NCT05451238

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 6, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 11, 2022

Status Verified

July 1, 2022

Enrollment Period

2.4 years

First QC Date

July 6, 2022

Last Update Submit

July 8, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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

    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

    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''.

    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)

    Baseline (pretest)

Eligibility Criteria

Age6 Years - 15 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

school-aged children with different level of intellectual disabilities

You may qualify if:

  • 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).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Occupational Therapy

Kaohsiung City, 807, Taiwan

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Yee-Pay Wuang, PhD

    Kaohsiung Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2022

First Posted

July 11, 2022

Study Start

August 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

July 11, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations