive for an evaluation meeting that includes: (a) the new diagnostic
computerized kit; (b) standard and routine tests for motor skills (Movement Assessment
Battery for Children-2-MABC-2, and two sub-test of the Beery-Buktenica developmental test of
visual-motor integration- Beery VMI). In addition, the children's parents will complete two
questionnaires: (a) Sensory Processing Measurement (SPM) for sensory function assessment; (b)
Participation in Childhood Occupations Questionnaire (PICO-Q) for daily participation
assessment. After two weeks, ten children from the control group will be evaluated once again
by the new diagnostic computerized kit for examine test-retest reliability.
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | June 1, 2019 |
| Est. primary completion date | January 1, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 5 Years to 7 Years |
| Eligibility |
Inclusion Criteria: - Children aged 5-7, insured by "Clalit Health Services", and their parents. Inclusion into groups will be done according to the DCDQ'07 Developmental Questionnaire (DCDQ'07). - Inclusion to study group: children in a waiting list for an occupational therapy evaluation due to difficulties in fine or gross motor difficulties in performing daily activities as self-treatment, Play and recreation, and suspicion of developmental delay and DCD. children are able to communicate and understand instructions in Hebrew, and their parents know the Hebrew language at the level of reading and writing. A score of 15-46 indicating DCD or suspected DCD in the DCDQ'07 questionnaire. - Inclusion into control group: healthy children with a typical development who are able to communicate and understand Hebrew instructions, and whose parents know the Hebrew language at the level of reading and writing. A score of 47-75 indicates that there is no DCD in the DCDQ'07 questionnaire. Exclusion Criteria: - Children with developmental syndromes such as autism, cerebral palsy, orthopedic or neurological diseases, including sensory systems, such as impaired vision, will not be included in the study (according to parents' questioning, if no information will be available in the medical record). Children who study in special education frames (according to parental questioning) will not be included in the study. Children who have previously been treated in occupational therapy will not included. |
| Country | Name | City | State |
|---|---|---|---|
| Israel | Orlansky,Clalit Health Services | Petach Tikva |
| Lead Sponsor | Collaborator |
|---|---|
| Jay Zuckerman |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Total time- outcome of the new diagnostic computerized kit - computerized thumb fingers matching test. | Time is one of the outcome measures of the computerized thumb fingers matching test, that is measured in a ratio scale. | Time duration for this test is 5 minutes. | |
| Primary | Standard Deviation (SD) of touch time- outcome of the new diagnostic computerized kit - computerized thumb fingers matching test. | Standard Deviation (SD) of touch time is one of the outcome measures of the computerized thumb fingers matching test, that is measured in a ratio scale by sensors of the touches. | Time duration for this test is 5 minutes. | |
| Primary | Correct sequence- outcome of the new diagnostic computerized kit - computerized thumb fingers matching test. | Correct sequence is one of the outcome measures of the computerized thumb fingers matching test, that is measured in a ratio scale by sensors of the touches. | Time duration for this test is 5 minutes. | |
| Secondary | Visual-motor integration outcome of the Beery-Buktenica developmental test of visual-motor integration (Beery VMI). | Visual-motor integration grade is measured in a ratio scale from the Beery VMI test. | Time duration for this test is 10 minutes. only one time point | |
| Secondary | Motor coordination outcome of the Beery-Buktenica developmental test of visual-motor integration (Beery VMI). | Motor coordination grade is measured in a ratio scale from the Beery VMI test. | Time duration for this test is 5 minutes. only one time point | |
| Secondary | Physical awareness outcome of the Sensory Processing Measurement (SPM). | Questionaire for the parents that is measured in a Likert scale. | Time duration for this questionaire is 20 minutes. only one time point | |
| Secondary | Balance and movement outcome of the Sensory Processing Measurement (SPM) . | Questionaire for the parents that is measured in a Likert scale. | Time duration for this questionaire is 20 minutes. only one time point | |
| Secondary | Planning and ideation outcome of the Sensory Processing Measurement (SPM). | Questionaire for the parents that is measured in a Likert scale. | Time duration for this questionaire is 20 minutes. only one time point | |
| Secondary | Total sensory systems outcome of the Sensory Processing Measurement (SPM). | Questionaire for the parents that is measured in a Likert scale. | Time duration for this questionaire is 20 minutes. only one time point | |
| Secondary | Difficulty in performance outcome of the Participation in Childhood Occupations Questionaire (PICO-Q). | Questionaire for the parents that is measured in a Likert scale. | Time duration for this questionaire is 15 minutes. only one time point | |
| Secondary | Frequency of performance outcome of the Participation in Childhood Occupations Questionaire (PICO-Q). | Questionaire for the parents that is measured in a Likert scale. | Time duration for this questionaire is 15 minutes. only one time point | |
| Secondary | Enjoyment outcome of the Participation in Childhood Occupations Questionaire (PICO-Q). | Questionaire for the parents that is measured in a Likert scale. | Time duration for this questionaire is 15 minutes. only one time point | |
| Secondary | Movement Assessment Battery for Children-2 (MABC-2)- general grade. | General grade of the subject's motor performance, that is measured in a ratio scale from the MABC-2. | Time duration for this test is 30 minutes. only one time point | |
| Secondary | Balance outcome of the Movement Assessment Battery for Children-2 (MABC-2). | Balance grade is measured in a ratio scale from the MABC-2. | Time duration for this test is 10 minutes. only one time point | |
| Secondary | Ball skills outcome of the Movement Assessment Battery for Children-2 (MABC-2). | Ball skills grade is measured in a ratio scale from the MABC-2. | Time duration for this test is 10 minutes. only one time point | |
| Secondary | Fine manual skills outcome of the Movement Assessment Battery for Children-2 (MABC-2). | Fine manual skills grade is measured in a ratio scale from the MABC-2. | Time duration for this test is 10 minutes. only one time point |
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