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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Turkey (Türkiye)1 site
  • Kardelen Gencer Atalay

    Istanbul, 34899

Other trials in Turkey (Türkiye)

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 groups in NCT04386161
Study groupRoleWhat they receive
Children with dyslexiaExperimentalChildren, 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.

  1. 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

  2. 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)
  1. Dynamic Balance Assessment, Reaction time

    Reaction time of Limits of Stability (LOS) test

    Measured: Day 0

  2. Dynamic Balance Assessment, Reaction time

    Reaction time of Limits of Stability (LOS) test

    Measured: Week 6

  3. Dynamic Balance Assessment, Movement time

    Movement time of Limits of Stability (LOS) test

    Measured: Day 0

  4. Dynamic Balance Assessment, Movement time

    Movement time of Limits of Stability (LOS) test

    Measured: Week 6

  5. Dynamic Balance Assessment, Endpoint excursion

    Endpoint excursion of Limits of Stability (LOS) test

    Measured: Day 0

  6. Dynamic Balance Assessment, Endpoint excursion

    Endpoint excursion of Limits of Stability (LOS) test

    Measured: Week 6

  7. Dynamic Balance Assessment, Maximum excursion

    Maximum excursion of Limits of Stability (LOS) test

    Measured: Day 0

  8. Dynamic Balance Assessment, Maximum excursion

    Maximum excursion of Limits of Stability (LOS) test

    Measured: Week 6

  9. Dynamic Balance Assessment, Direction control

    Direction control of Limits of Stability (LOS) test

    Measured: Day 0

  10. Dynamic Balance Assessment, Direction control

    Direction control of Limits of Stability (LOS) test

    Measured: Week 6

  11. Reading Performance

    The number of correct and total words

    Measured: Day 0

  12. Reading Performance

    The number of correct and total words

    Measured: Week 6

  13. 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

  14. 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.

  1. First posted13 May 2020
  2. Study start1 Jan 2018
  3. Primary completion1 Jun 2018
  4. Study completion1 Dec 2018

Resources

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)
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

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.

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