Specific Learning DisabilityNCT05319197
HAND FUNCTIONS OF CHILDREN WITH A SPECIFIC LEARNING DISORDER
An observational study of Specific Learning Disability and Specific Learning Disorder, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Children with Specific Learning Difficulties (SLD) may have problems with fine and gross motor skills compared to their healthy peers. These children may have poor manual dexterity. Taken together, it is not clear how motor and sensory competence of the hand are affected together. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Specific Learning Disability, Specific Learning Disorder, Fine Motor Skills
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2022to 15 Dec 2022
- 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 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The convenience sampling will implement for this cross-sectional study. Children who have a diagnoisis of special learning disability regarding DSM-V criteria and who attends the Specific Learning Difficulty Support Education Program of the Ministry of National Education regularly twice a week will screen for eligibility by their physician and were subsequently requested to participate in this study.
Who may be able to join
- To have a diagnosis of special learning disability (regarding DSM-V criteria)
- To be in the age range of 8-14
Who cannot join
- Any acute or chronic orthopedic or neurological disease that may affect walking performance,
- Any surgery within the last 6 months,
- Severe sensory (hearing, vision, etc.) impairment that prevents him/her from taking commands
- Cognitive and mental severe impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Özel Eğitim ve Rehabilitasyon Merkezi
Afyonkarahisar, 03000
About this study
Official title: INVESTIGATION OF HAND FUNCTIONS IN CHILDREN WITH SPECIFIC LEARNING DISORDER
Children with Specific Learning Difficulties (SLD) may have problems with fine and gross motor skills compared to their healthy peers. These children may have poor manual dexterity. Taken together, it is not clear how motor and sensory competence of the hand are affected together. In this study, it was aimed to evaluate the sensory and motor ability of the hand and to compare the examined parameters between the SLD group and the healthy control group.
Read the detailed description
Specific learning disability (SLD) is a common neurodevelopmental disorder that begins at school age and sometimes goes undetected until adulthood. Its incidence in school-aged children is about 5-15%. Children with SLD have difficulty in fulfilling academic qualifications. In addition, there are various problems with fine motor skills, motor-coordination, balance and gross motor skills.
Upper extremity speed and dexterity affect fine motor performance (as they involve manipulative tasks that require a certain amount of time and higher motor skills). In the literature, it is reported that manual dexterity is a stronger predictor than balance on the functional mobility of children with SLD, and it is emphasized that strategies to improve dexterity performance should be focused in interventions for fine motor skills for these children. In addition, it is demonstrated that taking the necessary precautions and planning by evaluating the gross and fine motor skills in detail in SLD is important for the independence and achievements of children in their daily living activities.
Weak hand skills are expected in children with SLD. Problems based on hand performance can be addressed in a more comprehensive way by comparing these children with children with typical development in terms of motor performance and functional mobility. Similarly, although it is recommended to evaluate senses such as touch and stereognosia when evaluating fine motor performance in these children, no comprehensive study including sensory and motor evaluations has been found in the literature.
In this study, in children with SLD; It is aimed to examine the limitations of hand motor and sensory functions in daily activities in terms of general motor competencies and hand skills of the child and to compare them with the healthy control group.
- Conditions
- Specific Learning Disability, Specific Learning Disorder, Fine Motor Skills, Hand Functions
- Being tested
- No Interventions
- Medical subject headings
- Specific Learning Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
No Interventions
| Study group | Role | What they receive |
|---|---|---|
| SLD Group | Not described Receives: Other: No Interventions | |
| Healthy Control Group | Not described Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruininks-Oseretsky Motor Proficiency Test- 2 Short Form (BOT-2SF)
Assesses fine motor precision, fine motor integration, and manual dexterity. Scores are reported as a percentile rank; higher scores indicate better fine motor skills.
Measured: 20 minutes
Hand Grip Force
Changes from the baseline, To measure hand grip strength through Hydraulic Hand held Dynamo-meter. It will be measured in kilograms.
Measured: 10 minutes
Pinch Grip Force
Participants were seated at a table on which the dynamometers were positioned. The subjects were told to keep their elbow flexed without resting their arm or the grip handle of the dynamometer on the table. Results will be evaluated in pounds.
Measured: 6 minutes
Abilhand Kids
to assess for performance of activity. score range 0-42 point, higher scores mean a better outcome.
Measured: 5 minutes
Minnesota Manual Dexterity Test
to assess manual dexterity, higher scores mean a worse outcome.
Measured: 25 minutes
Sensory Function
Proprioception, stereognosis, and two-point discrimination will be tested. Lower scores indicate better sensory function.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start5 May 2022
- Primary completion15 Sep 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific Learning DisabilityStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- İsmail SARAÇOĞLU, Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319197
- Sponsor's protocol ID
- KutahyaHSUozgulogrenmeguclugu
- Status last verified
- Apr 2022
- First submitted
- 31 Mar 2022
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATION OF HAND FUNCTIONS IN CHILDREN WITH SPECIFIC LEARNING DISORDER
- ClinicalTrials.gov ID
- NCT05319197
- Acronym / sponsor ID
- KutahyaHSUozgulogrenmeguclugu
- Conditions
- Specific Learning Disability, Specific Learning Disorder, Fine Motor Skills, Hand Functions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 8 Apr 2022 (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.
Children with Specific Learning Difficulties (SLD) may have problems with fine and gross motor skills compared to their healthy peers. These children may have poor manual dexterity. Taken together, it is not clear how motor and sensory competence of the hand are affected together. In this study, it was aimed to evaluate the sensory and motor ability of the hand and to compare the examined parameters between the SLD group and the healthy control group.
Detailed description
Specific learning disability (SLD) is a common neurodevelopmental disorder that begins at school age and sometimes goes undetected until adulthood. Its incidence in school-aged children is about 5-15%. Children with SLD have difficulty in fulfilling academic qualifications. In addition, there are various problems with fine motor skills, motor-coordination, balance and gross motor skills.
Upper extremity speed and dexterity affect fine motor performance (as they involve manipulative tasks that require a certain amount of time and higher motor skills). In the literature, it is reported that manual dexterity is a stronger predictor than balance on the functional mobility of children with SLD, and it is emphasized that strategies to improve dexterity performance should be focused in interventions for fine motor skills for these children. In addition, it is demonstrated that taking the necessary precautions and planning by evaluating the gross and fine motor skills in detail in SLD is important for the independence and achievements of children in their daily living activities.
Weak hand skills are expected in children with SLD. Problems based on hand performance can be addressed in a more comprehensive way by comparing these children with children with typical development in terms of motor performance and functional mobility. Similarly, although it is recommended to evaluate senses such as touch and stereognosia when evaluating fine motor performance in these children, no comprehensive study including sensory and motor evaluations has been found in the literature.
In this study, in children with SLD; It is aimed to examine the limitations of hand motor and sensory functions in daily activities in terms of general motor competencies and hand skills of the child and to compare them with the healthy control group.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLD Group | – | Other: No Interventions |
| Healthy Control Group | – | Other: No Interventions |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The convenience sampling will implement for this cross-sectional study. Children who have a diagnoisis of special learning disability regarding DSM-V criteria and who attends the Specific Learning Difficulty Support Education Program of the Ministry of National Education regularly twice a week will screen for eligibility by their physician and were subsequently requested to participate in this study.
Key inclusion criteria (2 listed)
- To have a diagnosis of special learning disability (regarding DSM-V criteria)
- To be in the age range of 8-14
Key exclusion criteria (4 listed)
- Any acute or chronic orthopedic or neurological disease that may affect walking performance,
- Any surgery within the last 6 months,
- Severe sensory (hearing, vision, etc.) impairment that prevents him/her from taking commands
- Cognitive and mental severe impairment
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 |
|---|---|---|
| No InterventionsNo Interventions | Other | Healthy Control Group, SLD Group |
Primary outcome
Bruininks-Oseretsky Motor Proficiency Test- 2 Short Form (BOT-2SF)
Time frame: 20 minutes
Assesses fine motor precision, fine motor integration, and manual dexterity. Scores are reported as a percentile rank; higher scores indicate better fine motor skills.
Hand Grip Force
Time frame: 10 minutes
Changes from the baseline, To measure hand grip strength through Hydraulic Hand held Dynamo-meter. It will be measured in kilograms.
Pinch Grip Force
Time frame: 6 minutes
Participants were seated at a table on which the dynamometers were positioned. The subjects were told to keep their elbow flexed without resting their arm or the grip handle of the dynamometer on the table. Results will be evaluated in pounds.
Abilhand Kids
Time frame: 5 minutes
to assess for performance of activity. score range 0-42 point, higher scores mean a better outcome.
Minnesota Manual Dexterity Test
Time frame: 25 minutes
to assess manual dexterity, higher scores mean a worse outcome.
Sensory Function
Time frame: 30 minutes
Proprioception, stereognosis, and two-point discrimination will be tested. Lower scores indicate better sensory function.
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 15 Oct 2024.
- 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.
İsmail SARAÇOĞLU principal investigator
Kutahya Health Sciences 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 Specific Learning Disability and Specific Learning Disorder, run by Kutahya Health Sciences 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 4 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 15 Oct 2024. 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?
Bruininks-Oseretsky Motor Proficiency Test- 2 Short Form (BOT-2SF) (time frame: 20 minutes). The study lists 6 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 15 Oct 2024.