Clinical trial NCT05451238: A Computerized Testing System for Measuring Motor and Sensory Integrative Functions in Children
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: UNKNOWN
Conditions: Intellectual Disability
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: school-aged children with different level of intellectual disabilities

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). 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.We will develop item banks for 3 core domains of MSI (i.e., gross motor, fine motor, and sensory integration) for school-aged children with ID. About 200-250 participants will be recruited.

Detailed description: 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, we will develop a Computerized Testing system for measuring Motor and Sensory Integrative Functioning in School-aged Children with Intellectual Disabilities (MSI-ID) to overcome the aforementioned challenges. We will determine whether the MSI-ID is efficient and psychometrically robust.

Method: We will develop item banks for 3 core domains of MSI (i.e., gross motor, fine motor, and sensory integration) for school-aged children with ID. We will select the 3 domains based on both core elements of a child's overall function and priorities of caregivers/teachers as determined in our preliminary study. We will construct 100 items for each domain based on focus group interviews of teachers / caregivers of students with ID and therapists, related theories and assessments, and suggestions from the experts. Then we will administer each item on 100 school-aged children with various levels of ID severity and age.

Eligibility criteria: Inclusion Criteria:

1. ages between 6 and 15 years; (2) 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); and (3) absence of serious emotional , behavioral disturbances or any other major disease affecting premorbid sensory processing and motor functions (e.g., muscular dystrophy).

Exclusion Criteria:

* None

Primary outcomes:
measure: BOT-2
timeFrame: Baseline (pretest)
measure: Jebsen-Taylor Hand Function Test
timeFrame: Baseline (pretest)
measure: TVPS-4
timeFrame: Baseline (pretest)
measure: Sensory Profile
timeFrame: Baseline (pretest)
measure: Vineland Adaptive Behavior Scale-Chinese Version
timeFrame: Baseline (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, Dumas HM, Fragala-Pinkham MA, Hambleton RK, Montpetit K, Bilodeau N, Gorton GE, Watson K, Tucker CA. Measuring global physical health in children with cerebral palsy: illustration of a multidimensional bi-factor model and computerized adaptive testing. Qual Life Res. 2009 Apr;18(3):359-70. doi: 10.1007/s11136-009-9447-5. Epub 2009 Feb 17.