Computerized Testing System for Measuring Motor and Sensory Integrative Functions in Intellectual Disabilities

Intellectual Disability Clinical Trial

Official title:

Developing a Computerized Testing System for Measuring Motor and Sensory Integrative Functions in School-aged Children With Intellectual Disabilities

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05473377
• Other study ID #: KMUHIRB-SV(I)-20210116
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Yee-Pay Wuang, PhD
• Phone: 07-3121101
• Email: yeepwu[@]kmu.edu.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Background and purposes: 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). The ability of students with ID to perform age-appropriate motor tasks and adaptive behaviors (end product of sensory integration) can help determine the long-term effects of special education curriculum/interventions and the quality of an overall school-based rehabilitation program. However, several challenges exist in measuring MSI for school-aged children with ID. First, most measures of MSI vary in content (domains), causing difficulty in the selection of relevant MSI measures. Second, most measures of MSI lack robust evidence of psychometric properties (e.g., reliability and responsiveness). Third, the minimal important difference (MID) and minimal detectable change (MDC) of most MSI measures for ID are largely unknown, which limits the interpretation of change scores in schools and clinical settings. Fourth, most MSI measures are time-consuming to administer, placing a burden of administration on both teachers/therapists and children. Finally, all the measures were developed in western countries and their use has not yet been validated for ID populations in Taiwan. 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. A validated and convenient computerized testing system is urgently needed. The Rasch model is useful in developing precise measures. Furthermore, a computerized adaptive testing (CAT) system can provide efficient measurements. Therefore, in this 3-year project, the investigators will develop a mobile 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. In our previous research (109WFD2110353), the investigators have established the item banks for 3 core domains of MSI (i.e., gross motor, fine motor, and sensory integration) and completed administering on 100 school-aged children with various levels of ID severity and age. Method: In the first year, the investigators will examine the model fitting of the established items and calibrate the item characteristics with Rasch modeling. Then, the MSI-ID (a tablet personal computer version) will be developed. The investigators will perform a simulation study to determine the performance (e.g., efficiency) of the MSI-ID. In the second year, the investigators will validate the MSI-ID. The tablet MSI-ID will be administered on 150 school-aged children with ID to validate its efficiency (i.e., feasibility and administration time) and psychometric properties (including reliability, validity, responsiveness, and minimal detectable change). A MSI-ID APP will be developed to facilitate the accessibility and utility and the testing system.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria:

• 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. Exclusion Criteria: -Severe emotional disturbances.

Related Conditions & MeSH terms

• Intellectual Disability

Locations

Country	Name	City	State
Taiwan	Dept of Occupational Therapy	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Measurement precision and efficiency of multidimensional computer adaptive testing of physical functioning using the pediatric evaluation of disability inventory.