Skip to content

Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Children

Evaluating the Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Handwriting Skills for Children: A Protocol for Clustered-Randomised Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05217394
Enrollment
42
Registered
2022-02-01
Start date
2021-10-01
Completion date
2022-02-28
Last updated
2022-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficulty Writing

Keywords

handwriting, intervention, effectiveness, children, study protocol, clustered randomized controlled trial

Brief 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 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.

Interventions

OTHEROTHIG

Occupational Therapy Handwriting Intervention Guideline

Sponsors

Ministry of Education, Malaysia
CollaboratorOTHER_GOV
National University of Malaysia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
5 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

* age between five and nine years * engaged in OTs intervention either in an individual or group session.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
The Print Tool2 weeksHandwriting assessment

Secondary

MeasureTime frameDescription
Test of Visual Perceptual Skills-42 weeksVisual perceptual skills assessment

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026