- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04235465
Dynamic Gait Index in Children With Dyslexia
January 21, 2023 updated by: Marmara University
Reliability of the Dynamic Gait Index in Children With Dyslexia
The aim of the present study is to investigate reliability in dyslexic children and compare it with healthy peers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Assessments methods are very important for the detection and treatment of such problems and there is a need for studies that can be applied for the dyslexia group.
However fewer attempts have been made to demonstrate the reliability of balance impairments tools in dyslexic children.
The DGI is a test that has been used a lot lately because of its minimal requirement for space and equipment, as well as its ability to be used with different patients' groups.
The aim of the present study is to investigate reliability in dyslexic children and compare it with healthy peers.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34890
- Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
30 dyslexia patients, between 8 - 14 years of age, and 30 healthy volunteer peers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Having cognitive disorder
- Having neuromuscular disorder
- Having skeletal anomaly
- Having visual or hearing problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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.
|
Healthy Control Group
30 healthy children will be included.
Dynamic Gait Index will be performed.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Dynamic Gait Index
Time Frame: Day 0
|
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
Time Frame: Day 3
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Timed Up and Go Test
Time Frame: Day 0
|
The Timed Up and Go is a test used to measure mobility and evaluates walking speed, posture control, functional mobility and balance.
|
Day 0
|
Functional Reach Test
Time Frame: Day 0
|
Functional Reach Test (FRT) is a static balance test.
Measurement is carried out by a tape measure attached to the wall parallel to the floor.
The individual was standing parallel to a wall with the feet shoulder wide apart and the shoulders extended at 90 degrees flexion; in this position the third metacarpal head was recorded as the initial position.
Then, the patient was asked to reach as forward as (s)he can, without taking a step.
Again, the evaluator determined the position of the third metacarpal.
The difference in centimeters between the first and second marks determined the FRT value.
The FRT was performed three times and average value was taken.
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Naime Evrim Karadag-Saygi, Prof, Department of PM&R, Marmara University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 2, 2018
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
July 31, 2018
Study Registration Dates
First Submitted
January 16, 2020
First Submitted That Met QC Criteria
January 16, 2020
First Posted (Actual)
January 22, 2020
Study Record Updates
Last Update Posted (Estimate)
January 24, 2023
Last Update Submitted That Met QC Criteria
January 21, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 02.04.2018 - 112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Dyslexia
-
Catholic University of the Sacred HeartFondazione Policlinico Universitario Agostino Gemelli IRCCS; Fondazione I.R...Enrolling by invitationDevelopmental DyslexiaItaly
-
University of ZurichUnknown
-
Bambino Gesù Hospital and Research InstituteRecruitingDevelopmental DyslexiaItaly
-
Bambino Gesù Hospital and Research InstituteEnrolling by invitationDevelopmental DyslexiaItaly
-
Scalab CNRS 9193UnknownDevelopmental DyslexiaFrance
-
Catholic University of the Sacred HeartUnknown
-
University Hospital, ToursCompleted
-
IRCCS Eugenio MedeaFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; University of MilanRecruiting
-
Georgia State UniversityMedical University of South Carolina; National Institutes of Health (NIH)CompletedDevelopmental Reading Disorder | Dyslexia, DevelopmentalUnited States
-
Università Vita-Salute San RaffaeleRecruiting
Clinical Trials on Dynamic Gait Index
-
Marmara UniversityCompletedCerebral Palsy | Gait Disorders, Neurologic | Hemiplegic Cerebral PalsyTurkey
-
Riphah International UniversityCompletedFall | Old Age; DebilityPakistan
-
University Hospital, GhentUniversity GhentRecruitingStroke | Traumatic Brain Injury | Spinal Cord InjuriesBelgium
-
Hannover Medical SchoolUniversity of Sheffield; Ludwig-Maximilians - University of Munich; Heidelberg... and other collaboratorsUnknown
-
Universiti Tunku Abdul RahmanCompletedSarcopenia | Sarcopenic Obesity
-
Centre Hospitalier Universitaire de NiceCompleted
-
Baskent UniversityCompleted
-
Clea TuckerRecruitingMild Traumatic Brain InjuryUnited States
-
East Carolina UniversityCompletedCerebral PalsyUnited States
-
Cairo UniversityCompleted