Pediatric ALLNCT06654583
Effectiveness of Developed Interactive Play Mat In Pediatric Physical Therapy
A study testing Interactive Play Mat and Conventional Physical Therapy in people with Pediatric ALL, run by Superior University at 1 site in Pakistan.
Trial summary
The proposed study seeks to innovate by harnessing the potential of an interactive play mat, integrating haptic feedback and captivating sensory stimuli, to facilitate and expedite the motor skill development process in children with delayed milestones. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Pediatric ALL
- What is being tested?
- Interactive Play Mat and Conventional Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2023to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Delayed Milestones, 2-5 Years of age
Who cannot join
- Spina Bifida, Hydrocephalus
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University
Lahore, Punjab Province
About this study
The proposed study seeks to innovate by harnessing the potential of an interactive play mat, integrating haptic feedback and captivating sensory stimuli, to facilitate and expedite the motor skill development process in children with delayed milestones.
Read the detailed description
This research endeavors to contribute substantively to the field of pediatric therapy by providing an engaging, effective, and accessible intervention that aligns with the specific needs of this vulnerable population.
- Conditions
- Pediatric ALL
- Being tested
- Interactive Play Mat, Conventional Physical Therapy
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Play MatBehavioural
Use of developed interactive play mat that utilizes haptic feedback vibrations to assist children with delayed milestones in achieving Gross Motor Skills. The play mat aims to provide a therapeutic and engaging experience by incorporating visuals, sounds, and lights to encourage movement that might otherwise be challenging for these children.
Conventional Physical TherapyBehavioural
Stretching and Strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Interactive Play Mat | Experimental | Not described Receives: Behavioral: Interactive Play Mat |
| Conventional Physical Therapy | Experimental | Not described Receives: Behavioral: Conventional Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross motor function classification system
GMFCS looks at movements like sitting and walking, and it provides a a clear description of someone's current motor function, and an idea of what equipment or mobility aids a child or adult may need in the future, like crutches, a walker, or a wheelchair. GMFCS Level I Can walk indoors and outdoors and climb stairs without using their hands for support.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Oct 2023
- Primary completion1 Jun 2024
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- More trials run by Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654583
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/743
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Developed Interactive Play Mat In Pediatric Physical Therapy
- ClinicalTrials.gov ID
- NCT06654583
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/743
- Conditions
- Pediatric ALL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 23 Oct 2024 (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.
The proposed study seeks to innovate by harnessing the potential of an interactive play mat, integrating haptic feedback and captivating sensory stimuli, to facilitate and expedite the motor skill development process in children with delayed milestones.
Detailed description
This research endeavors to contribute substantively to the field of pediatric therapy by providing an engaging, effective, and accessible intervention that aligns with the specific needs of this vulnerable population.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Play Mat | Experimental | Behavioral: Interactive Play Mat |
| Conventional Physical Therapy | Experimental | Behavioral: Conventional Physical Therapy |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Delayed Milestones, 2-5 Years of age
Key exclusion criteria (1 listed)
- Spina Bifida, Hydrocephalus
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 |
|---|---|---|
| Interactive Play MatUse of developed interactive play mat that utilizes haptic feedback vibrations to assist children with delayed milestones in achieving Gross Motor Skills. The play mat aims to provide a therapeutic and engaging experience by incorporating visuals, sounds, and lights to encourage movement that might otherwise be challenging for these children. | Behavioural | Interactive Play Mat |
| Conventional Physical TherapyStretching and Strengthening exercises | Behavioural | Conventional Physical Therapy |
Primary outcome
Gross motor function classification system
Time frame: 12 Months
GMFCS looks at movements like sitting and walking, and it provides a a clear description of someone's current motor function, and an idea of what equipment or mobility aids a child or adult may need in the future, like crutches, a walker, or a wheelchair. GMFCS Level I Can walk indoors and outdoors and climb stairs without using their hands for support.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Play Mat and Conventional Physical Therapy in people with Pediatric ALL, run by Superior University at 1 site in Pakistan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross motor function classification system (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2024.