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

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ClinicalTrials.gov Identifier: NCT03285776
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : December 21, 2017
Sponsor:
Information provided by (Responsible Party):
Jay Zuckerman, Meir Medical Center

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) two diagnostic sub-tests from the Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT2) adapted to a tablet; (c) 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.


Condition or disease
Developmental Coordination Disorder Developmental Dyspraxia Clumsy Child Syndrome

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Reliability and Validity of a Computerized Tool to Assess Proprioception and Motor Planning Among Children With Coordination Disorders
Actual Study Start Date : December 5, 2017
Estimated Primary Completion Date : January 1, 2019
Estimated Study Completion Date : June 1, 2019


Group/Cohort
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.



Primary Outcome Measures :
  1. Time outcome from the new diagnostic computerized kit - computerized maze test [ Time Frame: Time duration for this test is 5 minutes. ]
    Time is one of the outcome measures of the computerized maze test, that is measured in a ratio scale.

  2. Acceleration outcome from the new diagnostic computerized kit - computerized maze test [ Time Frame: Time duration for this test is 5 minutes. ]
    Acceleration is one of the outcome measures of the computerized maze test, that is measured in a ratio scale by an acceleration sensor. This sensor measures the acceleration of the subjects movment.

  3. Pressure outcome from the new diagnostic computerized kit - computerized maze test [ Time Frame: Time duration for this test is 5 minutes. ]
    Pressure is one of the outcome measures of the computerized maze test, that is measured in a ratio scale by a pressure sensor. This sensor measures the Pressure of the subjects grip.

  4. Time outcome of the new diagnostic computerized kit - computerized thumb fingers matching test. [ Time Frame: Time duration for this test is 5 minutes. ]
    Time is one of the outcome measures of the computerized thumb fingers matching test, that is measured in a ratio scale.

  5. Time between each touch (of finger and tumb) outcome of the new diagnostic computerized kit - computerized thumb fingers matching test. [ Time Frame: Time duration for this test is 5 minutes. ]
    Time between each touch (of finger and tumb) 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.

  6. Sequence outcome of the new diagnostic computerized kit - computerized thumb fingers matching test. [ Time Frame: Time duration for this test is 5 minutes. ]
    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.


Secondary Outcome Measures :
  1. Visual-motor integration outcome of the Beery-Buktenica developmental test of visual-motor integration (Beery VMI). [ Time Frame: Time duration for this test is 10 minutes. only one time point ]
    Visual-motor integration grade is measured in a ratio scale from the Beery VMI test.

  2. Motor precision outcome of the Beery-Buktenica developmental test of visual-motor integration (Beery VMI). [ Time Frame: Time duration for this test is 5 minutes. only one time point ]
    Motor precision grade is measured in a ratio scale from the Beery VMI test.

  3. social participation outcome of the Sensory Processing Measurement (SPM). [ Time Frame: Time duration for this questionaire is 20 minutes. only one time point ]
    Questionaire for the parents that is measured in a Likert scale.

  4. Vision outcome of the Sensory Processing Measurement (SPM). [ Time Frame: Time duration for this questionaire is 20 minutes. only one time point ]
    Questionaire for the parents that is measured in a Likert scale.

  5. Hearing outcome of the Sensory Processing Measurement (SPM). [ Time Frame: Time duration for this questionaire is 20 minutes. only one time point ]
    Questionaire for the parents that is measured in a Likert scale.

  6. Touch outcome of the Sensory Processing Measurement (SPM). [ Time Frame: Time duration for this questionaire is 20 minutes. only one time point ]
    Questionaire for the parents that is measured in a Likert scale.

  7. Physical awareness outcome of the Sensory Processing Measurement (SPM). [ Time Frame: Time duration for this questionaire is 20 minutes. only one time point ]
    Questionaire for the parents that is measured in a Likert scale.

  8. Balance and movement outcome of the Sensory Processing Measurement (SPM) . [ Time Frame: Time duration for this questionaire is 20 minutes. only one time point ]
    Questionaire for the parents that is measured in a Likert scale.

  9. Planning and ideation outcome of the Sensory Processing Measurement (SPM). [ Time Frame: Time duration for this questionaire is 20 minutes. only one time point ]
    Questionaire for the parents that is measured in a Likert scale.

  10. Difficulty in performance outcome of the Participation in Childhood Occupations Questionaire (PICO-Q). [ Time Frame: Time duration for this questionaire is 15 minutes. only one time point ]
    Questionaire for the parents that is measured in a Likert scale.

  11. Frequency of performance outcome of the Participation in Childhood Occupations Questionaire (PICO-Q). [ Time Frame: Time duration for this questionaire is 15 minutes. only one time point ]
    Questionaire for the parents that is measured in a Likert scale.

  12. Enjoyment outcome of the Participation in Childhood Occupations Questionaire (PICO-Q). [ Time Frame: Time duration for this questionaire is 15 minutes. only one time point ]
    Questionaire for the parents that is measured in a Likert scale.

  13. Copy shapes outcome from the Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT2) adapted to a tablet- first sub-test. [ Time Frame: Time duration for this test is 5 minutes. only one time point ]
    Copy shapes grade is measured in a ratio scale from the BOT2 adapted to a tablet- first sub-test.

  14. Graphic accuracy outcome from the Bruininks-Oseretsky Test of Motor Proficiency Second Edition (BOT2) adapted to a tablet- second sub-test. [ Time Frame: Time duration for this test is 5 minutes. only one time point ]
    Graphic accuracy grade is measured in a ratio scale from the BOT2 adapted to a tablet- second sub-test.

  15. Movement Assessment Battery for Children-2 (MABC-2)- general grade. [ Time Frame: Time duration for this test is 30 minutes. only one time point ]
    General grade of the subject's motor performance, that is measured in a ratio scale from the MABC-2.

  16. Balance outcome of the Movement Assessment Battery for Children-2 (MABC-2). [ Time Frame: Time duration for this test is 10 minutes. only one time point ]
    Balance grade is measured in a ratio scale from the MABC-2.

  17. Ball skills outcome of the Movement Assessment Battery for Children-2 (MABC-2). [ Time Frame: Time duration for this test is 10 minutes. only one time point ]
    Ball skills grade is measured in a ratio scale from the MABC-2.

  18. Fine manual skills outcome of the Movement Assessment Battery for Children-2 (MABC-2). [ Time Frame: Time duration for this test is 10 minutes. only one time point ]
    Fine manual skills grade is measured in a ratio scale from the MABC-2.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 7 Years   (Child)
Sexes Eligible for Study:   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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285776


Contacts
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Contact: Artal Furmansky, BA 972547916355 artalfor@gmail.com

Locations
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Israel
Orlansky,Clalit Health Services Recruiting
Petach Tikva, Israel
Contact: Artal Furmansky, BOT       artalfor@gmail.com   
Sponsors and Collaborators
Jay Zuckerman
Investigators
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Principal Investigator: jay zuckerman, DR Israel: Clalit Health Services

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Responsible Party: Jay Zuckerman, Developmental doctor and director of the Children's Development Center, Meir Medical Center
ClinicalTrials.gov Identifier: NCT03285776     History of Changes
Other Study ID Numbers: MMC170038-17kCTIL
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Ataxia
Motor Skills Disorders
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders