NCT05902143

Brief Summary

Specific Learning Disorder (SLD) is a neurodevelopmental disorder in which a person shows difficulties in reading, written narration, and/or mathematics. 30 to 50 percent of children with SLD experience difficulties in fine motor skills, such as handwriting skills, and also during self-care activities and activities that require sorting. This study will evaluate children with SLD and healthy ages within fine motor skills, handgrip strength, and hand-forearm anthropometric measurements. Our study will show the impact of the fine motor skills of children with SLD on their quality of life and participation in daily life activities. In light of our current knowledge, no study has been found that comprehensively examines the fine motor functions of children with SLD. Therefore, normative data on the upper extremity functions of children with SLD will be presented to the literature. In this context, our work will shed light on the development of new treatments and assessment methods for clinicians and researchers working with children with SLD.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

June 30, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2024

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

7 months

First QC Date

June 5, 2023

Last Update Submit

June 5, 2023

Conditions

Keywords

Specific Learning DisorderFine motor skillsGrip strengthUpper extremityChildren

Outcome Measures

Primary Outcomes (4)

  • Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2)

    Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2) is norm referenced and designed to measure gross and fine motor skills in youth 4 to 21 years of age. Standard scores 40 are considered below average, whereas those \>40 range from average to above average.

    Baseline

  • Purdue Pegboard Test

    The Purdue Pegboard Test consists of a board with four subtests: Dominant hand, Non-Dominant hand, Bimanual and Assembly. Each subtest was administered three times in a row. The dominant hand and non-dominant hand subtests required to place as many pegs as possible in the column corresponding to the hand being tested within 30-sec. The dominant hand is tested first followed by the non-dominant hand. In the bimanual subtest, both hands simultaneously placed a pair of pegs in both columns. The scores on these three tests were the pairs of pegs for the bimanual subtest, placed within 30-sec. The assembly subtest required picking up and placing pegs, washers, collars and second washers using alternating hands. This score represents the number of pieces assembled within 60-sec.

    Baseline

  • Hand Dynamometer

    Hand Dynamometer will be used to evaluate hand grip strength. Measurements will be performed in the position defined by the American Association of Hand Therapists. During the test, the child will be seated with a 90° flexion angle of the hip and knee. Three measurements will be made to measure the hand grip strength.

    Baseline

  • Pinch Gauge

    "Pinch Gauge" will be used to evaluate finger strength. Measurements will be performed in the position defined by the American Association of Hand Therapists. Finger strengths will be recorded by asking the children to grasp at maximal strength in the three basic types of fine grip. These are fingertip grip, lateral grip, and three-point grip positions, respectively.

    Baseline

Secondary Outcomes (2)

  • Participation and Environment Measurement Child & Youth (PEM-CY)

    Baseline

  • The Pediatric Quality of Life Inventory (PEDS-QL)

    Baseline

Study Arms (2)

Experimental Group

children with Specific Learning Disorder

Control Group

children with typically developing children

Eligibility Criteria

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

children with specific learning disorder and typically developing peers

You may qualify if:

  • years old
  • Patients diagnosed with SLD by a physician, regardless of subtype.
  • Cognitive ability to follow instructions for assessment measures
  • Families and children who agreed to participate in the study

You may not qualify if:

  • Any psychiatric diagnosis such as autism spectrum disorder, psychotic symptoms, depression
  • Children with a neurological or orthopedic disorder such as head trauma, Cerebral Palsy, epileptic seizures and speech disorder
  • Families and children who do not agree to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

Related Publications (10)

  • Silver CH, Ruff RM, Iverson GL, Barth JT, Broshek DK, Bush SS, Koffler SP, Reynolds CR; NAN Policy and Planning Committee. Learning disabilities: the need for neuropsychological evaluation. Arch Clin Neuropsychol. 2008 Mar;23(2):217-9. doi: 10.1016/j.acn.2007.09.006. Epub 2007 Oct 30.

    PMID: 17977692BACKGROUND
  • Rutter M, Caspi A, Fergusson D, Horwood LJ, Goodman R, Maughan B, Moffitt TE, Meltzer H, Carroll J. Sex differences in developmental reading disability: new findings from 4 epidemiological studies. JAMA. 2004 Apr 28;291(16):2007-12. doi: 10.1001/jama.291.16.2007.

    PMID: 15113820BACKGROUND
  • Darki F, Peyrard-Janvid M, Matsson H, Kere J, Klingberg T. Three dyslexia susceptibility genes, DYX1C1, DCDC2, and KIAA0319, affect temporo-parietal white matter structure. Biol Psychiatry. 2012 Oct 15;72(8):671-6. doi: 10.1016/j.biopsych.2012.05.008. Epub 2012 Jun 9.

    PMID: 22683091BACKGROUND
  • Raschle NM, Chang M, Gaab N. Structural brain alterations associated with dyslexia predate reading onset. Neuroimage. 2011 Aug 1;57(3):742-9. doi: 10.1016/j.neuroimage.2010.09.055. Epub 2010 Sep 25.

    PMID: 20884362BACKGROUND
  • Goldstand S, Gevir D, Yefet R, Maeir A. Here's How I Write-Hebrew: Psychometric Properties and Handwriting Self-Awareness Among Schoolchildren With and Without Dysgraphia. Am J Occup Ther. 2018 Sep/Oct;72(5):7205205060p1-7205205060p9. doi: 10.5014/ajot.2018.024869.

    PMID: 30157018BACKGROUND
  • Di Brina C, Averna R, Rampoldi P, Rossetti S, Penge R. Reading and Writing Skills in Children With Specific Learning Disabilities With and Without Developmental Coordination Disorder. Motor Control. 2018 Oct 1;22(4):391-405. doi: 10.1123/mc.2016-0006. Epub 2018 Feb 28.

    PMID: 29488824BACKGROUND
  • McHale K, Cermak SA. Fine motor activities in elementary school: preliminary findings and provisional implications for children with fine motor problems. Am J Occup Ther. 1992 Oct;46(10):898-903. doi: 10.5014/ajot.46.10.898.

    PMID: 1463061BACKGROUND
  • Moe-Nilssen R, Helbostad JL, Talcott JB, Toennessen FE. Balance and gait in children with dyslexia. Exp Brain Res. 2003 May;150(2):237-44. doi: 10.1007/s00221-003-1450-4. Epub 2003 Apr 8.

    PMID: 12682807BACKGROUND
  • Cowley JC, Gates DH. Inter-joint coordination changes during and after muscle fatigue. Hum Mov Sci. 2017 Dec;56(Pt B):109-118. doi: 10.1016/j.humov.2017.10.015. Epub 2017 Nov 6.

    PMID: 29121490BACKGROUND
  • Anakwe RE, Huntley JS, McEachan JE. Grip strength and forearm circumference in a healthy population. J Hand Surg Eur Vol. 2007 Apr;32(2):203-9. doi: 10.1016/J.JHSB.2006.11.003. Epub 2007 Jan 2.

    PMID: 17197064BACKGROUND

MeSH Terms

Conditions

Specific Learning Disorder

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ishak Isık, Prof. Dr.

CONTACT

Ozgun Kaya Kara, Assoc. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. PhD

Study Record Dates

First Submitted

June 5, 2023

First Posted

June 13, 2023

Study Start

June 30, 2023

Primary Completion

January 30, 2024

Study Completion

February 12, 2024

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations