Autism Spectrum DisorderNCT06943248
Sand Play vs. Cuff Training: Visual-Motor Skills in Autism
A study testing Image-Sand Play Therapy and Table Top Training Program with Weighted Cuff in people with Autism Spectrum Disorder, run by Riphah International University.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Image-Sand Play Therapy and Table Top Training Program with Weighted Cuff
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 5-8 yrs
- A diagnosed by Autism
- Guardian of child patients signed the informed consent
- Both gender male and female
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Image-Sand Play Therapy Versus Table Top Training Program With Weighted Cuffs on Visual Motor Integration in Children With Autism
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Image-Sand Play Therapy, Table Top Training Program with Weighted Cuff
- Keywords
- Sand play, Table-top training, Beery VMI
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-Sand Play TherapyOther
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.
Table Top Training Program with Weighted CuffOther
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.)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Table Top Training Program with Weighted Cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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).
Measured: Baseline, 4th week ,8th week and 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 .
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hamna Faisal, MA-PPT, Principal investigator, Rihah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943248
- Sponsor's protocol ID
- REC/RCR/AHS/24/0750
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38034138
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Image-Sand Play Therapy Versus Table Top Training Program With Weighted Cuffs on Visual Motor Integration in Children With Autism
- ClinicalTrials.gov ID
- NCT06943248
- Acronym / sponsor ID
- REC/RCR/AHS/24/0750
- Conditions
- Autism Spectrum Disorder
- Keywords
- Sand play, Table-top training, Beery VMI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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 .
| Arm | Type | Receives |
|---|---|---|
| Image-Sand Play Therapy | Experimental | Other: Image-Sand Play TherapyGroup A will perform Image-Sand Play Therapy Group had 12 week the one to one intervention provided once a week 30 min in each. |
| Table Top Training Program with Weighted Cuff | Active comparator | Other: Table Top Training Program with Weighted CuffTable Top training Program Duration: 12 week Patient perform twice a week each item 5 min with 1 min preparation between task |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 5-8 yrs
Key exclusion criteria (4 listed)
- Complication of serious medical disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image-Sand Play TherapyOver 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. | Other | Image-Sand Play Therapy |
| Table Top Training Program with Weighted CuffTask 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.) | Other | Table Top Training Program with Weighted Cuff |
Primary outcome
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)
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Background: PubMed 38034138Patil 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hamna Faisal, MA-PPT principal investigator
Rihah International University
Questions about this trial
What is this clinical trial studying?
A study testing Image-Sand Play Therapy and Table Top Training Program with Weighted Cuff in people with Autism Spectrum Disorder, run by Riphah International University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MRAN AMJAD, PhD (033224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berry Visual Motor Integration (time frame: Baseline,4th week, 8th week and 12th week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06943248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.