- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07358143
Gross Motor Skills Predict Adaptive Behavior in Institutionalized Children With Severe Intellectual Disability: A Cross-Sectional Study (TGMD-ADQ)
Associations Between Motor Ability and Adaptive Behavior and Their Predictive Value in Children With Severe Intellectual Disability
This study examines whether gross motor skills are linked to everyday functioning (adaptive behavior) in children with severe intellectual disability (ID) living in social welfare institutions. We recruited 227 orphaned children aged 6-12 years from six welfare institutions in China.
Gross motor competence was assessed using the Test of Gross Motor Development-Second Edition (TGMD-2), which includes locomotor skills and object control skills. :contentReference[oaicite:1]{index=1} Adaptive behavior was assessed using the Adaptive Behavior Questionnaire for Children (ADQ), which provides an overall ADQ Index and scores for independence, cognition, and socialization.
Assessments were conducted on site by a trained research team between May and June 2024. TGMD-2 sessions were video recorded and scored by trained raters, and caregivers completed the ADQ with assistance to ensure completeness. :contentReference[oaicite:3]{index=3} We will evaluate associations between TGMD-2 scores and ADQ outcomes and assess whether the TGMD-2 total score can help screen for children at risk of low adaptive functioning (ADQ Index < 70).
All procedures were approved by the local university ethics committee (approval number: 102772024RT062), and informed consent was obtained from institutional administrators and caregivers.
Study Overview
Status
Conditions
Detailed Description
Background:
Children with severe intellectual disability (ID) living in institutional settings often experience substantial limitations in both motor competence and adaptive functioning. Efficient ways to identify children at higher functional risk may help guide prioritization of supportive services within resource-limited institutions.
Study Design:
This is an observational, cross-sectional study conducted in six social welfare institutions (orphanages) in China using a convenience sampling approach. A total of 227 orphaned children aged 6-12 years with severe ID were recruited. Severe ID was defined based on DSM-5 clinical diagnosis with standardized intelligence test scores ranging from 20 to 34. Additional inclusion criteria included basic auditory and visual abilities and the capacity to follow simple motor instructions. Exclusion criteria included severe musculoskeletal disorders, neurological comorbidities (e.g., active epilepsy), other physical conditions limiting motor assessment participation, or major surgery within the previous six months.
Procedures and Assessments:
All assessments were conducted on site by a professionally trained research team between May and June 2024. :contentReference[oaicite:9]{index=9} Gross motor competence was measured using the Test of Gross Motor Development-Second Edition (TGMD-2), which includes locomotor and object control subtests. Testing followed a standardized instruction-demonstration-imitation protocol. TGMD-2 sessions were video recorded; two trained raters independently scored performance, and a third rater adjudicated disagreements to enhance scoring accuracy.
Adaptive behavior was assessed using the Adaptive Behavior Questionnaire for Children (ADQ), which includes three domains (independence, cognition, and socialization) and yields an overall Adaptive Deviation Quotient (ADQ Index) based on standardized scoring procedures. An ADQ Index < 70 was used to classify low adaptive behavior. The ADQ was completed with face-to-face assistance provided to caregivers to ensure data completeness and reliability.
Analysis Plan:
Descriptive statistics will summarize participant characteristics. Pearson correlations will examine associations between TGMD-2 scores (total and subtests) and ADQ outcomes. Multiple linear regression models will evaluate the unique contribution of TGMD-2 scores to overall adaptive functioning and ADQ domains while adjusting for age and sex. Receiver operating characteristic (ROC) analysis will be used to evaluate the ability of TGMD-2 total score to identify low adaptive behavior (ADQ Index < 70) and to estimate an optimal screening threshold using standard ROC indices.
Ethics:
All procedures were conducted in accordance with the Declaration of Helsinki and approved by the local university ethics committee (approval number: 102772024RT062). Written informed consent was obtained from institutional administrators and caregivers.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ph.d
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Shanghai, Ph.d, China, 200438
- Shanghai University of Sport, School of Physical Education and Training
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:1.Clinical diagnosis of severe intellectual disability according to DSM-5, with standardized intelligence test scores ranging from 20 to 34.2.Age between 6 and 12 years.3.Basic auditory and visual abilities and the capacity to understand and follow simple motor instructions.4.Orphaned children residing in social welfare institutions (orphanages) for extended periods.5.Written informed consent obtained from institutional administrators and caregivers.
Exclusion Criteria:1.Severe musculoskeletal disorders, neurological comorbidities (e.g., active epilepsy), or other physical conditions that could restrict participation in gross motor assessments.2.History of major surgery within the previous six months.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Severe ID Cohort (Institutionalized Children)
A convenience sample of 227 orphaned children with severe intellectual disability recruited from six social welfare institutions (orphanages) in China.
All participants resided in institutional care for extended periods and completed one-time assessments, including TGMD-2 motor testing and caregiver-assisted ADQ adaptive behavior evaluation.
Data were collected between May and June 2024.
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Standardized gross motor skill assessment (locomotor and object control subtests) administered at a single time point.
Testing followed an instruction-demonstration-imitation protocol; sessions were video recorded and independently scored by two trained raters with adjudication by a third rater if needed.
This is an assessment procedure, not a therapeutic intervention.
Caregiver-assisted administration of the Adaptive Behavior Questionnaire for Children (ADQ) to obtain the overall ADQ Index and domain scores (independence, cognition, socialization).
Standardized scoring was used; ADQ Index < 70 was used to classify low adaptive behavior for analysis.
This is an assessment procedure, not a therapeutic intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Adaptive behavior (ADQ Index)
Time Frame: At assessment (single time point; May-June 2024).
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Overall adaptive functioning measured by the Adaptive Behavior Questionnaire for Children (ADQ).
The ADQ Index is derived from standardized scoring procedures; higher scores indicate better adaptive behavior.
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At assessment (single time point; May-June 2024).
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102772024RT062
- SUS (Other Identifier: Shanghai University of Sport)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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