- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04386161
Static and Dynamic Balance in Children With Dyslexia
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34899
- Kardelen Gencer Atalay
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosed with dyslexia by a child and adolescent psychiatrist
- WISC R test result in IQ> 85
Exclusion Criteria:
- Having hyperactivity disorder according to DSM-5
- Having a neuromuscular disease, skeletal anomaly, or vision and hearing problem
- Using an antipsychotic drug
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Children with dyslexia
Children, aged between 8 and 11 years, with clinical dyslexia diagnosed by a child and adolescent psychiatrist
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Static Balance Assessment
Time Frame: Day 0
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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
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Day 0
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Static Balance Assessment
Time Frame: Week 6
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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
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Week 6
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dynamic Balance Assessment, Reaction time
Time Frame: Day 0
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Reaction time of Limits of Stability (LOS) test
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Day 0
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Dynamic Balance Assessment, Reaction time
Time Frame: Week 6
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Reaction time of Limits of Stability (LOS) test
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Week 6
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Dynamic Balance Assessment, Movement time
Time Frame: Day 0
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Movement time of Limits of Stability (LOS) test
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Day 0
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Dynamic Balance Assessment, Movement time
Time Frame: Week 6
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Movement time of Limits of Stability (LOS) test
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Week 6
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Dynamic Balance Assessment, Endpoint excursion
Time Frame: Day 0
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Endpoint excursion of Limits of Stability (LOS) test
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Day 0
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Dynamic Balance Assessment, Endpoint excursion
Time Frame: Week 6
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Endpoint excursion of Limits of Stability (LOS) test
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Week 6
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Dynamic Balance Assessment, Maximum excursion
Time Frame: Day 0
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Maximum excursion of Limits of Stability (LOS) test
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Day 0
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Dynamic Balance Assessment, Maximum excursion
Time Frame: Week 6
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Maximum excursion of Limits of Stability (LOS) test
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Week 6
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Dynamic Balance Assessment, Direction control
Time Frame: Day 0
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Direction control of Limits of Stability (LOS) test
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Day 0
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Dynamic Balance Assessment, Direction control
Time Frame: Week 6
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Direction control of Limits of Stability (LOS) test
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Week 6
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Reading Performance
Time Frame: Day 0
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The number of correct and total words
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Day 0
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Reading Performance
Time Frame: Week 6
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The number of correct and total words
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Week 6
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Pediatric Quality of Life Inventory Scale
Time Frame: Day 0
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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.
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Day 0
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Pediatric Quality of Life Inventory Scale
Time Frame: Week 6
|
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.
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Week 6
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Evrim Karadag Saygi, Marmara University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2017.672
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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