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Clinical Trial Summary

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.


Clinical Trial Description

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 new diagnostic computerized kit consists a computerized thumb- fingers matching test (for proprioception).

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) in a waiting list for an occupational therapy evaluation (in Orlansky Children's Development Center, Dan -Petah Tikva Region, Clalit Health Services), and 25 children with typical development (control group).

The participants will be recruited by a convenience sample. Participation in the study will be offered by telephone to parents of children who may meet the inclusion /exclusion criteria. For the study group the recruitment will be to children in a waiting list for an occupational therapy evaluation (in Orlansky Children's Development Center). For the control group, the recruitment will be by a snowball sample (a friend brings a friend), through acquaintances of the investigators. Children whose parents agree to participate in the study will attend one meeting, accompanied by at least one parent. At the beginning of the meeting, the parents will receive a detailed explanation about the purpose and the study process. The new diagnostic computerized kit will be presented and explained how to use it. Parents will be assured total privacy. In addition, parents of children from the study group will be told that their child's medical record will be used to ensure inclusion and exclusion criteria. Parents who express their consent to participate in the study will sign an informed consent form and then complete a demographic questionnaire and a screening questionnaire. Children that will be find suitable for the study will Be evaluated by: (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.

Analysis of the data will be done using the SPSS version 32. Descriptive statistics will be used for description of the population and the variables. Shapiro-wilks test will be used to examine the type of distribution of the dependent variables. According to the type of distribution will use t-test for two independent samples or Mann-Whitney test to examine the differences between groups (hypothesis 1). Pearson Correlation Coefficient test or Spearman's Rank Correlation Coefficient test will be used to examine correlation between the outcomes of the assessment tools (hypothesis 2 and 3). The significance level for all the statistical tests will be p<0.05. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03285776
Study type Observational
Source Meir Medical Center
Contact
Status Completed
Phase
Start date December 5, 2017
Completion date June 1, 2019

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