Severe Intellectual DisabilityTGMD-ADQNCT07358143
Gross Motor Skills Predict Adaptive Behavior in Institutionalized Children With Severe Intellectual Disability: A Cross-Sectional Study
An observational study of Severe Intellectual Disability, run by Xili Wen at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Severe Intellectual Disability
- What is being tested?
- Test of Gross Motor Development-Second Edition (TGMD-2) Assessment and Adaptive Behavior Questionnaire for Children (ADQ) Assessment
- How many people
- 227 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2024to 3 Jun 2024
- 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 12 years
- All sexes
- No healthy volunteers
- Child
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.
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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai University of Sport, School of Physical Education and Training
Shanghai, Ph.d, 200438
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Severe Intellectual Disability
- Being tested
- Test of Gross Motor Development-Second Edition (TGMD-2) Assessment, Adaptive Behavior Questionnaire for Children (ADQ) Assessment
- Keywords
- Intellectual Disability, Adaptive Behavior, Gross Motor Skills, Motor Competence
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test of Gross Motor Development-Second Edition (TGMD-2) AssessmentDiagnostic test
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.
Adaptive Behavior Questionnaire for Children (ADQ) AssessmentDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Test of Gross Motor Development-Second Edition (TGMD-2) Assessment; Diagnostic Test: Adaptive Behavior Questionnaire for Children (ADQ) Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At assessment (single time point; May-June 2024).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start3 May 2024
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe 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
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xili Wen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xili Wen, Shanghai University of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358143
- Sponsor's protocol ID
- 102772024RT062
- Other IDs
- SUS
- Acronym
- TGMD-ADQ
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between Motor Ability and Adaptive Behavior and Their Predictive Value in Children With Severe Intellectual Disability
- ClinicalTrials.gov ID
- NCT07358143
- Acronym / sponsor ID
- TGMD-ADQ / 102772024RT062
- Conditions
- Severe Intellectual Disability
- Keywords
- Intellectual Disability, Adaptive Behavior, Gross Motor Skills, Motor Competence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Xili WenUniversity, hospital or other
- Study start
- 3 May 2024 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 22 Jan 2026 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe ID Cohort (Institutionalized Children) | – | Diagnostic Test: Test of Gross Motor Development-Second Edition (TGMD-2) Assessment, Diagnostic Test: Adaptive Behavior Questionnaire for Children (ADQ) AssessmentA 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test of Gross Motor Development-Second Edition (TGMD-2) AssessmentStandardized 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. | Diagnostic test | Severe ID Cohort (Institutionalized Children) |
| Adaptive Behavior Questionnaire for Children (ADQ) AssessmentCaregiver-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. | Diagnostic test | Severe ID Cohort (Institutionalized Children) |
Primary outcome
Adaptive behavior (ADQ Index)
Time frame: At assessment (single time point; May-June 2024).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Severe Intellectual Disability, run by Xili Wen at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 22 Jan 2026. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adaptive behavior (ADQ Index) (time frame: At assessment (single time point; May-June 2024).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2026.