- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06943248
Sand Play vs. Cuff Training: Visual-Motor Skills in Autism
Effects of Image-Sand Play Therapy Versus Table Top Training Program With Weighted Cuffs on Visual Motor Integration in Children With Autism
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study compares the effectiveness of Image-Sand Play Therapy and Tabletop Training with Weighted Cuffs in improving Visual-Motor Integration (VMI) in children with autism.
Methods: A randomized controlled trial will be conducted with children diagnosed with autism from Tanzeem-ul-Nisan, Faisalabad. Participants will be randomly assigned to either intervention group. Both therapies will run for 12 weeks, with two sessions per week.
Image-Sand Play Therapy: Creative sand tray play guided by a therapist.
Tabletop Training: Structured tasks with weighted cuffs for proprioceptive input.
Assessment Tool: Beery VMI
Sampling: Non-probability conventional sampling
Data Analysis: SPSS version 23, using baseline, mid, and post-intervention scores to compare effectiveness.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MRAN AMJAD, PhD
- Phone Number: 033224390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed, MS-PPT
- Phone Number: 03224209422
- Email: a.javed@riphah.edu.pk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age 5-8 yrs
- A diagnosed by Autism
- Guardian of child patients signed the informed consent
- Both gender male and female
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Image-Sand Play Therapy
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.
|
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.
|
|
Active Comparator: Table Top Training Program with Weighted Cuff
Table Top training Program Duration: 12 week Patient perform twice a week each item 5 min with 1 min preparation between task
|
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.) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berry Visual Motor Integration
Time Frame: Baseline,4th week, 8th week and 12th week
|
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
Time Frame: Baseline, 4th week ,8th week and 12th week
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hamna Faisal, MA-PPT, Rihah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR/AHS/24/0750
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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