Intellectual DisabilityNCT06934850
Handgrip Strength, Trunk Muscle Endurance, and Functional Mobility in Adolescents With Mild Intellectual Disability
An observational study of Intellectual Disability, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2025to 4 Jun 2025
- 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 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Malatya Training and Research Hospital
Malatya, Malatya, 44280
About this study
Official title: Relationship Between Handgrip Strength, Trunk Muscle Endurance, and Functional Mobility in Adolescents With Mild Intellectual Disability: A Cross-Sectional Comparison With Typically Developing Peers
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.
Read the 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.
- Conditions
- Intellectual Disability
- Keywords
- Mild Intellectual Disability, Handgrip Strength, Trunk Muscle Endurance, Functional Mobility, McGill Trunk Endurance Test, Timed Up and Go Test, Timed Up and Down Stairs Test, Adolescents
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At the single study assessment visit (Day 0)
Secondary outcomes (1)
Functional Stair Mobility Assessed With the Timed Up and Down Stairs Test (TUDS)
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.
Measured: At the single study assessment visit (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start15 Apr 2025
- Primary completion19 May 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Buğday, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934850
- Sponsor's protocol ID
- 2025/6862
- Status last verified
- Jul 2026
- First submitted
- 14 Mar 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared publicly because the dataset contains sensitive information from adolescent participants, including individuals with intellectual disability.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Handgrip Strength, Trunk Muscle Endurance, and Functional Mobility in Adolescents With Mild Intellectual Disability: A Cross-Sectional Comparison With Typically Developing Peers
- ClinicalTrials.gov ID
- NCT06934850
- Acronym / sponsor ID
- 2025/6862
- Conditions
- Intellectual Disability
- Keywords
- Mild Intellectual Disability, Handgrip Strength, Trunk Muscle Endurance, Functional Mobility, McGill Trunk Endurance Test, Timed Up and Go Test, Timed Up and Down Stairs Test, Adolescents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 18 Apr 2025 (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 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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
1 secondary outcome
Functional Stair Mobility Assessed With the Timed Up and Down Stairs Test (TUDS)
Time frame: At the single study assessment visit (Day 0)
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 4 Aug 2026.
- Hand grip strength as a proposed new vital sign of health: a narrative review of evidencesLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared publicly because the dataset contains sensitive information from adolescent participants, including individuals with intellectual disability.
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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 Intellectual Disability, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. 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 4 Aug 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 Turkey (Türkiye). 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?
Mean Hand Grip Strength in kilograms (kg) (time frame: At the single study assessment visit (Day 0)). The study lists 3 primary outcomes in all. 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 4 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.