DyslexiaNCT04386161
Static and Dynamic Balance in Children With Dyslexia
A study testing Scheduled exercise program in people with Dyslexia, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslexia
- What is being tested?
- Scheduled exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Dec 2018
- Phase
- Interventional
- 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 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosed with dyslexia by a child and adolescent psychiatrist
- WISC R test result in IQ> 85
Who cannot join
- Having hyperactivity disorder according to DSM-5
- Having a neuromuscular disease, skeletal anomaly, or vision and hearing problem
- Using an antipsychotic drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Static and Dynamic Balance Changes After a Scheduled Exercise Program in Children With Dyslexia
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.
Read the detailed description
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. It is an unexpected and permanent failure in gaining reading skills in the individual who have sufficient intelligence, socio-cultural opportunities, and education, according to the World Health Organization. The diagnosis can be made by a child and adolescent psychiatrist clinically or with the Diagnostics and Statistical Manual of mental disorders (DSM-5). The prevalence of dyslexia varies between 2-10%, and it is seen 3-4 times more in men than in women.
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. Frankle and Levinson suggested that there is a cerebellar-vestibular disorder in people with dyslexia for the first time in 1973. They found that 97% of 115 children with dyslexia abnormal neurological findings such as positive Romberg test, walking difficulty, speech disorder, or hypotonia. After then, Rae et al. reported that the right frontal lobe of the cerebellum was smaller, and there were distinct biochemical changes on the temporoparietal lobe in dyslexic individuals compared to healthy controls. Moe-Nilssen et al. showed that dyslexic children have impairment in both balance and gait ability. Barela et al. claimed that writing and learning disorders in dyslexia were associated with cerebellum. Patel et al. found that postural instability was related to the severity of dyslexia. Quercia et al. gave postural exercise treatment to the dyslexics, then examined their postural stability after a vibrational stimulation. The length and speed of CoG were shown to be significantly higher in untreated dyslexic patients compared to the treated dyslexics and the non-dyslexic group.
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.
- Conditions
- Dyslexia
- Being tested
- Scheduled exercise program
- Keywords
- Dyslexia, Balance, Exercise Program
- Medical subject headings
- Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduled exercise programOther
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
| Study group | Role | What they receive |
|---|---|---|
| Children with dyslexia | Experimental | Children, aged between 8 and 11 years, with clinical dyslexia diagnosed by a child and adolescent psychiatrist Receives: Other: Scheduled exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Week 6
Secondary outcomes (14)
Dynamic Balance Assessment, Reaction time
Reaction time of Limits of Stability (LOS) test
Measured: Day 0
Dynamic Balance Assessment, Reaction time
Reaction time of Limits of Stability (LOS) test
Measured: Week 6
Dynamic Balance Assessment, Movement time
Movement time of Limits of Stability (LOS) test
Measured: Day 0
Dynamic Balance Assessment, Movement time
Movement time of Limits of Stability (LOS) test
Measured: Week 6
Dynamic Balance Assessment, Endpoint excursion
Endpoint excursion of Limits of Stability (LOS) test
Measured: Day 0
Dynamic Balance Assessment, Endpoint excursion
Endpoint excursion of Limits of Stability (LOS) test
Measured: Week 6
Dynamic Balance Assessment, Maximum excursion
Maximum excursion of Limits of Stability (LOS) test
Measured: Day 0
Dynamic Balance Assessment, Maximum excursion
Maximum excursion of Limits of Stability (LOS) test
Measured: Week 6
Dynamic Balance Assessment, Direction control
Direction control of Limits of Stability (LOS) test
Measured: Day 0
Dynamic Balance Assessment, Direction control
Direction control of Limits of Stability (LOS) test
Measured: Week 6
Reading Performance
The number of correct and total words
Measured: Day 0
Reading Performance
The number of correct and total words
Measured: Week 6
Pediatric Quality of Life Inventory Scale
There are 23 questions in this scale and 5 options for each question, it takes a short time to complete and contains questions about physical, social, emotional and school functionality. For the questions, zero means that the person never had a problem, and four means that the person always has a problem.
