NCT06934850

Brief Summary

Scope and Limitations of the Project This project aims to examine the relationship between hand grip strength, trunk control, and functional performance in individuals with mild intellectual disability (MID). Individuals with MID face significant challenges in daily life activities and social interactions due to deficiencies in motor skills. Hand grip strength is considered a fundamental indicator of overall muscle strength and level of independence, while trunk control plays a crucial role in both postural stability and dynamic movement coordination. The project seeks to scientifically evaluate the physical and functional parameters of these individuals and highlight the impact of motor control on daily living activities. The study is limited to individuals aged 12-18, including those with intellectual disabilities attending rehabilitation centers and healthy individuals visiting hospitals. While this limitation allows for a focused examination of the needs of a specific group, it may also restrict the generalizability of the findings to the broader population.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Posted

Study publicly available on registry

April 18, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 26, 2025

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2025

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

20 days

First QC Date

March 14, 2025

Last Update Submit

April 12, 2025

Conditions

Keywords

ctional performancetrunk control,and grip strengthild mental retardation individua

Outcome Measures

Primary Outcomes (3)

  • Mean Hand Grip Strength in kilograms (kg)

    Hand grip strength will be measured using a standard Jamar dynamometer in a seated position, with the elbow flexed at 90 degrees. The best of three consecutive trials for each hand will be recorded and averaged. Unit of Measure: kilograms (kg)

    Baseline (Day 0) and Week 8

  • Trunk Control Test Score (0-100 points)

    Trunk control will be evaluated using the Trunk Control Test (TCT), which assesses four functional movements: rolling to the weak side, rolling to the strong side, sitting up from lying down, and maintaining a sitting position. Each task is scored, and total scores range from 0 to 100. Unit of Measure: points (0-100)

    Measured at baseline (Day 0) and at the end of the 8-week intervention period (Week 8)

  • Total Functional Independence Measure (FIM) Score

    Functional performance will be assessed using the Functional Independence Measure (FIM), which evaluates self-care, mobility, communication, and social cognition. Scores range from 18 to 126, with higher scores reflecting greater independence. Unit of Measure: points (18-126)

    Baseline (Day 0) and Week 8

Study Arms (2)

Mild Intellectual Disability (MID) in Children

Mild Intellectual Disability (MID) refers to a neurodevelopmental condition where a child's cognitive abilities and adaptive functioning are below average compared to peers. It typically manifests with an IQ score between 50-70 and difficulties in daily life skills, problem-solving, and academic performance.

Other: Hand grip strength

Normal Development group

A typically developing child follows expected milestones in physical, cognitive, social, and emotional growth according to age. Their development occurs naturally without significant delays or disabilities.

Other: Hand grip strength

Interventions

Collection Tools a) Hand Grip Force Measurement: Hand grip strength will be measured using a digital dynamometer. The measurement will be performed three times in the dominant and nondominant hand of the participant and the average value will be taken (1). b) Trunk Control Assessment: Trunk control will be assessed with the McGill core endurance test. This scale is a valid and reliable tool to objectively measure trunk stability and dynamic control levels (2). c) Motor skill assessment: Timed Up and Go Test: The Timed Up and Go Test was used to assess functional mobility and dynamic balance (3). The patient was told to get up from the chair, walk 3 meters, return and sit back in the chair. The time was recorded. Timed Stair Climbing Test: It consists of the individual climbing the stairs and returning to the starting point. The elapsed time was recorded

Also known as: trunk control, functional performance
Mild Intellectual Disability (MID) in ChildrenNormal Development group

Eligibility Criteria

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

This research is designed to examine the relationship between hand grip strength, trunk control and functional performance in individuals with mild mental retardation. Data collection will be carried out in accordance with ethical rules from rehabilitation and hospitalized individuals.

You may qualify if:

  • Clinical diagnosis of mild mental retardation
  • Individuals aged between 12 and 18 years
  • Sufficient physical ability to perform hand grip strength measurements

You may not qualify if:

  • Impaired trunk control due to an orthopedic or neurological disorder
  • Psychological or physical conditions that prevent active participation in the assessments
  • Mental illnesses or physical disorders in otherwise healthy individuals that may affect measurement outcomes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malatya Training and Research Hospital

Malatya, Malatya, 44280, Turkey (Türkiye)

RECRUITING

Related Links

MeSH Terms

Conditions

Intellectual Disability

Interventions

Hand StrengthPhysical Functional Performance

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Muscle StrengthPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPhysical FitnessHealthPopulation Characteristics

Central Study Contacts

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

May 26, 2025

Primary Completion

June 15, 2025

Study Completion

July 15, 2025

Last Updated

April 18, 2025

Record last verified: 2025-04

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