Intellectual DisabilityNCT05451238
A Computerized Testing System for Measuring Motor and Sensory Integrative Functions in Children
An observational study of Intellectual Disability, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Intellectual Disability
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Child
Study population: school-aged children with different level of intellectual disabilities
Who may be able to join
- 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).
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing a Computerized Testing System for Measuring Motor and Sensory Integrative Functions in School-aged Children With Intellectual Disabilities
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.
Read the 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.
- Conditions
- Intellectual Disability
- Medical subject headings
- Intellectual Disability
What is being measured
The primary outcome is the main question the study is designed to answer.
BOT-2
The BOT-2 assesses proficiency in four motor-area composites: fine manual control composite, manual coordination composite, body coordination composite, and strength and agility composite. 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.
Measured: Baseline (pretest)
Jebsen-Taylor Hand Function Test
The JTHFT is a quick and reliable measure of hand functioning incorporating 7 simulated tasks of activities of daily living (ADL).The tasks are: stacking, simulated page-turning, simulated feeding, picking up small objects, lifting large and lightweight object, lifting heavy object, and writing (copying). All tasks were timed and three scores were generated. A JTHFT- object score was the total time (seconds) taken to perform all 6 tasks except for writing for dominant and non-dominant hand, respectively. A JTHFT- writing score was the time spent (seconds) to complete a writing task for the dominant hand. Excellent reliabilities was reported in adults and typically developing children, and this assessment has also been utilized to exam the uni-manual capabilities in children with cerebral palsy and other motor dysfunctions
Measured: Baseline (pretest)
TVPS-4
The TVPS-4 is a motor-free and individually administered test to evaluate the comprehensive visual perceptual functions for individuals aged 5-21. The TVPS-4 comprised 7 tests: visual discrimination, visual memory, spatial relationship, form constancy, sequential memory, visual figure- ground, and visual closure. The TVPS-4 has excellent reliabilities evidence and concurrent validities with other similar tests
Measured: Baseline (pretest)
Sensory Profile
The SP is a parent report measure of behaviors associated with abnormal responses to sensory stimuli for children 5-10 years of age. The SP 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), with higher scores indicating more impairment. The total score of each section is the best indicator of overall sensory dysfunction. The SP provides published cut-off scores. 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''.
Measured: Baseline (pretest)
Vineland Adaptive Behavior Scale-Chinese Version
The VABS-C was the Chinese version of the Vineland Adaptive Behavior Scale23 and was used in individuals aged 0 to 18 years-11 months. This assessment measures age-related adaptive skills essential for personal and social competencies. This 577-item measure included four domains: motor skills (gross, fine), communication (written, expressive, receptive,), daily living skills (community domestic, personal,), and socialization skills (coping skills, interpersonal relationships, play and leisure time)
Measured: Baseline (pretest)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Aug 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yee-Pay Wuang, PhD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451238
- Sponsor's protocol ID
- KMUHIRB-SV(II)-20190087
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 19221892Chou YC, Chen YW, Wuang YP. Reliability, Validity, and Responsiveness of the Visual Perceptual and Fine Motor Function Tests in School-Aged Children With Mild Intellectual Disabilities. Occup Ther Int. 2026;2026(1):e5560931. doi: 10.1155/oti/5560931.
PubMed 42083120
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Computerized Testing System for Measuring Motor and Sensory Integrative Functions in School-aged Children With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT05451238
- Acronym / sponsor ID
- KMUHIRB-SV(II)-20190087
- Conditions
- Intellectual Disability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- school-aged children with different level of intellectual disabilities
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BOT-2
Time frame: Baseline (pretest)
The BOT-2 assesses proficiency in four motor-area composites: fine manual control composite, manual coordination composite, body coordination composite, and strength and agility composite. 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.
Jebsen-Taylor Hand Function Test
Time frame: Baseline (pretest)
The JTHFT is a quick and reliable measure of hand functioning incorporating 7 simulated tasks of activities of daily living (ADL).The tasks are: stacking, simulated page-turning, simulated feeding, picking up small objects, lifting large and lightweight object, lifting heavy object, and writing (copying). All tasks were timed and three scores were generated. A JTHFT- object score was the total time (seconds) taken to perform all 6 tasks except for writing for dominant and non-dominant hand, respectively. A JTHFT- writing score was the time spent (seconds) to complete a writing task for the dominant hand. Excellent reliabilities was reported in adults and typically developing children, and this assessment has also been utilized to exam the uni-manual capabilities in children with cerebral palsy and other motor dysfunctions
TVPS-4
Time frame: Baseline (pretest)
The TVPS-4 is a motor-free and individually administered test to evaluate the comprehensive visual perceptual functions for individuals aged 5-21. The TVPS-4 comprised 7 tests: visual discrimination, visual memory, spatial relationship, form constancy, sequential memory, visual figure- ground, and visual closure. The TVPS-4 has excellent reliabilities evidence and concurrent validities with other similar tests
Sensory Profile
Time frame: Baseline (pretest)
The SP is a parent report measure of behaviors associated with abnormal responses to sensory stimuli for children 5-10 years of age. The SP 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), with higher scores indicating more impairment. The total score of each section is the best indicator of overall sensory dysfunction. The SP provides published cut-off scores. 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''.
Vineland Adaptive Behavior Scale-Chinese Version
Time frame: Baseline (pretest)
The VABS-C was the Chinese version of the Vineland Adaptive Behavior Scale23 and was used in individuals aged 0 to 18 years-11 months. This assessment measures age-related adaptive skills essential for personal and social competencies. This 577-item measure included four domains: motor skills (gross, fine), communication (written, expressive, receptive,), daily living skills (community domestic, personal,), and socialization skills (coping skills, interpersonal relationships, play and leisure time)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Results publication: PubMed 19221892Haley 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.
- Derived from this study: PubMed 42083120Chou YC, Chen YW, Wuang YP. Reliability, Validity, and Responsiveness of the Visual Perceptual and Fine Motor Function Tests in School-Aged Children With Mild Intellectual Disabilities. Occup Ther Int. 2026;2026(1):e5560931. doi: 10.1155/oti/5560931.
- Measuring global physical health in children with cerebral palsy: illustration of a multidimensional bi-factor model and computerized adaptive testing.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Intellectual Disability
Active, not recruiting
Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome
Rett Syndrome
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Technology-supported Motor Rehabilitation for People With Rett Syndrome
Rett Syndrome
Not yet recruiting
Single Session Support for Parents of Children With Neurodevelopmental Disabilities Struggling With Anxious Avoidance
Neurodevelopmental Disorders, Autism Spectrum Disorder (ASD)
Enrolling by invitationPhase 2/3
An Extension Study of the Long-Term Safety, Tolerability, and Efficacy of Tividenofusp Alfa (DNL310) in Participants With Mucopolysaccharidosis Type II (MPS II) From Study DNLI-E-0002 or Study DNLI-E-0007
Mucopolysaccharidosis II
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yee-Pay Wuang, PhD principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intellectual Disability, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOT-2 (time frame: Baseline (pretest)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05451238, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.