Difficulty WritingNCT05217394
Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Children
A study testing OTHIG in people with Difficulty Writing, run by National University of Malaysia at 4 sites in Malaysia.
Trial summary
This study aims to evaluate the effectiveness of the Occupational Therapy Handwriting Interventions Guidelines (OTHIG) in enhancing handwriting performance among children. Method: Forty-two children recruited from private centers with occupational therapy indications and with handwriting issues, aged five to nine… Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Difficulty Writing
- What is being tested?
- OTHIG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 4 sitesMalaysia
- Study dates
- 1 Oct 2021to 28 Feb 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- age between five and nine years
- engaged in OTs intervention either in an individual or group session.
Who cannot join
- refuse to participate in the study
- fail to comply with the whole intervention process during the study
- present severe sensory problems
- present poor behavior during intervention
Trial locations and contacts
4 sites in 1 country.
Malaysia4 sites
Excel Qhalif Playgroup Centre
Bangi, Selangor
Kiddie Care Centre
Jitra, Kedah, 06000
Ryan Special Needs Rehabilitation Centre
Putrajaya, PU, 62150
Kizzu Kids Centre
Shah Alam, Selangor
About this study
Official title: Evaluating the Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Handwriting Skills for Children: A Protocol for Clustered-Randomised Control Trial
This study aims to evaluate the effectiveness of the Occupational Therapy Handwriting Interventions Guidelines (OTHIG) in enhancing handwriting performance among children.
Method:
Read more
Forty-two children recruited from private centers with occupational therapy indications and with handwriting issues, aged five to nine years, will be assigned to the experimental and control groups.
Participants will receive a total of 10-week sessions, including training, intervention, and outcome measures.
The experimental group will receive the developed OTHIG during handwriting skills intervention. Meanwhile, the control group will receive conventional interventions which not exposed to the OTHIG.
This study is expected to provide evidence for the effectiveness of using the developed OTHIG to OTs in delivering their services, targeting children struggling with handwriting skills.
Read the detailed description
The study is a Cluster Randomised Controlled Trial (C-RCT) that systematically clusters the centers into the treatment and control groups.
A total of 10 centers will be involved in this study.
The clustering of all ten centers will allocate randomly into the treatment and control groups based on submitting the consent letter to the researcher and after an assessment of TPT and TVPS-4 are conducted.
Ten early interventions have similar characteristics such as (1) hiring graduated occupational therapists from recognized universities in Malaysia, (2) having occupational therapists working daily at the centre, (3) having children aged five to nine years who receive OTs intervention.
This randomization will be allocated based on the list of the centers that give an early submission of a signed consent form. The randomization will be carried out with a mechanism that neither the researcher nor children or center owners will know which group of intervention they will be assigned.
- Conditions
- Difficulty Writing
- Being tested
- OTHIG
- Keywords
- handwriting, intervention, effectiveness, children, study protocol, clustered randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTHIGOther
Occupational Therapy Handwriting Intervention Guideline
| Study group | Role | What they receive |
|---|---|---|
| OTHIG | Experimental | Occupational Therapy Handwriting Intervention Guideline - this is the experimental guideline to be tested in this study.
Section C: Intervention for Handwriting Readiness Skills
* Handwriting development
* Pre-writing skills
* Gross motor skills activities
* Fine motor skills activities
* Motor visual skills activities Section D: Intervention for Handwriting Skills
* Handwriting tools
* Pencil grasp
* Posture and position
* Hand dominance
* Writing capitals, lowercase, and numbers
* Handwriting speed Section E: Handwriting Intervention Module
* Session 1: Development of Handwriting Skills Activities
* Session 2: Pre-writing Skills Activities
* Session 3: Gross and Fine Motor Skills Activities
* Session 4: Writing Capital Letters
* Session 5: Writing Lowercase Letters
* Session 6: Writing Numbers Receives: Other: OTHIG |
| NOTi | No intervention | Natural Occupational Therapy Intervention - this means, the participants in this group are not exposed to the OTHIG. They receive natural OT intervention without exposure to the OTHIG. The natural OT intervention includes: Gross motor skills, fine motor skills, pre-writing skills, basic handwriting tasks such as copying, tracing, imitating and colouring. It will follow the occupational therapist intervention set up by the respected therapist in charge. The OT in charge had qualifications from the local university in Malaysia. The natural OT intervention includes: Gross motor skills, fine motor skills, pre-writing skills, basic handwriting tasks such as copying, tracing, imitating and colouring. It will follow the occupational therapist intervention set up by the respected therapist in charge. The OT in charge had qualifications from the local university in Malaysia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Print Tool
Handwriting assessment
Measured: 2 weeks
Secondary outcomes (1)
Test of Visual Perceptual Skills-4
Visual perceptual skills assessment
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Oct 2021
- Primary completion1 Dec 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficulty WritingStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Malaysia
- Responsible party
- Sponsor
- Investigators
- Masne Kadar, Study director, Faculty of Health Sciences, UKM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217394
- Sponsor's protocol ID
- FRGS/1/2020/SSI0/UKM/03/2
- Status last verified
- Nov 2022
- First submitted
- 9 Jan 2022
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected will be shared among researchers
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Handwriting Skills for Children: A Protocol for Clustered-Randomised Control Trial
- ClinicalTrials.gov ID
- NCT05217394
- Acronym / sponsor ID
- FRGS/1/2020/SSI0/UKM/03/2
- Conditions
- Difficulty Writing
- Keywords
- handwriting, intervention, effectiveness, children, study protocol, clustered randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Education, Malaysia
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 1 Feb 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.
