Developmental DisabilityNCT04250701
Postural Control, Grip Strength and Body Posture in Children With Intellectual Disability and Dyslexia
An observational study of Developmental Disability and Developmental Dyslexia, run by Ahmet Emir at 1 site in Turkey (Türkiye).
Trial summary
This study investigates physical changes in children with Dyslexia and Intellectual Disability. Participants divided into three groups and Body Posture, Postural Control and Hand Grip Strengths was evaluated. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Disability, Developmental Dyslexia, Intellectual Disability
- What is being tested?
- Body Posture Assessment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2017to 26 Jun 2018
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Study population consisted children diagnosed with Dyslexia and Intellecutal Disability who continue their regular special education. The investigators also enrolled age matched typical developed children to establish control group
Who may be able to join
- no comorbid diagnosis alongside ID and Dyslexia (dysgraphia, dyscalculia, attention deficit hyperactivity disorder, etc.)
- no orthopedic/physical disability
Who cannot join
- Presence of previous training for physical or motor development
- Previous surgery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34815
About this study
Official title: Investigation of Postural Control, Grip Strength and Body Posture in Children With Intellectual Disability and Dyslexia
This study investigates physical changes in children with Dyslexia and Intellectual Disability. Participants divided into three groups and Body Posture, Postural Control and Hand Grip Strengths was evaluated.
Read the detailed description
Children with Intellectual Disability and Dyslexia have academic and behavioral problems but also they might have physical changes related to poor motor development.
Three evaluation method was used in study. Postural Deformities were evaluated by PostureScreen Mobile App which is a mobile app allows to assess photographic body posture in four aspects (anterior, posterior, lateral) Postural Control was tested by Wii Balance Board. Wii balance board is a force plate that can measure person's center of gravity displacements Hand grip strength tested by Jamar Hand Dynamometer. It was completed according to American Hand Therapist's Association guidelines.
All data collected from participants have analysed within the control group (typical developed children)
- Being tested
- Body Posture Assessment
- Keywords
- Postural Control,, Body Posture, Hand Grip
- Medical subject headings
- Developmental Disabilities, Dyslexia, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Posture AssessmentOther
Also called Postural Control Assessment, Hand Grip Strength Assessment
Application of three evaluations above at a one time.
| Study group | Role | What they receive |
|---|---|---|
| Dyslexia (D) | Not described Receives: Other: Body Posture Assessment | |
| Intellectual Disability (ID) | Not described Receives: Other: Body Posture Assessment | |
| Control (C) | Not described Receives: Other: Body Posture Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Posture Assessment
It is a photographic body posture assessment done by mobile app. It shows deviations of certain body parts such as head, shoulder, pelvis towards to gravitational line.
Measured: through study completion, an average of 1 year
Postural Control Evaluation
It is a wii balance board which can be used as a force plate. It tests displacements of Center of Pressure and Velocity of Center of Pressure and That gives an opinion about balance.
Measured: through study completion, an average of 1 year
Hand Grip Strength
It is a basic force measurement of hand grip with dynamometer
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start15 Feb 2017
- Primary completion10 Jan 2018
- Study completion26 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DisabilityStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmet Emir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmet Emir, Medipol University
- Investigators
- Ahmet Emir, Msc, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04250701
- Sponsor's protocol ID
- 10840098-604.01.01-E.4231
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2020
- Last updated
- 5 Feb 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Postural Control, Grip Strength and Body Posture in Children With Intellectual Disability and Dyslexia
- ClinicalTrials.gov ID
- NCT04250701
- Acronym / sponsor ID
- 10840098-604.01.01-E.4231
- Keywords
- Postural Control,, Body Posture, Hand Grip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Ahmet EmirUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 31 Jan 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.
This study investigates physical changes in children with Dyslexia and Intellectual Disability. Participants divided into three groups and Body Posture, Postural Control and Hand Grip Strengths was evaluated.
Detailed description
Children with Intellectual Disability and Dyslexia have academic and behavioral problems but also they might have physical changes related to poor motor development.
Three evaluation method was used in study. Postural Deformities were evaluated by PostureScreen Mobile App which is a mobile app allows to assess photographic body posture in four aspects (anterior, posterior, lateral) Postural Control was tested by Wii Balance Board. Wii balance board is a force plate that can measure person's center of gravity displacements Hand grip strength tested by Jamar Hand Dynamometer. It was completed according to American Hand Therapist's Association guidelines.
All data collected from participants have analysed within the control group (typical developed children)
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dyslexia (D) | – | Other: Body Posture Assessment |
| Intellectual Disability (ID) | – | Other: Body Posture Assessment |
| Control (C) | – | Other: Body Posture Assessment |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study population consisted children diagnosed with Dyslexia and Intellecutal Disability who continue their regular special education. The investigators also enrolled age matched typical developed children to establish control group
Key inclusion criteria (2 listed)
- no comorbid diagnosis alongside ID and Dyslexia (dysgraphia, dyscalculia, attention deficit hyperactivity disorder, etc.)
- no orthopedic/physical disability
Key exclusion criteria (2 listed)
- Presence of previous training for physical or motor development
- Previous surgery.
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 |
|---|---|---|
| Body Posture AssessmentAlso: Postural Control Assessment, Hand Grip Strength AssessmentApplication of three evaluations above at a one time. | Other | Control (C), Dyslexia (D), Intellectual Disability (ID) |
Primary outcome
Body Posture Assessment
Time frame: through study completion, an average of 1 year
It is a photographic body posture assessment done by mobile app. It shows deviations of certain body parts such as head, shoulder, pelvis towards to gravitational line.
Postural Control Evaluation
Time frame: through study completion, an average of 1 year
It is a wii balance board which can be used as a force plate. It tests displacements of Center of Pressure and Velocity of Center of Pressure and That gives an opinion about balance.
Hand Grip Strength
Time frame: through study completion, an average of 1 year
It is a basic force measurement of hand grip with dynamometer
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 5 Feb 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.
Ahmet Emir, Msc principal investigator
Medipol 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 Developmental Disability and Developmental Dyslexia, run by Ahmet Emir 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 2 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 5 Feb 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?
Body Posture Assessment (time frame: through study completion, an average of 1 year). 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 5 Feb 2020.