NCT04235465

Brief Summary

The aim of the present study is to investigate reliability in dyslexic children and compare it with healthy peers.

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 Apr 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

2 months

First QC Date

January 16, 2020

Last Update Submit

January 21, 2023

Conditions

Keywords

Dynamic Gait IndexReliabilityBalanceGait

Outcome Measures

Primary Outcomes (2)

  • The Dynamic Gait Index

    The Dynamic Gait Index measures functionality and dynamic balance in walking and stair climbing. The DGI consists of 8 items including normal gait on flat ground, gait with speed changes, gait with horizontal head movements, gait with vertical head movements, gait and pivot turn, gait and step over obstacle, gait around obstacles and steps up and down stairs. The performance on each item is rated on a 4-point scale ranging from 0 (severe disorder) to 3 (independent walking). The total score is 24.

    Day 0

  • The Dynamic Gait Index

    The Dynamic Gait Index measures functionality and dynamic balance in walking and stair climbing. The DGI consists of 8 items including normal gait on flat ground, gait with speed changes, gait with horizontal head movements, gait with vertical head movements, gait and pivot turn, gait and step over obstacle, gait around obstacles and steps up and down stairs. The performance on each item is rated on a 4-point scale ranging from 0 (severe disorder) to 3 (independent walking). The total score is 24.

    Day 3

Secondary Outcomes (2)

  • The Timed Up and Go Test

    Day 0

  • Functional Reach Test

    Day 0

Study Arms (2)

Dyslexia Group

30 patients will be included. Dynamic Gait Index and other assessments will be performed twice with a 7-day interval by two evaluators

Other: Dynamic Gait Index

Healthy Control Group

30 healthy children will be included. Dynamic Gait Index will be performed.

Other: Dynamic Gait Index

Interventions

The Dynamic Gait Index (DGI) measures functionality and dynamic balance in walking and stair climbing. The DGI consists of 8 items including normal gait on flat ground, gait with speed changes, gait with horizontal head movements, gait with vertical head movements, gait and pivot turn, gait and step over an obstacle, gait around obstacles and steps up and downstairs. The performance on each item is rated on a 4-point scale ranging from 0 (severe disorder) to 3 (independent walking). The total score is 24.

Dyslexia GroupHealthy Control Group

Eligibility Criteria

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

30 dyslexia patients, between 8 - 14 years of age, and 30 healthy volunteer peers

You may qualify if:

  • Confirmed diagnosis of dyslexia by Child and Adolescent Psychiatry
  • Intelligence quotient (IQ)\> 85 results of WISC-R
  • Age between 8 - 14
  • Able to understand the commands given
  • Volunteer to study

You may not qualify if:

  • Having cognitive disorder
  • Having neuromuscular disorder
  • Having skeletal anomaly
  • Having visual or hearing problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Istanbul, 34890, Turkey (Türkiye)

Location

Related Publications (5)

  • Barela JA, Dias JL, Godoi D, Viana AR, de Freitas PB. Postural control and automaticity in dyslexic children: the relationship between visual information and body sway. Res Dev Disabil. 2011 Sep-Oct;32(5):1814-21. doi: 10.1016/j.ridd.2011.03.011. Epub 2011 Apr 16.

  • Cattaneo D, Jonsdottir J, Repetti S. Reliability of four scales on balance disorders in persons with multiple sclerosis. Disabil Rehabil. 2007 Dec 30;29(24):1920-5. doi: 10.1080/09638280701191859. Epub 2007 Apr 26.

  • de Freitas PB, Pedao ST, Barela JA. Visuomotor processing and hand force coordination in dyslexic children during a visually guided manipulation task. Res Dev Disabil. 2014 Oct;35(10):2352-8. doi: 10.1016/j.ridd.2014.06.002. Epub 2014 Jun 22.

  • Gouleme N, Gerard CL, Bucci MP. The Effect of Training on Postural Control in Dyslexic Children. PLoS One. 2015 Jul 10;10(7):e0130196. doi: 10.1371/journal.pone.0130196. eCollection 2015.

  • Kapoula Z, Bucci MP. Postural control in dyslexic and non-dyslexic children. J Neurol. 2007 Sep;254(9):1174-83. doi: 10.1007/s00415-006-0460-0. Epub 2007 Aug 3.

MeSH Terms

Conditions

DyslexiaGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Naime Evrim Karadag-Saygi, Prof

    Department of PM&R, Marmara University School of Medicine

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 16, 2020

First Posted

January 22, 2020

Study Start

April 2, 2018

Primary Completion

June 1, 2018

Study Completion

July 31, 2018

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations