Clinical trial NCT03285776: Reliability and Validity of a Computerized Tool to Assess Proprioception Among Children With Coordination Disorders
Official title: Reliability and Validity of a Computerized Tool to Assess Proprioception Among Children With Coordination Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Coordination Disorder
Developmental Dyspraxia
Clumsy Child Syndrome
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 52
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will include fifty children between the ages of 5 to 7 years:

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

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total time- outcome of the new diagnostic computerized kit - computerized thumb fingers matching test.
timeFrame: Time duration for this test is 5 minutes.
measure: Standard Deviation (SD) of touch time- outcome of the new diagnostic computerized kit - computerized thumb fingers matching test.
timeFrame: Time duration for this test is 5 minutes.
measure: Correct sequence- outcome of the new diagnostic computerized kit - computerized thumb fingers matching test.
timeFrame: Time duration for this test is 5 minutes.
Secondary outcomes:
measure: Visual-motor integration outcome of the Beery-Buktenica developmental test of visual-motor integration (Beery VMI).
timeFrame: Time duration for this test is 10 minutes. only one time point
measure: Motor coordination outcome of the Beery-Buktenica developmental test of visual-motor integration (Beery VMI).
timeFrame: Time duration for this test is 5 minutes. only one time point
measure: Physical awareness outcome of the Sensory Processing Measurement (SPM).
timeFrame: Time duration for this questionaire is 20 minutes. only one time point
measure: Balance and movement outcome of the Sensory Processing Measurement (SPM) .
timeFrame: Time duration for this questionaire is 20 minutes. only one time point
measure: Planning and ideation outcome of the Sensory Processing Measurement (SPM).
timeFrame: Time duration for this questionaire is 20 minutes. only one time point
measure: Total sensory systems outcome of the Sensory Processing Measurement (SPM).
timeFrame: Time duration for this questionaire is 20 minutes. only one time point
measure: Difficulty in performance outcome of the Participation in Childhood Occupations Questionaire (PICO-Q).
timeFrame: Time duration for this questionaire is 15 minutes. only one time point
measure: Frequency of performance outcome of the Participation in Childhood Occupations Questionaire (PICO-Q).
timeFrame: Time duration for this questionaire is 15 minutes. only one time point
measure: Enjoyment outcome of the Participation in Childhood Occupations Questionaire (PICO-Q).
timeFrame: Time duration for this questionaire is 15 minutes. only one time point
measure: Movement Assessment Battery for Children-2 (MABC-2)- general grade.
timeFrame: Time duration for this test is 30 minutes. only one time point
measure: Balance outcome of the Movement Assessment Battery for Children-2 (MABC-2).
timeFrame: Time duration for this test is 10 minutes. only one time point
measure: Ball skills outcome of the Movement Assessment Battery for Children-2 (MABC-2).
timeFrame: Time duration for this test is 10 minutes. only one time point
measure: Fine manual skills outcome of the Movement Assessment Battery for Children-2 (MABC-2).
timeFrame: Time duration for this test is 10 minutes. only one time point
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Orlansky,Clalit Health Services
Study officials:
affiliation: Israel: Clalit Health Services
name: jay zuckerman, DR
role: PRINCIPAL_INVESTIGATOR
References: