NCT07331675

Brief Summary

This study aims to address the effects of a Marble Play on the handgrip strength and handwriting skills of primary school children, providing empirical evidence for a cost-effective and culturally relevant therapeutic tool. This study will be a randomized controlled trial. A total of 46 children from Grades 1-3 will be recruited via convenience sampling and randomly assigned to either an experimental group (n=23) or a control group (n=23).The experimental group will participate in one-on-one sessions of Marble Play game with .The control group will continue with their regular free play activities. The primary assessment tools will be the Evaluation Tool of Children's Handwriting (ETCH) to measure writing legibility and speed, and a hand-held dynamometer to measure hand grip strength.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Dec 2025Aug 2026

Study Start

First participant enrolled

December 22, 2025

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2026

Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

December 29, 2025

Last Update Submit

December 29, 2025

Conditions

Keywords

DynamometerHand writing skillsHand grip strength

Outcome Measures

Primary Outcomes (2)

  • Hand Grip Strength

    Hand grip strength will be measured by dynamometer

    Baseline and after 6 weeks

  • handwriting skills

    handwriting skills will be measured by ECTH. ECTH scoring refers to the Evaluation Tool of Children's Handwriting (ECTH), a criterion-referenced assessment for grades 1-6, scored by occupational therapists and educators to evaluate manuscript/cursive writing speed and legibility (letter/word formation, size, spacing, alignment) through specific tasks like copying, dictation, and sentence composition, yielding scores for each task and overall legibility percentages, with established cutoffs (e.g., Total Letter \<90%, Total Word \<85%) indicating dysfunction.

    Baseline and after 6 weeks

Study Arms (2)

Marble play group

EXPERIMENTAL

The experimental group will participate in one-on-one sessions of Marble Play game with progressive difficulty levels, designed to enhance fine motor control, handgrip and handwriting skills.

Other: Marble play game

Free play

OTHER

The control group will continue with their regular free play activities.

Other: Free Play

Interventions

Participants have to be sure to play in playground, as we will used natural ground floor. A small circle will be dig. A straight line will be marked 40 cm away from the edge of the circle. At the beginning of game, the researcher will place 10 target marbles in the circle. The participant will be given a marble.

Marble play group

The control group (n=38) will continues regular playing activities except Marble play.

Free play

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children enrolled in Grade 1-3 (typically aged 6-9 years)
  • Children with normal cognitive development, as assessed by school records or teacher reports
  • Students with average or below average handwriting fluency (based on teacher observation or pre-test).
  • Parental or guardian consent obtained for participation.
  • Regular school attendance and ability to participate in intervention sessions.

You may not qualify if:

  • Children with significant visual or motor impairments that may affect fine motor coordination.
  • Participants with a known history of dust allergy or diagnosed allergic rhinitis triggered by dust exposure will be excluded.
  • Individuals with a current or recent (within the last 6 months) fracture of any upper, wrist, or hand) will be excluded.
  • Students with a history of behavioral issues that would prevent consistent participation in structured play.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aamna Hassan

Lahore, Punjab Province, 5400, Pakistan

Location

Related Publications (3)

  • Hendrickx S. The adolescent and adult neuro-diversity handbook: Asperger's syndrome, ADHD, dyslexia, dyspraxia, and related conditions: Jessica Kingsley Publishers; 2010.

    BACKGROUND
  • Davis RD, Braun EM. The Gift of Learning: Proven New Methods for Correcting ADD, Math & Handwriting Problems: Penguin; 2003.

    BACKGROUND
  • Engel-Yeger B, Nagauker-Yanuv L, Rosenblum S. Handwriting performance, self-reports, and perceived self-efficacy among children with dysgraphia. Am J Occup Ther. 2009 Mar-Apr;63(2):182-92. doi: 10.5014/ajot.63.2.182.

    PMID: 19432056BACKGROUND

Study Officials

  • Aamna Hassan, MS

    Riphah International University, Lahore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 12, 2026

Study Start

December 22, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 20, 2026

Last Updated

January 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations