Specific Learning DisorderNCT04783987
Single and Dual Task Gait Parameters in Children With Specific Learning Difficulties
An observational study of Specific Learning Disorder and Gait, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Children with spesific learning disorders have differences in motor and cognitive abilities compared to normal developing children. Motor tasks as walking are not just have a motor components and also require a cognitive process to realize. Therefore cognitive abilities may effect motor performance. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Specific Learning Disorder, Gait
- What is being tested?
- Walking asessments
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to Aug 2022
- 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 6 to 17 years
- All sexes
- Child
Study population: The case group of children between the ages of 6-17 who has been diagnosed with Specific Learning Difficulty and who attends the Specific Learning Difficulty Support Education Program of the Ministry of National Education regularly twice a week; It is planned that a healthy children between the ages of 6-17 will form the control group.
Who may be able to join
- Case Group
- To be in the age range of 6-17
- To have a diagnosis of special learning disability Control Group
- To be in the age range of 6-17
- To be physically, mentally and psychologically healthy
Who cannot join
- Any acute or chronic orthopedic or neurological disease that may affect walking performance,
- Any surgery within the last 6 months,
- A hearing impairment that cannot be corrected with a hearing aid
- A visual impairment that cannot be corrected with glasses.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Afyonkarahisar Health Science University
Afyonkarahisar, 03030
EMEL TAŞVURAN HORATA, PhD, 05547759663, ethorata@gmail.com
Emel TAŞVURAN HORATA, PhD
About this study
Official title: Gait Parameters Under Single and Dual Task Conditions in Children With Specific Learning Difficulties: A Case-control Study
Children with spesific learning disorders have differences in motor and cognitive abilities compared to normal developing children.
Motor tasks as walking are not just have a motor components and also require a cognitive process to realize. Therefore cognitive abilities may effect motor performance.
Read more
In daily life, individuals perform dual or multitasks instead of single tasks naturally. Dual task is defined as the concurrent performance of two tasks that can be performed independently. Also dual tasks may be created from different tasks combinations such as a motor-motor dual task or motor-cognitive dual task.
Therefore, aim of the study is to compare gait parameters with healthy controls in single and dual task conditions in children with Special Learning Difficulties.
Read the detailed description
The fifth edition of the The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) opted for a categorical approach that introduced the Specific Learning Difficulties. Accordingly, it is thought that specific learning difficulties include many characteristics such as genetic risk, environmental risk factors, developmental characteristics, comorbidity and cognitive weaknesses. According to DSM-5, Specific Learning Difficulties are difficulties in using learning and school skills, which last at least six months, and are characterized by the presence of at least one of the following symptoms, despite the necessary attempts:
- Slowness and mistakes in reading words
- Difficulties in reading comprehension
- Problems with spelling
- Written expression difficulties
- Number perception and calculation problems experienced
- Numerical reasoning problems. In the literature, there are explanations about many cognitive limitations in children with specific learning difficulties, such as information processing, perceptual motor skills, processing of visual stimuli, phonological approach and the theory of cerebellum disorder. All of these cognitive limitations can also affect the dual task performance of these children.
In daily life, individuals perform dual or multitasks instead of single tasks naturally. Dual task is defined as the concurrent performance of two tasks that can be performed independently. Also dual tasks may be created from different tasks combinations such as a motor-motor dual task or motor-cognitive dual task.
However, no study investigating the effect of specific learning difficulties on walking parameters in single and dual task conditions has been found. In the light of the information is obtained from the literature, the gait parameters of children diagnosed with specific learning difficulties in single and dual task conditions may differ from the healthy control group. Therefore, this study's primary goal is to compare gait parameters in single and dual task conditions in children with Special Learning Disabilities with healthy controls.
- Conditions
- Specific Learning Disorder, Gait
- Being tested
- Walking asessments
- Medical subject headings
- Specific Learning Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking asessmentsOther
Also called 10 meter walking Test
Gait parameters will be evaluated in single and dual task conditions with 10 Meter Walk Test and wireless digital miniature portable walking and movement analyzer.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Group | Walking Assessments will be practised under dual and single task conditions. Receives: Other: Walking asessments | |
| Case Group | Walking Assessments will be practised under dual and single task conditions. Receives: Other: Walking asessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
The time it takes to walk a specified distance
Measured: 15 minutes
Cadance
number of steps per minute
Measured: 15 minutes
Strength length
It is the distance between points where the same heel touches the ground twice in a row.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Feb 2021
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific Learning DisorderStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Taşvuran Horata, Afyonkarahisar Health Sciences University
- Investigators
- Emel TAŞVURAN HORATA, PhD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783987
- Sponsor's protocol ID
- 2020/333
- Status last verified
- Jan 2022
- First submitted
- 2 Mar 2021
- Last updated
- 25 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Parameters Under Single and Dual Task Conditions in Children With Specific Learning Difficulties: A Case-control Study
- ClinicalTrials.gov ID
- NCT04783987
- Acronym / sponsor ID
- 2020/333
- Conditions
- Specific Learning Disorder, Gait
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 5 Mar 2021 (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.
