DyslexiaNCT04235465
Dynamic Gait Index in Children With Dyslexia
An observational study of Dyslexia and Gait Disorders, Neurologic, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the present study is to investigate reliability in dyslexic children and compare it with healthy peers. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslexia, Gait Disorders, Neurologic
- What is being tested?
- Dynamic Gait Index
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2018to 31 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 30 dyslexia patients, between 8 - 14 years of age, and 30 healthy volunteer peers
Who may be able to join
- 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
Who cannot join
- Having cognitive disorder
- Having neuromuscular disorder
- Having skeletal anomaly
- Having visual or hearing problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Istanbul, 34890
About this study
Official title: 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.
Read the 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.
- Conditions
- Dyslexia, Gait Disorders, Neurologic
- Being tested
- Dynamic Gait Index
- Keywords
- Dynamic Gait Index, Reliability, Balance, Gait
- Medical subject headings
- Dyslexia, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Gait IndexOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Dynamic Gait Index | |
| Healthy Control Group | 30 healthy children will be included. Dynamic Gait Index will be performed. Receives: Other: Dynamic Gait Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Day 3
Secondary outcomes (2)
The Timed Up and Go Test
The Timed Up and Go is a test used to measure mobility and evaluates walking speed, posture control, functional mobility and balance.
Measured: Day 0
Functional Reach Test
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.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start2 Apr 2018
- Primary completion1 Jun 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naime Evrim Karadag-Saygi, Prof, Study chair, Department of PM&R, Marmara University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235465
- Sponsor's protocol ID
- 02.04.2018 - 112
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 21498044Cattaneo 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.
PubMed 17852286de 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.
PubMed 24960554Gouleme 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.
PubMed 26162071Kapoula 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.
PubMed 17676356
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of the Dynamic Gait Index in Children With Dyslexia
- ClinicalTrials.gov ID
- NCT04235465
- Acronym / sponsor ID
- 02.04.2018 - 112
- Conditions
- Dyslexia, Gait Disorders, Neurologic
- Keywords
- Dynamic Gait Index, Reliability, Balance, Gait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to investigate reliability in dyslexic children and compare it with healthy peers.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyslexia Group | – | Other: Dynamic Gait Index30 patients will be included. Dynamic Gait Index and other assessments will be performed twice with a 7-day interval by two evaluators |
| Healthy Control Group | – | Other: Dynamic Gait Index30 healthy children will be included. Dynamic Gait Index will be performed. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 30 dyslexia patients, between 8 - 14 years of age, and 30 healthy volunteer peers
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Having cognitive disorder
- Having neuromuscular disorder
- Having skeletal anomaly
- Having visual or hearing problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Gait IndexThe 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. | Other | Dyslexia Group, Healthy Control Group |
Primary outcome
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.
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.
2 secondary outcomes
The Timed Up and Go Test
Time frame: Day 0
Functional Reach Test
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Results publication: PubMed 21498044Barela 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.
- Results publication: PubMed 17852286Cattaneo 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.
- Results publication: PubMed 24960554de 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.
- Results publication: PubMed 26162071Gouleme 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.
- Results publication: PubMed 17676356Kapoula 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naime Evrim Karadag-Saygi, Prof study chair
Department of PM&R, Marmara University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslexia and Gait Disorders, Neurologic, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Dynamic Gait Index (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04235465, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.