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CompletedNCT03285776Updated Apr 2, 2020

Reliability and Validity of a Computerized Tool to Assess Proprioception Among Children With Coordination Disorders

An observational study in Developmental Coordination Disorder, Developmental Dyspraxia and Clumsy Child Syndrome, sponsored by Jay Zuckerman. Completed at 1 site in Israel. Open to participants aged 5 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-02.

Sponsored by Jay Zuckerman · Observational

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Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
52
Ages
5 Years to 7 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Developmental Coordination Disorder
  • Developmental Dyspraxia
  • Clumsy Child Syndrome
03

In context

Motor Skills Disorders

104 studies on the registry are indexed under Motor Skills Disorders; 28 are open to participants now.

This study's enrollment of 52 is below the median of 84 across 27 observational studies indexed under Motor Skills Disorders.

Browse Motor Skills Disorders studies →

Lead sponsor

This is the only study on the registry with Jay Zuckerman as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
52 participants (actual)
Patient registry
No

Groups and cohorts

  • Study group

    Children with coordination disorder between the ages of 5 to 7 years.

  • control group

    children with typical development between the ages of 5 to 7 years.

06

What researchers measure

Primary outcomes

  1. 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 frame: Time duration for this test is 5 minutes.

  2. 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 frame: Time duration for this test is 5 minutes.

  3. 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 frame: Time duration for this test is 5 minutes.

Secondary outcomes

  1. 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 frame: Time duration for this test is 10 minutes. only one time point

  2. 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 frame: Time duration for this test is 5 minutes. only one time point

  3. Physical awareness outcome of the Sensory Processing Measurement (SPM).

    Questionaire for the parents that is measured in a Likert scale.

    Time frame: Time duration for this questionaire is 20 minutes. only one time point

  4. Balance and movement outcome of the Sensory Processing Measurement (SPM) .

    Questionaire for the parents that is measured in a Likert scale.

    Time frame: Time duration for this questionaire is 20 minutes. only one time point

  5. Planning and ideation outcome of the Sensory Processing Measurement (SPM).

    Questionaire for the parents that is measured in a Likert scale.

    Time frame: Time duration for this questionaire is 20 minutes. only one time point

  6. Total sensory systems outcome of the Sensory Processing Measurement (SPM).

    Questionaire for the parents that is measured in a Likert scale.

    Time frame: Time duration for this questionaire is 20 minutes. only one time point

  7. 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 frame: Time duration for this questionaire is 15 minutes. only one time point

  8. 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 frame: Time duration for this questionaire is 15 minutes. only one time point

  9. Enjoyment outcome of the Participation in Childhood Occupations Questionaire (PICO-Q).

    Questionaire for the parents that is measured in a Likert scale.

    Time frame: Time duration for this questionaire is 15 minutes. only one time point

  10. 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 frame: Time duration for this test is 30 minutes. only one time point

  11. 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 frame: Time duration for this test is 10 minutes. only one time point

  12. 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 frame: Time duration for this test is 10 minutes. only one time point

  13. 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 frame: Time duration for this test is 10 minutes. only one time point

07

Study locations

1 site
  • Orlansky,Clalit Health Services
    Petach Tikva, Israel
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in Jan 2019, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2017
First posted
Sep 18, 2017
StartActual
Dec 5, 2017
Primary completionActual
Jan 1, 2019
CompletionActual
Jun 1, 2019
Last update
Apr 2, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03285776
Lead sponsor
Jay Zuckerman
Responsible party
Jay Zuckerman (Developmental doctor and director of the Children's Development Center, Meir Medical Center) — Sponsor-investigator
First posted
Sep 18, 2017
Start date
Dec 5, 2017
Primary completion
Jan 1, 2019
Completion
Jun 1, 2019
Last update
Apr 2, 2020

Study contacts

jay zuckerman, DR
principal investigator · Israel: Clalit Health Services

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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