search
Back to results

Static and Dynamic Balance in Children With Dyslexia

Primary Purpose

Dyslexia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Scheduled exercise program
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslexia focused on measuring Dyslexia, Balance, Exercise Program

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Kardelen Gencer Atalay

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children with dyslexia

Arm Description

Children, aged between 8 and 11 years, with clinical dyslexia diagnosed by a child and adolescent psychiatrist

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Dynamic Balance Assessment, Reaction time
Reaction time of Limits of Stability (LOS) test
Dynamic Balance Assessment, Reaction time
Reaction time of Limits of Stability (LOS) test
Dynamic Balance Assessment, Movement time
Movement time of Limits of Stability (LOS) test
Dynamic Balance Assessment, Movement time
Movement time of Limits of Stability (LOS) test
Dynamic Balance Assessment, Endpoint excursion
Endpoint excursion of Limits of Stability (LOS) test
Dynamic Balance Assessment, Endpoint excursion
Endpoint excursion of Limits of Stability (LOS) test
Dynamic Balance Assessment, Maximum excursion
Maximum excursion of Limits of Stability (LOS) test
Dynamic Balance Assessment, Maximum excursion
Maximum excursion of Limits of Stability (LOS) test
Dynamic Balance Assessment, Direction control
Direction control of Limits of Stability (LOS) test
Dynamic Balance Assessment, Direction control
Direction control of Limits of Stability (LOS) test
Reading Performance
The number of correct and total words
Reading Performance
The number of correct and total words
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.
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.

Full Information

First Posted
May 5, 2020
Last Updated
May 16, 2020
Sponsor
Marmara University
search

1. Study Identification

Unique Protocol Identification Number
NCT04386161
Brief Title
Static and Dynamic Balance in Children With Dyslexia
Official Title
Static and Dynamic Balance Changes After a Scheduled Exercise Program in Children With Dyslexia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslexia
Keywords
Dyslexia, Balance, Exercise Program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Children, aged between 8 and 11 years, with clinical dyslexia diagnosed by a child and adolescent psychiatrist
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children with dyslexia
Arm Type
Experimental
Arm Description
Children, aged between 8 and 11 years, with clinical dyslexia diagnosed by a child and adolescent psychiatrist
Intervention Type
Other
Intervention Name(s)
Scheduled exercise program
Intervention Description
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
Primary Outcome Measure Information:
Title
Static Balance Assessment
Description
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
Time Frame
Day 0
Title
Static Balance Assessment
Description
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
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Dynamic Balance Assessment, Reaction time
Description
Reaction time of Limits of Stability (LOS) test
Time Frame
Day 0
Title
Dynamic Balance Assessment, Reaction time
Description
Reaction time of Limits of Stability (LOS) test
Time Frame
Week 6
Title
Dynamic Balance Assessment, Movement time
Description
Movement time of Limits of Stability (LOS) test
Time Frame
Day 0
Title
Dynamic Balance Assessment, Movement time
Description
Movement time of Limits of Stability (LOS) test
Time Frame
Week 6
Title
Dynamic Balance Assessment, Endpoint excursion
Description
Endpoint excursion of Limits of Stability (LOS) test
Time Frame
Day 0
Title
Dynamic Balance Assessment, Endpoint excursion
Description
Endpoint excursion of Limits of Stability (LOS) test
Time Frame
Week 6
Title
Dynamic Balance Assessment, Maximum excursion
Description
Maximum excursion of Limits of Stability (LOS) test
Time Frame
Day 0
Title
Dynamic Balance Assessment, Maximum excursion
Description
Maximum excursion of Limits of Stability (LOS) test
Time Frame
Week 6
Title
Dynamic Balance Assessment, Direction control
Description
Direction control of Limits of Stability (LOS) test
Time Frame
Day 0
Title
Dynamic Balance Assessment, Direction control
Description
Direction control of Limits of Stability (LOS) test
Time Frame
Week 6
Title
Reading Performance
Description
The number of correct and total words
Time Frame
Day 0
Title
Reading Performance
Description
The number of correct and total words
Time Frame
Week 6
Title
Pediatric Quality of Life Inventory Scale
Description
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.
Time Frame
Day 0
Title
Pediatric Quality of Life Inventory Scale
Description
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.
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evrim Karadag Saygi
Organizational Affiliation
Marmara University
Official's Role
Study Director
Facility Information:
Facility Name
Kardelen Gencer Atalay
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Static and Dynamic Balance in Children With Dyslexia

We'll reach out to this number within 24 hrs