Children with spesific learning disorders have differences in motor and cognitive abilities compared to normal developing children.
Motor tasks as walking are not just have a motor components and also require a cognitive process to realize. Therefore cognitive abilities may effect motor performance.
In daily life, individuals perform dual or multitasks instead of single tasks naturally. Dual task is defined as the concurrent performance of two tasks that can be performed independently. Also dual tasks may be created from different tasks combinations such as a motor-motor dual task or motor-cognitive dual task.
Therefore, aim of the study is to compare gait parameters with healthy controls in single and dual task conditions in children with Special Learning Difficulties.
Detailed description
The fifth edition of the The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) opted for a categorical approach that introduced the Specific Learning Difficulties. Accordingly, it is thought that specific learning difficulties include many characteristics such as genetic risk, environmental risk factors, developmental characteristics, comorbidity and cognitive weaknesses. According to DSM-5, Specific Learning Difficulties are difficulties in using learning and school skills, which last at least six months, and are characterized by the presence of at least one of the following symptoms, despite the necessary attempts:
- Slowness and mistakes in reading words
- Difficulties in reading comprehension
- Problems with spelling
- Written expression difficulties
- Number perception and calculation problems experienced
- Numerical reasoning problems. In the literature, there are explanations about many cognitive limitations in children with specific learning difficulties, such as information processing, perceptual motor skills, processing of visual stimuli, phonological approach and the theory of cerebellum disorder. All of these cognitive limitations can also affect the dual task performance of these children.
In daily life, individuals perform dual or multitasks instead of single tasks naturally. Dual task is defined as the concurrent performance of two tasks that can be performed independently. Also dual tasks may be created from different tasks combinations such as a motor-motor dual task or motor-cognitive dual task.
However, no study investigating the effect of specific learning difficulties on walking parameters in single and dual task conditions has been found. In the light of the information is obtained from the literature, the gait parameters of children diagnosed with specific learning difficulties in single and dual task conditions may differ from the healthy control group. Therefore, this study's primary goal is to compare gait parameters in single and dual task conditions in children with Special Learning Disabilities with healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Group | – | Other: Walking asessmentsWalking Assessments will be practised under dual and single task conditions. |
| Case Group | – | Other: Walking asessmentsWalking Assessments will be practised under dual and single task conditions. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- The case group of children between the ages of 6-17 who has been diagnosed with Specific Learning Difficulty and who attends the Specific Learning Difficulty Support Education Program of the Ministry of National Education regularly twice a week; It is planned that a healthy children between the ages of 6-17 will form the control group.
Key inclusion criteria (5 listed)
- Case Group
- To be in the age range of 6-17
- To have a diagnosis of special learning disability Control Group
- To be in the age range of 6-17
- To be physically, mentally and psychologically healthy
Key exclusion criteria (4 listed)
- Any acute or chronic orthopedic or neurological disease that may affect walking performance,
- Any surgery within the last 6 months,
- A hearing impairment that cannot be corrected with a hearing aid
- A visual impairment that cannot be corrected with glasses.
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 |
|---|---|---|
| Walking asessmentsAlso: 10 meter walking TestGait parameters will be evaluated in single and dual task conditions with 10 Meter Walk Test and wireless digital miniature portable walking and movement analyzer. | Other | Case Group, Healthy Control Group |
Primary outcome
Gait speed
Time frame: 15 minutes
The time it takes to walk a specified distance
Cadance
Time frame: 15 minutes
number of steps per minute
Strength length
Time frame: 15 minutes
It is the distance between points where the same heel touches the ground twice in a row.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
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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.
Emel TAŞVURAN HORATA, PhD principal investigator
Afyonkarahisar Health Sciences University
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 Specific Learning Disorder and Gait, run by Afyonkarahisar Health Sciences 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: status not confirmed, as of the sponsor's last update on 25 Jan 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact EMEL TAŞVURAN HORATA, PhD (05547759663, ethorata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2022.