HandwritingNCT04697771
Effect of Telerehabilitation on Handwriting Performance in Children With ADHD: RCT
A study testing Fine Motor Skills Training in people with Handwriting and Telerehabilitation, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
This is a randomized controlled study examining the effect of telerehabilitation on fine motor performance and handwriting difficulties experienced by children with attention deficit hyperactivity disorder. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Handwriting, Telerehabilitation, Fine Motor Skills
- What is being tested?
- Fine Motor Skills Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 28 Dec 2022
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- To be in the age range of 6-8,
- Diagnosed with Attention Deficit Hyperactivity Disorder-Predominantly Inattentive subtype according to DSM-5 and ADHD Rating Scale-5,
- Continuing individual education,
- After being informed about the study have agreed to participate in the study.
Who cannot join
- Children with an additional physical and neurological problem to accompany
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Ankara - Altındağ, 06
About this study
Official title: The Effect of Telerahabilitation on Fine Motor Skills and Writing Performance in Children With Attention Deficit and Hyperactivity Disorder: A Randomized Controlled Study
This is a randomized controlled study examining the effect of telerehabilitation on fine motor performance and handwriting difficulties experienced by children with attention deficit hyperactivity disorder.
Read the detailed description
It is planned that 40 children between the ages of 6-8 diagnosed with attention deficit and hyperactivity disorder and their families will participate voluntarily. An informed consent form, BOT-2 and Minnesota Handwriting Test will be sent to volunteer participants via e-mail. An evaluation session on Zoom application will be held for each participant with the participation of the occupational therapist, child and family. After the evaluation, the participants will be randomized and allocated to study and control groups.
Fine motor skills training will be given to the study group 3 sessions a week. The training will be given on the Zoom application and the duration is 8 weeks. At the end of 8 weeks, the evaluation will be done again with BOT-2 and Minnesota Handwriting Test.
The control group will be evaluated with BOT-2 and Minnesota Handwriting Test for the second time after waiting 8 weeks and will receive fine motor skills training.
- Conditions
- Handwriting, Telerehabilitation, Fine Motor Skills
- Being tested
- Fine Motor Skills Training
- Keywords
- ADHD, Handwriting, Occupational Therapy, Telerehabilitation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine Motor Skills TrainingOther
The fine motor skills training program was planned for the areas of difficulty that children with ADHD experience in the fine motor area as stated in the literature (Lavasani \& Stagnitti, 2011). The fine motor goals were organized for 8 weeks, each week including a different fine motor area and practicing handwriting. For each fine motor goal, 3 different activities were identified that did not require materials or could be practiced with materials that could be easily found in each child's home. For example, for the fine motor strengthening goal, three different activities were planned for the same purpose with tools such as play dough, nails, and staples (Case-Smith \& O'Brien, 2013). The activities determined each week were repeated three days a week in the same way and applied to all children. Within the 40-minute session, each activity was performed for 10 minutes under the guidance of an expert occupational therapist.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | First Evaluation - Fine Motor Skills Training - 8 week - 3 session per week - 40 minute per session - Second Evaluation Receives: Other: Fine Motor Skills Training |
| Control Group | No intervention | First Evaluation - 8 week waiting period - Second Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minnesota Handwriting Test
It evaluates six categories, including legibility, form, alignment, size, spacing, and rate
Measured: 5 minute
Secondary outcomes (1)
Bruininks-Oseretsky Motor Proficiency Test- 2 Short Form (BOT-2)
The test has been produced as a motor function assessment tool that can be applied to children in a short time.
Fine motor accuracy, fine motor integration, dexterity, bilateral coordination and upper extremity coordination sub-parameters of the test will be applied.
Measured: 15 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Dec 2020
- Primary completion30 Nov 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HandwritingStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomly divided into two groups. The same intervention will be applied to the second group after the first group has received intervention for 8 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Busra Kaplan Kilic, Hacettepe University
- Investigators
- Gonca Bumin, Prof, Study director, Hacettepe UniversityHakan Öğütlü, Msc, Study director, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697771
- Sponsor's protocol ID
- E1-20-1038
- Status last verified
- Feb 2024
- First submitted
- 28 Dec 2020
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Telerahabilitation on Fine Motor Skills and Writing Performance in Children With Attention Deficit and Hyperactivity Disorder: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04697771
- Acronym / sponsor ID
- E1-20-1038
- Conditions
- Handwriting, Telerehabilitation, Fine Motor Skills
- Keywords
- ADHD, Handwriting, Occupational Therapy, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 6 Jan 2021 (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 is a randomized controlled study examining the effect of telerehabilitation on fine motor performance and handwriting difficulties experienced by children with attention deficit hyperactivity disorder.
Detailed description
It is planned that 40 children between the ages of 6-8 diagnosed with attention deficit and hyperactivity disorder and their families will participate voluntarily. An informed consent form, BOT-2 and Minnesota Handwriting Test will be sent to volunteer participants via e-mail. An evaluation session on Zoom application will be held for each participant with the participation of the occupational therapist, child and family. After the evaluation, the participants will be randomized and allocated to study and control groups.
Fine motor skills training will be given to the study group 3 sessions a week. The training will be given on the Zoom application and the duration is 8 weeks. At the end of 8 weeks, the evaluation will be done again with BOT-2 and Minnesota Handwriting Test.
The control group will be evaluated with BOT-2 and Minnesota Handwriting Test for the second time after waiting 8 weeks and will receive fine motor skills training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly divided into two groups. The same intervention will be applied to the second group after the first group has received intervention for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Fine Motor Skills TrainingFirst Evaluation - Fine Motor Skills Training - 8 week - 3 session per week - 40 minute per session - Second Evaluation |
| Control Group | No intervention | –First Evaluation - 8 week waiting period - Second Evaluation |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- To be in the age range of 6-8,
- Diagnosed with Attention Deficit Hyperactivity Disorder-Predominantly Inattentive subtype according to DSM-5 and ADHD Rating Scale-5,
- Continuing individual education,
- After being informed about the study have agreed to participate in the study.
Key exclusion criteria (1 listed)
- Children with an additional physical and neurological problem to accompany
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 |
|---|---|---|
| Fine Motor Skills TrainingThe fine motor skills training program was planned for the areas of difficulty that children with ADHD experience in the fine motor area as stated in the literature (Lavasani \& Stagnitti, 2011). The fine motor goals were organized for 8 weeks, each week including a different fine motor area and practicing handwriting. For each fine motor goal, 3 different activities were identified that did not require materials or could be practiced with materials that could be easily found in each child's home. For example, for the fine motor strengthening goal, three different activities were planned for the same purpose with tools such as play dough, nails, and staples (Case-Smith \& O'Brien, 2013). The activities determined each week were repeated three days a week in the same way and applied to all children. Within the 40-minute session, each activity was performed for 10 minutes under the guidance of an expert occupational therapist. | Other | Intervention Group |
Primary outcome
Minnesota Handwriting Test
Time frame: 5 minute
It evaluates six categories, including legibility, form, alignment, size, spacing, and rate
1 secondary outcome
Bruininks-Oseretsky Motor Proficiency Test- 2 Short Form (BOT-2)
Time frame: 15 minute
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 20 Feb 2024.
Related trials for Handwriting
RecruitingObservational study
Neurodegenerative Diseases Progression Markers (MARKERS-NDD)
Neurodegenerative Diseases, Parkinson Disease
Recruiting
Effect of Functional Electrical Stimulation (FES) on Handwriting Rehabilitation After Acquired Brain Injury (ABI)
Acquired Brain Injury Including Stroke
Not yet recruiting
Structured Task-Focused Occupational Therapy in the School Environment to Support Academic Performance: Fine Motor and Visual-Motor Skills
Visual Perception, Visual-Motor Integration
Enrolling by invitation
Task-Oriented Writing Intervention for Preschoolers
Preschool Child, Handwriting
Not yet recruiting
Effect of Marble Play on Handgrip Strength and Handwriting Among School Going Children.
Hand Grasp
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.
Gonca Bumin, Prof study director
Hacettepe University
Hakan Öğütlü, Msc study director
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fine Motor Skills Training in people with Handwriting and Telerehabilitation, run by Hacettepe 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 4 inclusion and 1 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 20 Feb 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?
Minnesota Handwriting Test (time frame: 5 minute). 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 20 Feb 2024.