Clinical trial NCT05473377: Computerized Testing System for Measuring Motor and Sensory Integrative Functions in Intellectual Disabilities
Official title: Developing a Computerized Testing System for Measuring Motor and Sensory Integrative Functions in School-aged Children With Intellectual Disabilities
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intellectual Disability
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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).

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bruininks-Oseretsky Test of Motor Proficiency- Second Edition
timeFrame: pretest: within the first month of the study
measure: Bruininks-Oseretsky Test of Motor Proficiency- Second Edition
timeFrame: posttest：6 months after the pretest
measure: Sensory Profile
timeFrame: pretest: within the first month of the study
measure: Sensory Profile
timeFrame: posttest: 6 months after the pretest
measure: Test of Visual Perceptual Skills, Third Edition
timeFrame: pretest: within the first month of the study
measure: Test of Visual Perceptual Skills, Third Edition
timeFrame: posttest：6 months after the pretest
measure: Cognitive/Behavioral Tasks Performance Scale (CBTPS) of School Function Assessment
timeFrame: pretest: within the first month of the study
measure: Cognitive/Behavioral Tasks Performance Scale (CBTPS) of School Function Assessment
timeFrame: posttest: 6 months after the pretest
measure: Physical Task Performance Scale (PTPS) of School Function Assessment
timeFrame: pretest: within the first month of the study
measure: Physical Task Performance Scale (PTPS) of School Function Assessment
timeFrame: posttest: 6 months after the pretest
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Dept of Occupational Therapy
Study officials:
affiliation: Kaohsiung Medical University
name: Yee-Pay Wuang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.