This study aims to evaluate the effectiveness of the Occupational Therapy Handwriting Interventions Guidelines (OTHIG) in enhancing handwriting performance among children.
Method:
Forty-two children recruited from private centers with occupational therapy indications and with handwriting issues, aged five to nine years, will be assigned to the experimental and control groups.
Participants will receive a total of 10-week sessions, including training, intervention, and outcome measures.
The experimental group will receive the developed OTHIG during handwriting skills intervention. Meanwhile, the control group will receive conventional interventions which not exposed to the OTHIG.
This study is expected to provide evidence for the effectiveness of using the developed OTHIG to OTs in delivering their services, targeting children struggling with handwriting skills.
Detailed description
The study is a Cluster Randomised Controlled Trial (C-RCT) that systematically clusters the centers into the treatment and control groups.
A total of 10 centers will be involved in this study.
The clustering of all ten centers will allocate randomly into the treatment and control groups based on submitting the consent letter to the researcher and after an assessment of TPT and TVPS-4 are conducted.
Ten early interventions have similar characteristics such as (1) hiring graduated occupational therapists from recognized universities in Malaysia, (2) having occupational therapists working daily at the centre, (3) having children aged five to nine years who receive OTs intervention.
This randomization will be allocated based on the list of the centers that give an early submission of a signed consent form. The randomization will be carried out with a mechanism that neither the researcher nor children or center owners will know which group of intervention they will be assigned.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OTHIG | Experimental | Other: OTHIGOccupational Therapy Handwriting Intervention Guideline - this is the experimental guideline to be tested in this study. Section C: Intervention for Handwriting Readiness Skills * Handwriting development * Pre-writing skills * Gross motor skills activities * Fine motor skills activities * Motor visual skills activities Section D: Intervention for Handwriting Skills * Handwriting tools * Pencil grasp * Posture and position * Hand dominance * Writing capitals, lowercase, and numbers * Handwriting speed Section E: Handwriting Intervention Module * Session 1: Development of Handwriting Skills Activities * Session 2: Pre-writing Skills Activities * Session 3: Gross and Fine Motor Skills Activities * Session 4: Writing Capital Letters * Session 5: Writing Lowercase Letters * Session 6: Writing Numbers |
| NOTi | No intervention | –Natural Occupational Therapy Intervention - this means, the participants in this group are not exposed to the OTHIG. They receive natural OT intervention without exposure to the OTHIG. The natural OT intervention includes: Gross motor skills, fine motor skills, pre-writing skills, basic handwriting tasks such as copying, tracing, imitating and colouring. It will follow the occupational therapist intervention set up by the respected therapist in charge. The OT in charge had qualifications from the local university in Malaysia. The natural OT intervention includes: Gross motor skills, fine motor skills, pre-writing skills, basic handwriting tasks such as copying, tracing, imitating and colouring. It will follow the occupational therapist intervention set up by the respected therapist in charge. The OT in charge had qualifications from the local university in Malaysia. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- age between five and nine years
- engaged in OTs intervention either in an individual or group session.
Key exclusion criteria (4 listed)
- refuse to participate in the study
- fail to comply with the whole intervention process during the study
- present severe sensory problems
- present poor behavior during intervention
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 |
|---|---|---|
| OTHIGOccupational Therapy Handwriting Intervention Guideline | Other | OTHIG |
Primary outcome
The Print Tool
Time frame: 2 weeks
Handwriting assessment
1 secondary outcome
Test of Visual Perceptual Skills-4
Time frame: 2 weeks
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 9 Nov 2022.
- Individual participant dataSharing planned: Yes. All data collected will be shared among researchers
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.
Masne Kadar study director
Faculty of Health Sciences, UKM
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OTHIG in people with Difficulty Writing, run by National University of Malaysia at 4 sites in Malaysia.
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 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Malaysia. 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?
The Print Tool (time frame: 2 weeks). 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 9 Nov 2022.