Measured: Day 0
Pediatric Quality of Life Inventory Scale
There are 23 questions in this scale and 5 options for each question, it takes a short time to complete and contains questions about physical, social, emotional and school functionality. For the questions, zero means that the person never had a problem, and four means that the person always has a problem.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start1 Jan 2018
- Primary completion1 Jun 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslexiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Children, aged between 8 and 11 years, with clinical dyslexia diagnosed by a child and adolescent psychiatrist
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kardelen Gencer Atalay, Marmara University
- Investigators
- Evrim Karadag Saygi, Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04386161
- Sponsor's protocol ID
- 09.2017.672
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Static and Dynamic Balance Changes After a Scheduled Exercise Program in Children With Dyslexia
- ClinicalTrials.gov ID
- NCT04386161
- Acronym / sponsor ID
- 09.2017.672
- Conditions
- Dyslexia
- Keywords
- Dyslexia, Balance, Exercise Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 13 May 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.
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.
Detailed description
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. It is an unexpected and permanent failure in gaining reading skills in the individual who have sufficient intelligence, socio-cultural opportunities, and education, according to the World Health Organization. The diagnosis can be made by a child and adolescent psychiatrist clinically or with the Diagnostics and Statistical Manual of mental disorders (DSM-5). The prevalence of dyslexia varies between 2-10%, and it is seen 3-4 times more in men than in women.
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. Frankle and Levinson suggested that there is a cerebellar-vestibular disorder in people with dyslexia for the first time in 1973. They found that 97% of 115 children with dyslexia abnormal neurological findings such as positive Romberg test, walking difficulty, speech disorder, or hypotonia. After then, Rae et al. reported that the right frontal lobe of the cerebellum was smaller, and there were distinct biochemical changes on the temporoparietal lobe in dyslexic individuals compared to healthy controls. Moe-Nilssen et al. showed that dyslexic children have impairment in both balance and gait ability. Barela et al. claimed that writing and learning disorders in dyslexia were associated with cerebellum. Patel et al. found that postural instability was related to the severity of dyslexia. Quercia et al. gave postural exercise treatment to the dyslexics, then examined their postural stability after a vibrational stimulation. The length and speed of CoG were shown to be significantly higher in untreated dyslexic patients compared to the treated dyslexics and the non-dyslexic group.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Children, aged between 8 and 11 years, with clinical dyslexia diagnosed by a child and adolescent psychiatrist
| Arm | Type | Receives |
|---|---|---|
| Children with dyslexia | Experimental | Other: Scheduled exercise programChildren, aged between 8 and 11 years, with clinical dyslexia diagnosed by a child and adolescent psychiatrist |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosed with dyslexia by a child and adolescent psychiatrist
- WISC R test result in IQ> 85
Key exclusion criteria (3 listed)
- Having hyperactivity disorder according to DSM-5
- Having a neuromuscular disease, skeletal anomaly, or vision and hearing problem
- Using an antipsychotic drug
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 |
|---|---|---|
| Scheduled exercise program45 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 | Other | Children with dyslexia |
Primary outcome
Static Balance Assessment
Time frame: Day 0
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
Static Balance Assessment
Time frame: Week 6
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
14 secondary outcomes
Dynamic Balance Assessment, Reaction time
Time frame: Day 0
Dynamic Balance Assessment, Reaction time
Time frame: Week 6
Dynamic Balance Assessment, Movement time
Time frame: Day 0
Dynamic Balance Assessment, Movement time
Time frame: Week 6
Dynamic Balance Assessment, Endpoint excursion
Time frame: Day 0
Dynamic Balance Assessment, Endpoint excursion
Time frame: Week 6
Dynamic Balance Assessment, Maximum excursion
Time frame: Day 0
Dynamic Balance Assessment, Maximum excursion
Time frame: Week 6
Dynamic Balance Assessment, Direction control
Time frame: Day 0
Dynamic Balance Assessment, Direction control
Time frame: Week 6
Reading Performance
Time frame: Day 0
Reading Performance
Time frame: Week 6
Pediatric Quality of Life Inventory Scale
Time frame: Day 0
Pediatric Quality of Life Inventory Scale
Time frame: Week 6
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 19 May 2020.
- Individual participant dataSharing planned: No
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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.
Evrim Karadag Saygi study director
Marmara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scheduled exercise program in people with Dyslexia, 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 2 inclusion and 3 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 19 May 2020. 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?
Static Balance Assessment (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?
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 19 May 2020; AzTrials last refreshed its copy on 26 Oct 2026.