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Clinical Trials/NCT05217394
NCT05217394
Completed
Not Applicable

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

National University of Malaysia4 sites in 1 country42 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Difficulty Writing
Sponsor
National University of Malaysia
Enrollment
42
Locations
4
Primary Endpoint
The Print Tool
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
February 28, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National University of Malaysia
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

The Print Tool

Time Frame: 2 weeks

Handwriting assessment

Secondary Outcomes

  • Test of Visual Perceptual Skills-4(2 weeks)

Study Sites (4)

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