NCT06943248

Brief Summary

This study compares Image-Sand Play Therapy and Tabletop Training with Weighted Cuffs for improving Visual-Motor Integration (VMI) in children with autism. A 12-week randomized controlled trial will be conducted at Tanzeem-ul-Nisan, Faisalabad. Beery VMI will assess outcomes. Data will be analyzed using SPSS-23. Non-probability conventional sampling will be used. Sessions occur twice weekly.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

April 17, 2025

Last Update Submit

April 17, 2025

Conditions

Keywords

Sand play, Table-top training, Beery VMI

Outcome Measures

Primary Outcomes (2)

  • Berry Visual Motor Integration

    The Beery-Buktenica Developmental Test of Visual-Motor Integration (Beery VMI) is the gold standard for identifying difficulties in the coordination of visual and motor skills in adults and children. The Beery VMI based on the construction of test items, the Beery VMI has strong construct validity and strong predictive validity for academic outcomes. Visual motor Coordination takes around 10-15 min. The task is completed in three minutes. Excellent test-retest reliability (0.84-0.88)(16) Interrater reliability of (0.90 0.98). Internal consistency (0.81-0.82)

    Baseline,4th week, 8th week and 12th week

  • Nine Hole Peg Board

    The Nine Hole Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses(18, 19). Table (wooden or plastic): with 9 holes (diameter 10 mm, depth 15 mm) separated by 32 mm or 50 mm(20). Stick container: a square box (100 x 100 x 10 mm) separate from the boards or a shallow round container on top of the board. 9 pins (diameter 7 mm, length 32 mm)(21). Stopwatch Instruct the patient to remove the needles one by one from the container and insert them into the holes in the plate as quickly as possible, using only their hands. Ask the patient to remove the needles one by one from the holes and return them to the container. Excellent Test-retest reliability (ICC = 0.85). Excellent interrater reliability for the right hand (r = 0.984) and the left hand (r = 0.993) (22).

    Baseline, 4th week ,8th week and 12th week

Study Arms (2)

Image-Sand Play Therapy

EXPERIMENTAL

Group A will perform Image-Sand Play Therapy Group had 12 week the one to one intervention provided once a week 30 min in each.

Other: Image-Sand Play Therapy

Table Top Training Program with Weighted Cuff

ACTIVE COMPARATOR

Table Top training Program Duration: 12 week Patient perform twice a week each item 5 min with 1 min preparation between task

Other: Table Top Training Program with Weighted Cuff

Interventions

Over the course of seven sessions, the child initially engaged in chaotic sandbox play, showing difficulty in altering or organizing his scenes. By the fourth session, he began experimenting with different symbols, including familiar TV characters. From the fifth session onward, his play gained structure, evolving into strategic battle scenarios involving animals, loggers, and castles. By the seventh session, hero figures emerged, and the therapist noted improved classroom behavior and cooperation, though social challenges with peers remained.

Image-Sand Play Therapy

Task include: Stacking cones Lift a cone with one hand and stack it on top of a fixed cone. (The difficulty level was controlled by using resistance bands of varying weights or instructing patients to sit or stand while performing the task.) Task Therapy Program Stacking 3 × 3 cm blocks Pick up blocks one at a time by using one hand and stack them. (The difficulty level was controlled by using resistance bands of varying weights.) Tailwind Use both hands to push the handles of an instrument up and down to the sounds of a metronome. (The difficulty level was controlled by varying the angle.) Pinch exerciser Take a pinch pin and put it on a rod. (The difficulty level was controlled by varying the resistance of the pinch pin (5 grades) and the diameter of the rod (3 grades).) O'Connor Tweezer Dexterity Test Pick up a pin (2.5 cm long) and put it in a 15 mm hole. (The difficulty level was controlled by using different tweezers.)

Table Top Training Program with Weighted Cuff

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 5-8 yrs
  • A diagnosed by Autism
  • Guardian of child patients signed the informed consent
  • Both gender male and female

You may not qualify if:

  • Complication of serious medical disease
  • Children and parents who cannot comply with the research
  • Surgical procedures performed in the year prior to the study
  • Poor medical conditions preventing participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Patil O, Kaple M. Sensory Processing Differences in Individuals With Autism Spectrum Disorder: A Narrative Review of Underlying Mechanisms and Sensory-Based Interventions. Cureus. 2023 Oct 31;15(10):e48020. doi: 10.7759/cureus.48020. eCollection 2023 Oct.

    PMID: 38034138BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Hamna Faisal, MA-PPT

    Rihah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Asif Javed, MS-PPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be separate treatment protocol and possible efforts will be put to mask the both group about treatment
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A Randomized clinical trail performed, in which 30 children autism spectrum disorder with the age of 5-8 years will be taken after screening and meeting inclusion criteria. Children will be divided in two groups. Group A will perform Image-Sand Play Therapy Group had 12 week Image-Sand Play therapy, the one to one intervention provided once a week 30 min in each. Group B Table Top Training Program with Weighted Cuff Table Top training Program Duration: 12 week Patient perform each item 5 min with 1 min preparation between task . Pre values were taken at 1st week and then after 6th week mid values of interventions will be taken and post values of intervention will be taken after 12th week to measure the effect of both therapies .
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2025

First Posted

April 24, 2025

Study Start

April 15, 2025

Primary Completion

June 15, 2025

Study Completion

August 15, 2025

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share