NCT05319197

Brief Summary

Children with Specific Learning Difficulties (SLD) may have problems with fine and gross motor skills compared to their healthy peers. These children may have poor manual dexterity. Taken together, it is not clear how motor and sensory competence of the hand are affected together. In this study, it was aimed to evaluate the sensory and motor ability of the hand and to compare the examined parameters between the SLD group and the healthy control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

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 31, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

May 5, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

October 15, 2024

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

March 31, 2022

Last Update Submit

October 9, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Bruininks-Oseretsky Motor Proficiency Test- 2 Short Form (BOT-2SF)

    Assesses fine motor precision, fine motor integration, and manual dexterity. Scores are reported as a percentile rank; higher scores indicate better fine motor skills.

    20 minutes

  • Hand Grip Force

    Changes from the baseline, To measure hand grip strength through Hydraulic Hand held Dynamo-meter. It will be measured in kilograms.

    10 minutes

  • Pinch Grip Force

    Participants were seated at a table on which the dynamometers were positioned. The subjects were told to keep their elbow flexed without resting their arm or the grip handle of the dynamometer on the table. Results will be evaluated in pounds.

    6 minutes

  • Abilhand Kids

    to assess for performance of activity. score range 0-42 point, higher scores mean a better outcome.

    5 minutes

  • Minnesota Manual Dexterity Test

    to assess manual dexterity, higher scores mean a worse outcome.

    25 minutes

  • Sensory Function

    Proprioception, stereognosis, and two-point discrimination will be tested. Lower scores indicate better sensory function.

    30 minutes

Study Arms (2)

SLD Group

Other: No Interventions

Healthy Control Group

Other: No Interventions

Interventions

No Interventions

Healthy Control GroupSLD Group

Eligibility Criteria

Age8 Years - 14 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The convenience sampling will implement for this cross-sectional study. Children who have a diagnoisis of special learning disability regarding DSM-V criteria and who attends the Specific Learning Difficulty Support Education Program of the Ministry of National Education regularly twice a week will screen for eligibility by their physician and were subsequently requested to participate in this study.

You may qualify if:

  • To have a diagnosis of special learning disability (regarding DSM-V criteria)
  • To be in the age range of 8-14

You may not qualify if:

  • Any acute or chronic orthopedic or neurological disease that may affect walking performance,
  • Any surgery within the last 6 months,
  • Severe sensory (hearing, vision, etc.) impairment that prevents him/her from taking commands
  • Cognitive and mental severe impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Özel Eğitim ve Rehabilitasyon Merkezi

Afyonkarahisar, 03000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Specific Learning Disorder

Condition Hierarchy (Ancestors)

Learning DisabilitiesCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • İsmail SARAÇOĞLU

    Kutahya Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2022

First Posted

April 8, 2022

Study Start

May 5, 2022

Primary Completion

September 15, 2022

Study Completion

December 15, 2022

Last Updated

October 15, 2024

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations