Clinical Trial

The Effectiveness of Telehealth-Based Family-Centered Early Intervention

Active, Not Recruiting
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Record status
This record was last updated July 8, 2025 (before its estimated July 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Background: Children with developmental delays or sensory processing disorders (SPD) face challenges in processing and integrating sensory information from their environment, which can lead to behavioral, learning, and social issues. Visual-vestibular stimulation activities target fundamental abilities such as balance, coordination, and sensory processing, which are crucial for many developmental areas. Past literature supports the use of digital media as a medium to provide ongoing home-based occupational therapy interventions for children who are unable to receive in-person treatment, with opportunities for caregiver-guided interventions. Therefore, this project is designed based on the \"1001 Children\'s Therapy Activities\" model as the foundation for behavioral intervention, combining parent and child participation in play to establish effective home activities and execution, aiming to enhance children\'s visual perception and posture-movement performance, thereby improving learning outcomes. Objective: To investigate the impact of a \"Telehealth Visual and Vestibular Home Program\" that integrates parent and child activity participation on children\'s visual perceptual performance and posture-movement effects. Method: Caregivers of children attending early intervention clinics at a teaching hospital in northern Taiwan are recruited and randomly assigned to either a remote group (N=30) or a waitlist group (N=30). The remote group receives a 6-week visual and vestibular home course; the waitlist group will participate after a 6-week. Assessments using the Developmental Test of Visual Perception (DTVP-2), the Movement Assessment Battery for Children, Second Edition (MABC-2), and a course satisfaction questionnaire are conducted before and after the intervention. Data Analysis: Basic data are presented using descriptive statistics, and t tests are used to compare pre- and post-training assessment mean values. Statistical analysis is performed using SPSS 26.0, with a significance level set at Alpha\<0.05.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-25.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-07-02
Trial Details
NCT Number NCT06615895
Lead Sponsor Taipei Medical University Shuang Ho Hospital
Conditions Children Receiving Early Intervention, Visual Perception Performance, Effects of Posture and Movement
Enrollment 60 participants
Start Date 2024-12-01
Primary Completion 2025-07-31 (estimated)
Study Completion 2025-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-07-08