Intellectual DisabilityNCT05473377
Computerized Testing System for Measuring Motor and Sensory Integrative Functions in Intellectual Disabilities
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 Jan 2024to 31 Dec 2024
- How long will I take part?
- 1 Year
- 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: 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).
Who may be able to join
- 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.
Who cannot join
- -Severe emotional disturbances.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Dept of Occupational Therapy
Kaohsiung City, 807
Yee-Pay Wuang, PhD, 07-3121101 ext. 2650, yeepwu@kmu.edu.tw
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). 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.
Read the 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.
- 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.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: posttest: 6 months after the pretest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start1 Jan 2024 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
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
- NCT05473377
- Sponsor's protocol ID
- KMUHIRB-SV(I)-20210116
- Status last verified
- Dec 2023
- First submitted
- 5 Jul 2022
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 16935059
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. 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
- NCT05473377
- Acronym / sponsor ID
- KMUHIRB-SV(I)-20210116
- Conditions
- Intellectual Disability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 25 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). 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Age groups
- Child
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -Severe emotional disturbances.
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
Bruininks-Oseretsky Test of Motor Proficiency- Second Edition
Time frame: pretest: within the first month of the study
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
Bruininks-Oseretsky Test of Motor Proficiency- Second Edition
Time frame: posttest：6 months after the pretest
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
Sensory Profile
Time frame: pretest: within the first month of the study
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.
Sensory Profile
Time frame: posttest: 6 months after the pretest
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.
Test of Visual Perceptual Skills, Third Edition
Time frame: pretest: within the first month of the study
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.
Test of Visual Perceptual Skills, Third Edition
Time frame: posttest：6 months after the pretest
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.
Cognitive/Behavioral Tasks Performance Scale (CBTPS) of School Function Assessment
Time frame: pretest: within the first month of the study
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.
Cognitive/Behavioral Tasks Performance Scale (CBTPS) of School Function Assessment
Time frame: posttest: 6 months after the pretest
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.
Physical Task Performance Scale (PTPS) of School Function Assessment
Time frame: pretest: within the first month of the study
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.
Physical Task Performance Scale (PTPS) of School Function Assessment
Time frame: posttest: 6 months after the pretest
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Results publication: PubMed 16935059Haley 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.
- Measurement precision and efficiency of multidimensional computer adaptive testing of physical functioning using the pediatric evaluation of disability inventory.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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 4 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 29 Dec 2023. 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?
Contact Yee-Pay Wuang, PhD (07-3121101 ext. 2650, yeepwu@kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bruininks-Oseretsky Test of Motor Proficiency- Second Edition (time frame: pretest: within the first month of the study). The study lists 10 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 NCT05473377, which also lists 1 linked publication.
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 29 Dec 2023.