Effectiveness of the Occupational Therapy Handwriting Intervention Guideline on Children

NCT05217394 | Completed

• 1 other identifier: FRGS/1/2020/SSI0/UKM/03/2
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 4

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.

Conditions

Difficulty Writing

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The Print Tool

  Handwriting assessment

  2 weeks

Secondary Outcomes (1)

• Test of Visual Perceptual Skills-4

  2 weeks

Study Arms (2)

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

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.

Interventions

OTHIG OTHER

Occupational Therapy Handwriting Intervention Guideline

OTHIG

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Malaysia: lead
• Ministry of Education, Malaysia: collaborator

Study Sites (4)

Kiddie Care Centre

Jitra, Kedah, 06000, Malaysia

Location

Ryan Special Needs Rehabilitation Centre

Putrajaya, PU, 62150, Malaysia

Location

Excel Qhalif Playgroup Centre

Bangi, Selangor, Malaysia

Location

Kizzu Kids Centre

Shah Alam, Selangor, Malaysia

Location

Study Officials

• Masne Kadar

  Faculty of Health Sciences, UKM

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: February 1, 2022
• Study Start: October 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 28, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: October 2021 until September 2022
• Access Criteria: Study protocol will be shared with all researchers

Locations

MY (4)