NCT06654583

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

October 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2024

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2024

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

October 22, 2024

Last Update Submit

October 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 Months

Study Arms (2)

Interactive Play Mat

EXPERIMENTAL
Behavioral: Interactive Play Mat

Conventional Physical Therapy

EXPERIMENTAL
Behavioral: Conventional Physical Therapy

Interventions

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.

Interactive Play Mat

Stretching and Strengthening exercises

Conventional Physical Therapy

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Delayed Milestones, 2-5 Years of age

You may not qualify if:

  • Spina Bifida, Hydrocephalus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 22, 2024

First Posted

October 23, 2024

Study Start

October 1, 2023

Primary Completion

June 1, 2024

Study Completion

November 15, 2024

Last Updated

October 23, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations