NCT05473377

Brief Summary

Assessment of the motor and sensory integrative functions (MSI) is a key component of an overall health and functional evaluation for school-aged children with intellectual disabilities (ID). An efficient and in-depth understanding of the students' motor and sensory integrative functions can help the school teachers implementing appropriate curriculum, monitoring the progress, managing the classroom, and further enhancing the overall learning for school-aged students with ID. Therefore, in this 2-year project, the investigators will develop a mobile application (APP) testing system for assessing Motor and Sensory Integrative Functions in School-aged Children with Intellectual Disabilities (MSI-ID) to overcome the aforementioned challenges. The investigators will determine whether the MSI-ID is efficient and psychometrically robust. Around150 to 200 school-aged children with ID will be recruited for this study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

December 29, 2023

Status Verified

December 1, 2023

Enrollment Period

7 months

First QC Date

July 5, 2022

Last Update Submit

December 27, 2023

Conditions

Outcome Measures

Primary Outcomes (10)

  • Bruininks-Oseretsky Test of Motor Proficiency- Second Edition

    The Bruininks-Oseretsky Test of Motor Proficiency- Second Edition assesses proficiency in four motor-area composites: fine manual control composite, manual coordination composite, body coordination composite, and strength and agility composite. The four composite scores are combined to yield a total motor composite score. The average age-adjusted scale scores for subtests are 15 (S.D. = 5), whereas composites are derived by summing the subtest scale scores and converting them to a quotient with a mean of 100 and a S.D. of 15. The minimum is 20, and the maximum is 80. Higher score means better outcome

    pretest: within the first month of the study

  • Bruininks-Oseretsky Test of Motor Proficiency- Second Edition

    The Bruininks-Oseretsky Test of Motor Proficiency- Second Edition assesses proficiency in four motor-area composites: fine manual control composite, manual coordination composite, body coordination composite, and strength and agility composite. The four composite scores are combined to yield a total motor composite score. The average age-adjusted scale scores for subtests are 15 (S.D. = 5), whereas composites are derived by summing the subtest scale scores and converting them to a quotient with a mean of 100 and a S.D. of 15. The minimum is 20, and the maximum is 80. Higher score means better outcome

    posttest:6 months after the pretest

  • Sensory Profile

    The Sensory Profile is a parent report measure of behaviors associated with abnormal responses to sensory stimuli for children 5-10 years of age. The Sensory Profile consists of 125 items grouped into three main sections: Sensory Processing, Modulation, and Behavioral and Emotional Responses. Items are scored from always (1) to never (5). The minimum is 125, and the maximum is 575. Higher scores indicate worse outcome. Scores at or above the mean are considered ''typical''; scores of 1 standard deviation below the mean for the typical reference sample are reported as a ''probable difference'', and scores at 2 standard deviations below the mean for the typical reference sample are reported as a ''definite difference''. Internal consistency of sections ranged from 0.47 to 0.90, and the standard error of measurement ranged from 1.13 to 2.81.90 The moderate correlations between the Sensory Profile and the School Function Assessment also supported its validity.

    pretest: within the first month of the study

  • Sensory Profile

    The Sensory Profile is a parent report measure of behaviors associated with abnormal responses to sensory stimuli for children 5-10 years of age. The Sensory Profile consists of 125 items grouped into three main sections: Sensory Processing, Modulation, and Behavioral and Emotional Responses. Items are scored from always (1) to never (5). The minimum is 125, and the maximum is 575. Higher scores indicate worse outcome. Scores at or above the mean are considered ''typical''; scores of 1 standard deviation below the mean for the typical reference sample are reported as a ''probable difference'', and scores at 2 standard deviations below the mean for the typical reference sample are reported as a ''definite difference''. Internal consistency of sections ranged from 0.47 to 0.90, and the SEM ranged from 1.13 to 2.81.90 The moderate correlations between the Sensory Profile and the School Function Assessment also supported its validity.

    posttest: 6 months after the pretest

  • Test of Visual Perceptual Skills, Third Edition

    The Test of Visual Perceptual Skills assesses visual perception for individuals aged 4-18 years 11 months in seven comprehensive subtests: visual discrimination, visual memory, visual spatial relationship, visual form constancy, visual sequential memory, visual figure-ground, and visual closure. The minimum is 55 and the maximum is 145, higher score means better outcome.

    pretest: within the first month of the study

  • Test of Visual Perceptual Skills, Third Edition

    The Test of Visual Perceptual Skills assesses visual perception for individuals aged 4-18 years 11 months in seven comprehensive subtests: visual discrimination, visual memory, visual spatial relationship, visual form constancy, visual sequential memory, visual figure-ground, and visual closure. The minimum is 55 and the maximum is 145, higher score means better outcome.

    posttest:6 months after the pretest

  • Cognitive/Behavioral Tasks Performance Scale (CBTPS) of School Function Assessment

    The School Function Assessment is a judgment-based assessment that measures a student's performance of functional tasks that support his or her participation in both academic and social school-related activities for students in grades kindergarten to 6th grade. The Cognitive/Behavioral Tasks Performance Scale (CBTPS) was used as an external criterion for clinically relevant change in the present study. The CBTPS include 121 items under 9 domains: functional communication, memory and understanding, following social conventions, compliance with adult directives and social rules, task/behavior completion, positive interaction, behavior regulation, personal care awareness, and safety. The activities are rated on a scale of 1 to 4, where 1 = does not perform, 2 = partial performance, 3 = inconsistent performance, and 4 = consistent performance. The minimum is 121, and the maximum is 484. Higher scores mean better outcome.

    pretest: within the first month of the study

  • Cognitive/Behavioral Tasks Performance Scale (CBTPS) of School Function Assessment

    The School Function Assessment is a judgment-based assessment that measures a student's performance of functional tasks that support his or her participation in both academic and social school-related activities for students in grades kindergarten to 6th grade. The Cognitive/Behavioral Tasks Performance Scale (CBTPS) was used as an external criterion for clinically relevant change in the present study. The CBTPS include 121 items under 9 domains: functional communication, memory and understanding, following social conventions, compliance with adult directives and social rules, task/behavior completion, positive interaction, behavior regulation, personal care awareness, and safety. The activities are rated on a scale of 1 to 4, where 1 = does not perform, 2 = partial performance, 3 = inconsistent performance, and 4 = consistent performance. The minimum is 121, and the maximum is 484. Higher scores mean better outcome.

    posttest: 6 months after the pretest

  • Physical Task Performance Scale (PTPS) of School Function Assessment

    The School Function Assessment is a judgment-based assessment that measures a student's performance of functional tasks that support his or her participation in both academic and social school-related activities for students in grades kindergarten to 6th grade. The Physical Task Performance Scale (PTPS) was used as an external criterion for clinically relevant change in the present study. The PTPS consists of 161 items (activities) divided into 12 domains including travel, maintaining and changing positions, recreational movement, manipulation with movement, using materials, set-up and cleanup, eating and drinking, hygiene, clothing management, up/down stairs, written work, and computer and equipment use. The activities are rated on a scale of 1-4 according to their performance level. The minimum is 161, and the maximum is 644. Higher scores mean better outcome.

    pretest: within the first month of the study

  • Physical Task Performance Scale (PTPS) of School Function Assessment

    The School Function Assessment is a judgment-based assessment that measures a student's performance of functional tasks that support his or her participation in both academic and social school-related activities for students in grades kindergarten to 6th grade. The Physical Task Performance Scale (PTPS) was used as an external criterion for clinically relevant change in the present study. The PTPS consists of 161 items (activities) divided into 12 domains including travel, maintaining and changing positions, recreational movement, manipulation with movement, using materials, set-up and cleanup, eating and drinking, hygiene, clothing management, up/down stairs, written work, and computer and equipment use. The activities are rated on a scale of 1-4 according to their performance level. The minimum is 161, and the maximum is 644. Higher scores mean better outcome.

    posttest: 6 months after the pretest

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

To ensure selection of children with major diagnoses of ID and age range in this study, a stratified sampling method will be used to recruit children for psychometric studies. Two stratifying variables will be considered. One is the severity of ID identified in ICD-10 (2 levels: borderline/mild, and moderate/severe). The other is the age band (5 strata: 6:0-6:11, 7:0-7:11, 8:0-10:11, 10:0-11:11, and 12:0-14:11 years).

You may qualify if:

  • age between 6 and 15 years
  • a diagnosis of ID determined by the board-certified physicians at local designated hospitals according to the standards put forth by the International Classification of Diseases, 10th revision, clinical modification (ICD-10 codes)
  • absence of serious emotional , behavioral disturbances or any other major disease affecting premorbid sensory processing and motor functions (e.g., cardiovascular diseases. muscular dystrophy, etc.)
  • participation in occupational therapy program at the time of research.

You may not qualify if:

  • Severe emotional disturbances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Occupational Therapy

Kaohsiung City, 807, Taiwan

Location

Related Publications (1)

  • Haley SM, Ni P, Ludlow LH, Fragala-Pinkham MA. Measurement precision and efficiency of multidimensional computer adaptive testing of physical functioning using the pediatric evaluation of disability inventory. Arch Phys Med Rehabil. 2006 Sep;87(9):1223-9. doi: 10.1016/j.apmr.2006.05.018.

Related Links

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Yee-Pay Wuang, PhD

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yee-Pay Wuang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2022

First Posted

July 25, 2022

Study Start

January 1, 2024

Primary Completion

July 31, 2024

Study Completion

December 31, 2024

Last Updated

December 29, 2023

Record last verified: 2023-12

Locations