NCT04386161

Brief Summary

Dyslexia is described as a learning disability with a neurological origin. It is a widespread disease, characterized by difficulties in recognition of words, spelling, and decoding. Postural balance is the ability to control the center of gravity (CoG) on the support base. This control starts to appear at the beginning of the 15th months of life and reaches its maximum capacity at around 12 years with the maturation of visual, vestibular, and somatosensory systems. Static balance defines the postural control state in the maintaining position, while dynamic balance represents it during movement. Static and dynamic balance has been widely investigated and found to be impaired in different pediatric disorders such as cystic fibrosis, cerebral palsy, and spina bifida. There is also apparent evidence of deteriorated balance in children with dyslexia. Although quite a number of studies investigated balance impairment in individuals with dyslexia, only one study was interested in the effects of a postural training program and found significant improvements. That study addressed such improvements to brain plasticity, however, did not investigate the reading performance simultaneously. The aim of this study was to demonstrate the changes in static and dynamic balance, reading performance, and quality of life after a six week after a scheduled exercise program in children with dyslexia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

May 5, 2020

Last Update Submit

May 16, 2020

Conditions

Keywords

DyslexiaBalanceExercise Program

Outcome Measures

Primary Outcomes (2)

  • Static Balance Assessment

    Postural sway velocities on the firm and foam surfaces with eyes opened and closed conditions of Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test

    Day 0

  • Static Balance Assessment

    Postural sway velocities on the firm and foam surfaces with eyes opened and closed conditions of Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) test

    Week 6

Secondary Outcomes (14)

  • Dynamic Balance Assessment, Reaction time

    Day 0

  • Dynamic Balance Assessment, Reaction time

    Week 6

  • Dynamic Balance Assessment, Movement time

    Day 0

  • Dynamic Balance Assessment, Movement time

    Week 6

  • Dynamic Balance Assessment, Endpoint excursion

    Day 0

  • +9 more secondary outcomes

Study Arms (1)

Children with dyslexia

EXPERIMENTAL

Children, aged between 8 and 11 years, with clinical dyslexia diagnosed by a child and adolescent psychiatrist

Other: Scheduled exercise program

Interventions

45 minutes of stretching, strengthening, and balance-coordination exercises and 20 minutes of balance training on the Balance Master® device twice a week for six weeks

Children with dyslexia

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed with dyslexia by a child and adolescent psychiatrist
  • WISC R test result in IQ\> 85

You may not qualify if:

  • Having hyperactivity disorder according to DSM-5
  • Having a neuromuscular disease, skeletal anomaly, or vision and hearing problem
  • Using an antipsychotic drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kardelen Gencer Atalay

Istanbul, 34899, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dyslexia

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Evrim Karadag Saygi

    Marmara University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Children, aged between 8 and 11 years, with clinical dyslexia diagnosed by a child and adolescent psychiatrist
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2020

First Posted

May 13, 2020

Study Start

January 1, 2018

Primary Completion

June 1, 2018

Study Completion

December 1, 2018

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations