NCT06934850

Brief Summary

This comparative, cross-sectional observational study examined handgrip strength, trunk muscle endurance, and functional mobility in adolescents aged 12-18 years with mild intellectual disability and compared their performance with typically developing peers. A total of 51 participants were evaluated during a single assessment session, including 24 adolescents with mild intellectual disability and 27 typically developing adolescents. Handgrip strength was measured using a digital hand dynamometer, trunk muscle endurance was assessed using the McGill trunk endurance test battery, and functional mobility was evaluated using the Timed Up and Go Test and the Timed Up and Down Stairs Test. The study also examined the relationships among handgrip strength, trunk muscle endurance, and functional mobility.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

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

First Submitted

Initial submission to the registry

March 14, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2025

Completed
Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

1 month

First QC Date

March 14, 2025

Last Update Submit

July 31, 2026

Conditions

Keywords

Mild Intellectual DisabilityHandgrip StrengthTrunk Muscle EnduranceFunctional MobilityMcGill Trunk Endurance TestTimed Up and Go TestTimed Up and Down Stairs TestAdolescents

Outcome Measures

Primary Outcomes (3)

  • Mean Hand Grip Strength in kilograms (kg)

    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.

    At the single study assessment visit (Day 0)

  • Trunk Muscle Endurance Assessed With the McGill Test Battery

    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.

    At the single study assessment visit (Day 0)

  • Functional Mobility Assessed With the Timed Up and Go Test

    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 Outcomes (1)

  • Functional Stair Mobility Assessed With the Timed Up and Down Stairs Test (TUDS)

    At the single study assessment visit (Day 0)

Study Arms (2)

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.

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.

Interventions

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consisted of adolescents aged 12-18 years recruited using a non-probability convenience sampling method. The mild intellectual disability group included adolescents with a clinical diagnosis of mild intellectual disability according to DSM-5 criteria. The comparison group included typically developing adolescents without intellectual disability or a neurological, neurodevelopmental, orthopedic, or serious systemic condition that could affect assessment performance. All participants included in the final analysis completed the assessments during a single study visit.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malatya Training and Research Hospital

Malatya, Malatya, 44280, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BURAK,BUĞDAY , PT, MSc, Lecturer in Physiotherapy and Rehabilitation, Principal Investigator

Study Record Dates

First Submitted

March 14, 2025

First Posted

April 18, 2025

Study Start

April 15, 2025

Primary Completion

May 19, 2025

Study Completion

June 4, 2025

Last Updated

August 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data are not planned to be shared publicly because the dataset contains sensitive information from adolescent participants, including individuals with intellectual disability.

Locations