- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06934850
Handgrip Strength, Trunk Muscle Endurance, and Functional Mobility in Adolescents With Mild Intellectual Disability
Relationship Between Handgrip Strength, Trunk Muscle Endurance, and Functional Mobility in Adolescents With Mild Intellectual Disability: A Cross-Sectional Comparison With Typically Developing Peers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Design
This was a comparative, cross-sectional observational study. Participants were not assigned to any treatment, exercise program, or other intervention. All assessments were completed during a single study visit, and no 8-week intervention or follow-up assessment was conducted.
Participants
The study included 51 adolescents aged 12-18 years. The mild intellectual disability group consisted of 24 adolescents with a clinical diagnosis of mild intellectual disability according to DSM-5 criteria. The comparison group consisted of 27 typically developing adolescents without a diagnosis of intellectual disability, neurodevelopmental disorder, neurological disease, orthopedic condition, or serious systemic disease affecting assessment performance.
Assessments
Handgrip strength was measured separately for the right and left hands using a digital hand dynamometer. Three trials were performed for each hand, and the mean of the three trials was recorded in kilograms.
Trunk muscle endurance was assessed using the McGill trunk endurance test battery, including the trunk flexor endurance test, trunk extensor endurance test, right side bridge test, and left side bridge test. Performance duration was recorded in seconds.
Functional mobility was assessed using the Timed Up and Go Test and the Timed Up and Down Stairs Test. Completion times were recorded in seconds, with shorter times indicating better functional mobility.
Study Objective
The primary objective was to compare handgrip strength, trunk muscle endurance, and functional mobility between adolescents with mild intellectual disability and typically developing peers. The study also examined the relationships among these variables.
Registry Clarification
The initial registry version contained outcome-measure labels and assessment time points that did not correspond to the final assessment battery. After study completion, the record was updated to reflect the actual enrollment, the single-visit assessment schedule, and the outcome measures that were administered. Previous versions of the registry record remain accessible through the record history.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Malatya
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Malatya, Malatya, Turkey (Türkiye), 44280
- Malatya Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
- Adolescents aged 12-18 years.
- For the mild intellectual disability group: a clinical diagnosis of mild intellectual disability according to DSM-5 criteria.
- Ability to understand and follow simple verbal instructions.
- Ability to complete the assessment procedures safely.
- For the typically developing group: no diagnosis of intellectual disability, neurodevelopmental disorder, neurological disease, orthopedic condition, or serious systemic disease that could affect assessment performance.
- Written informed consent obtained from the participant's legal guardian.
- For participants with mild intellectual disability, verbal assent obtained using an age- and cognition-appropriate explanation.
Exclusion Criteria
- An orthopedic or neurological limitation preventing completion of the assessments.
- An additional medical or comorbid condition that could substantially affect assessment performance.
- Inability or unwillingness to complete the assessment session.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Mild Intellectual Disability Group
Adolescents aged 12-18 years with a clinical diagnosis of mild intellectual disability according to DSM-5 criteria, who were able to understand and follow simple verbal instructions and had no orthopedic or neurological limitation preventing completion of the assessments.
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Typically Developing Group
Typically developing adolescents aged 12-18 years without a diagnosis of intellectual disability, neurodevelopmental disorder, neurological disease, orthopedic condition, or serious systemic disease that could affect completion of the assessments.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Hand Grip Strength in kilograms (kg)
Time Frame: At the single study assessment visit (Day 0)
|
Handgrip strength was measured separately for the right and left hands using a digital hand dynamometer.
Three trials were performed for each hand in a standardized seated position, and the mean of the three trials was recorded in kilograms.
Higher values indicated greater handgrip strength.
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At the single study assessment visit (Day 0)
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Trunk Muscle Endurance Assessed With the McGill Test Battery
Time Frame: At the single study assessment visit (Day 0)
|
Trunk muscle endurance was assessed in seconds using the McGill trunk endurance test battery, consisting of the trunk flexor endurance test, trunk extensor endurance test, right side bridge test, and left side bridge test.
The duration for which each standardized test position was maintained was recorded in seconds.
Longer durations indicated greater trunk muscle endurance.
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At the single study assessment visit (Day 0)
|
|
Functional Mobility Assessed With the Timed Up and Go Test
Time Frame: At the single study assessment visit (Day 0)
|
Functional mobility was assessed using the Timed Up and Go Test.
The time required to complete the standardized test was recorded in seconds.
Shorter completion times indicated better functional mobility.
|
At the single study assessment visit (Day 0)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Functional Stair Mobility Assessed With the Timed Up and Down Stairs Test (TUDS)
Time Frame: At the single study assessment visit (Day 0)
|
Functional stair mobility was assessed using the Timed Up and Down Stairs Test (TUDS).
The time required to ascend and descend the stairs according to the standardized test protocol was recorded in seconds.
Shorter completion times indicated better functional stair mobility.
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At the single study assessment visit (Day 0)
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Collaborators and Investigators
Sponsor
Publications and helpful links
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/6862
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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