NCT07358143

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
227

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

January 14, 2026

Last Update Submit

January 14, 2026

Conditions

Keywords

Intellectual DisabilityAdaptive BehaviorGross Motor SkillsMotor Competence

Outcome Measures

Primary Outcomes (1)

  • Adaptive behavior (ADQ Index)

    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.

    At assessment (single time point; May-June 2024).

Study Arms (1)

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.

Diagnostic Test: Test of Gross Motor Development-Second Edition (TGMD-2) AssessmentDiagnostic Test: Adaptive Behavior Questionnaire for Children (ADQ) Assessment

Interventions

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.

Severe ID Cohort (Institutionalized Children)

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.

Severe ID Cohort (Institutionalized Children)

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

A convenience sample of 227 orphaned children with severe intellectual disability (DSM-5; IQ 20-34), aged 6-12 years, recruited from six social welfare institutions (orphanages) in China. All participants resided in institutional care for extended periods and completed one-time on-site assessments, including TGMD-2 gross motor testing and caregiver-assisted ADQ adaptive behavior evaluation. Data were collected between May and June 2024.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai University of Sport, School of Physical Education and Training

Shanghai, Ph.d, 200438, China

Location

MeSH Terms

Conditions

Intellectual Disability

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.DStudent

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 22, 2026

Study Start

May 3, 2024

Primary Completion

June 3, 2024

Study Completion

June 3, 2024

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations