NCT07533409

Brief Summary

The aim of this study was to compare fingertip tactile sensation, hand and finger grip strength, and hand pain thresholds in children diagnosed with specific learning disorder with impairment in written expression and healthy controls.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
5mo left

Started Apr 2026

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

Study Progress5%
Apr 2026Sep 2026

First Submitted

Initial submission to the registry

April 9, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2026

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Outcome Measures

Primary Outcomes (4)

  • Fingertip light touch

    The participants' light touch sensory thresholds will be assessed using Semmes-Weinstein monofilaments, which consist of calibrated synthetic monofilaments that differ in thickness and the amount of pressure applied. Measurements will be taken from the midpoint of the distal phalanx on the palmar surface of the first, second, and third fingers of the right hand. The test will be performed with the participants' eyes closed; starting with the smallest monofilament, contact will be applied to the test area and progressively larger monofilaments will be used. The test will be terminated when the participant first perceives the touch, and the corresponding value will be recorded.

    Baseline

  • Hand grip strength

    Hand grip strength will be assessed using a Jamar dynamometer (Patterson Medical, Green Bay, WI, USA). During the assessment, the participant will be seated with the shoulders adducted and in neutral rotation, the elbow flexed at 90°, the forearm in a neutral position, and the wrist between 0° and 30° of dorsiflexion. The evaluator will gently support the base of the dynamometer, place it in the participant's hand, and instruct the participant to squeeze as hard as possible. Three measurements of maximum voluntary contraction will be obtained for the right hand, and the highest value will be recorded in kilograms.

    Baseline

  • Finger pinch strength

    The pinch strength between the thumb and index finger of the participants' right hand will be assessed using a Jamar pinch gauge. During the assessment, the shoulder will be in adduction and neutral rotation, the elbow flexed at 90°, the forearm in mid-rotation, and the wrist in a neutral position. The participant will be instructed to squeeze the pinch gauge between the thumb and index finger as hard as possible. Three measurements of maximum voluntary contraction will be obtained for the right hand, and the highest value will be recorded in kilograms.

    Baseline

  • Pressure pain threshold

    The pressure pain threshold will be used to assess the patients' pain perception threshold. Pressure pain threshold will be measured using a manual pressure algometer (Baseline Dolorimeter®). The patients' pain perception thresholds will be measured at the right lateral epicondyle and at the midpoint of the web space between the first and second fingers. During the measurement, the algometer's flat circular probe with a surface area of 1.52 cm² will be placed on the relevant site, and pressure will be increased at a rate of 1 kg/second. The patients will be instructed to indicate the onset of pain by saying "stop" or by raising their hand when they begin to feel slight discomfort. For each reference site, the value will be calculated as the arithmetic mean of two measurements taken 30 seconds apart.

    Baseline

Study Arms (2)

Specific learning disorder with impairment in written expression

The children diagnosed with specific learning disorder with impairment in written expression according to the DSM-5 diagnostic criteria

Other: Treatment outcome

Control

The healthy children with no known medical condition

Other: Treatment outcome

Interventions

The participants' fingertip light touch and pain sensory thresholds, as well as hand and fingertip pinch strength, will be evaluated.

ControlSpecific learning disorder with impairment in written expression

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study will include 33 children diagnosed with specific learning disorder with impairment in written expression and 33 healty control children.

You may qualify if:

  • Diagnosis of specific learning disorder with impairment in written expression according to the DSM-5 diagnostic criteria
  • Age between 6 and 12 years
  • Clinically normal intellectual functioning
  • Voluntary agreement to participate in the study
  • Absence of any systemic disease
  • Right-hand dominance
  • Age between 6 and 12 years
  • Clinically normal intellectual functioning
  • Willingness to participate in the study on a voluntary basis
  • Absence of any systemic disease
  • Right-hand dominance

You may not qualify if:

  • Presence of verbal or visual communication problems
  • History of perinatal complications or physical head trauma
  • Presence of psychiatric disorders other than specific learning disorder according to the DSM-5 diagnostic criteria
  • History of known chronic physical or neurological disease (such as cerebral palsy, diabetes, epilepsy, autoimmune disease, liver failure, or kidney failure)
  • Presence of substance or alcohol use disorder
  • Diagnosis of a genetic disorder
  • Previous surgery involving the hand region
  • Presence of infection and/or sensory deficit in the hand region
  • Presence of any psychiatric disorder according to the DSM-5 diagnostic criteria
  • Presence of verbal or visual communication problems
  • History of perinatal complications or physical head trauma
  • History of known chronic physical or neurological disease (such as cerebral palsy, diabetes, epilepsy, autoimmune disease, liver failure, or kidney failure)
  • Presence of substance or alcohol use disorder
  • Diagnosis of a genetic disorder
  • Previous surgery involving the hand region
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan 1. Murat State Hospital

Edirne, 22030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Somatosensory DisordersPainSpecific Learning Disorder

Interventions

Treatment Outcome

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLearning DisabilitiesCommunication DisordersNeurobehavioral ManifestationsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PrognosisDiagnosisOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Study Officials

  • İbrahim Tiryaki, MD

    Sultan 1. Murat State Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 16, 2026

Study Start

April 10, 2026

Primary Completion (Estimated)

August 10, 2026

Study Completion (Estimated)

September 10, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations