Occupational TherapyNCT06871566
AI-Supported Occupational Therapy for Handwriting
A study testing Artificial Intelligence-Supported Occupational Therapy Program in people with Occupational Therapy, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This study investigates the impact of an AI-supported occupational therapy program, developed using the Model of Human Occupation (MOHO), on handwriting skills in children at risk for Developmental Coordination Disorder (DCD). Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Occupational Therapy
- What is being tested?
- Artificial Intelligence-Supported Occupational Therapy Program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Apr 2024to 30 Aug 2024
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- being between the ages of 8-12 years
- being at risk for DCD according to the Developmental Coordination Disorder Questionnaire (DCDQ)
- having the ability to understand the questionnaires
- continuing formal education
- having similar motor skill performance (having similar results from the Bruininks-Oseretsky Motor Proficiency Test 2 Brief Form (BOT2-BF)) and having similar visual perception level (having similar results from the Motor-Free Visual Perception Test-3(MVPT-3)
Who cannot join
- having another neurodevelopmental, orthopedic and chronic problem (2) continuing any rehabilitation program
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Intelligence-Supported Occupational Therapy Program on Handwriting Skills in Children at Risk for Developmental Coordination Disorder: Randomized Controlled Trial
Aim: This study investigates the impact of an AI-supported occupational therapy program, developed using the Model of Human Occupation (MOHO), on handwriting skills in children at risk for Developmental Coordination Disorder (DCD).
Method: A randomized controlled trial was conducted with 42 children aged 8-12 years, identified as being at risk for DCD using the Developmental Coordination Disorder Questionnaire (DCDQ). Participants were randomized into an intervention group (n=21) and a control group (n=21). The intervention group received an AI-supported occupational therapy program twice weekly for 8 weeks. Handwriting performance was assessed pre- and post-intervention using the Minnesota Handwriting Assessment (MHA).
Keywords: artificial intelligence, occupational
- Conditions
- Occupational Therapy
- Being tested
- Artificial Intelligence-Supported Occupational Therapy Program
- Keywords
- Artifical intellegence, occupational therapy, developmental coordination disorders, handwriting, rehabilitation
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence-Supported Occupational Therapy ProgramOther
The AI-supported occupational therapy program was individually implemented by an occupational therapist over 8 weeks, with 2 sessions per week, each lasting 45 minutes. A touchscreen tablet, touch pen, and external camera were utilized during the sessions. At the beginning of the program, technological devices and artificial intelligence tools were introduced to the children. For the goals and detailed intervention program of the 8-week schedule
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Children at Risk for Developmental Coordination Disorder Receives: Other: Artificial Intelligence-Supported Occupational Therapy Program |
| Control group | No intervention | Children at Risk for Developmental Coordination Disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minnesota Handwriting Assessment
(MHA) assesses six categories of handwriting, including legibility, form, alignment, size, spacing and writing speed. The MHA consists of words that include all letters of the Turkish alphabet at least once and consist of 34 letters in total, and can be understood by children at the primary school level 23. In the test application, children copy this word sequence written on the paper to the marked line immediately below. In the scoring phase, the length of 1/16 inch (0.15 cm) is taken as a basis and all deviations, proportions between letters and within letters are evaluated by measuring this length with a ruler. The lowest score in each category of the MHA is 0 and the highest score is 34 24.
Measured: Two assessments, one week before the intervention and one week after the intervention was completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start12 Apr 2024
- Primary completion20 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational TherapyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Güleser Güney Yılmaz, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871566
- Sponsor's protocol ID
- 2024-242
- Status last verified
- Mar 2025
- First submitted
- 22 Jan 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This study investigates the impact of an AI-supported occupational therapy program, developed using the Model of Human Occupation (MOHO), on handwriting skills in children at risk for Developmental Coordination Disorder (DCD).
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Supported Occupational Therapy Program on Handwriting Skills in Children at Risk for Developmental Coordination Disorder: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06871566
- Acronym / sponsor ID
- 2024-242
- Conditions
- Occupational Therapy
- Keywords
- Artifical intellegence, occupational therapy, developmental coordination disorders, handwriting, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 12 Mar 2025 (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.
Aim: This study investigates the impact of an AI-supported occupational therapy program, developed using the Model of Human Occupation (MOHO), on handwriting skills in children at risk for Developmental Coordination Disorder (DCD).
Method: A randomized controlled trial was conducted with 42 children aged 8-12 years, identified as being at risk for DCD using the Developmental Coordination Disorder Questionnaire (DCDQ). Participants were randomized into an intervention group (n=21) and a control group (n=21). The intervention group received an AI-supported occupational therapy program twice weekly for 8 weeks. Handwriting performance was assessed pre- and post-intervention using the Minnesota Handwriting Assessment (MHA).
Keywords: artificial intelligence, occupational
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: Artificial Intelligence-Supported Occupational Therapy ProgramChildren at Risk for Developmental Coordination Disorder |
| Control group | No intervention | –Children at Risk for Developmental Coordination Disorder |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- being between the ages of 8-12 years
- being at risk for DCD according to the Developmental Coordination Disorder Questionnaire (DCDQ)
- having the ability to understand the questionnaires
- continuing formal education
- having similar motor skill performance (having similar results from the Bruininks-Oseretsky Motor Proficiency Test 2 Brief Form (BOT2-BF)) and having similar visual perception level (having similar results from the Motor-Free Visual Perception Test-3(MVPT-3)
Key exclusion criteria (2 listed)
- having another neurodevelopmental, orthopedic and chronic problem (2) continuing any rehabilitation program
- -
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 |
|---|---|---|
| Artificial Intelligence-Supported Occupational Therapy ProgramThe AI-supported occupational therapy program was individually implemented by an occupational therapist over 8 weeks, with 2 sessions per week, each lasting 45 minutes. A touchscreen tablet, touch pen, and external camera were utilized during the sessions. At the beginning of the program, technological devices and artificial intelligence tools were introduced to the children. For the goals and detailed intervention program of the 8-week schedule | Other | Study group |
Primary outcome
Minnesota Handwriting Assessment
Time frame: Two assessments, one week before the intervention and one week after the intervention was completed
(MHA) assesses six categories of handwriting, including legibility, form, alignment, size, spacing and writing speed. The MHA consists of words that include all letters of the Turkish alphabet at least once and consist of 34 letters in total, and can be understood by children at the primary school level 23. In the test application, children copy this word sequence written on the paper to the marked line immediately below. In the scoring phase, the length of 1/16 inch (0.15 cm) is taken as a basis and all deviations, proportions between letters and within letters are evaluated by measuring this length with a ruler. The lowest score in each category of the MHA is 0 and the highest score is 34 24.
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 12 Mar 2025.
- Individual participant dataSharing planned: Undecided. This study investigates the impact of an AI-supported occupational therapy program, developed using the Model of Human Occupation (MOHO), on handwriting skills in children at risk for Developmental Coordination Disorder (DCD).
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence-Supported Occupational Therapy Program in people with Occupational Therapy, 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 5 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 12 Mar 2025. 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 Assessment (time frame: Two assessments, one week before the intervention and one week after the intervention was completed). 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 12 Mar 2025.