The Effectiveness of Telehealth-Based Family-Centered Early Intervention

July 2, 2025 updated by: Taipei Medical University Shuang Ho Hospital

The Effectiveness of Telehealth-Based Family-Centered Early Intervention: Enhancing Sensory Inputs Activities on Vision and Posture-Movement Performance

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Past literature supports that digital media can be used as a medium to provide continuous interventional home-based occupational therapy for children who cannot receive physical therapy, and has the opportunity to guide the intervention through caregivers (Marino et al., 2020), using different visual and vestibular senses. For intervention factors, a home-based teaching model is designed to meet the needs of high-frequency supervision and feedback established by habits. It can respond appropriately and immediately to difficulties and adjust settings. In addition to providing timely assistance, individual consultations can also be provided on the online platform. , based on the capabilities of individual families or caregivers, as well as the child's own temperament and abilities, we provide exclusive technical advice to minimize difficulties and make the use of strategies more successful to help establish good home activities. Through the remote home teaching model, children's execution can be increased, including action planning, bilateral coordination, vestibular processing, visual perception, visual-motor integration and eye movement, thereby increasing the improvement of children's visual perception, posture and movement ( Božanić Urbančič et al., 2023; Wiener-Vacher et al., 2013; Yılmaz & Önal, 2021). For children who receive early treatment, caregivers often fail to provide ideal guidance despite intentional guidance. They are unable to provide appropriate home therapy activities according to the children's abilities and needs, and they also deviate from the games that children should participate in during their development. Therefore, through professional and standardized intervention models, subtle changes and learning in daily life are established in this way, promoting the quality of their visual movements and increasing learning performance.

In the clinical practice of early childhood education in our hospital, there is a lack of home treatment programs for early childhood education. This study intends to use the specific model of "1001 Children's Treatment Activities" as the basis for intervention in behavior change, combined with the participation of parents and children in games, to establish the basis for children's effective treatment. Good home activities and execution can improve children's visual perception, posture and movements, thereby improving learning performance.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei City, Taiwan, 235
        • Taipei Medical University Shuang Ho Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • (1) Children currently receiving early treatment; (2) Children with caregivers who need to establish a home treatment plan; (3) Children who can cooperate with the trial process and complete homework at home, and have completed at least 5/6 of the training; (4) There is an Internet connection;

Exclusion Criteria:

  • (1) Children's medical records show a diagnosis of central nervous system injury (such as cerebral palsy, brain trauma, epilepsy, cortical blindness), rare disease diagnosis (such as William's disease, Down syndrome); (2) Children under 3 years old , 7 years old and above; (3) The caregiver cannot communicate in Chinese.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telehealth group
An online video course for 6 weeks. The therapist will provide online video courses 3-5 times a week and record the implementation on the online platform every week. The course includes action plans, two Lateral integration/cross-midline, vestibular system, visual perception, opto-motor integration, eye movements, core strength activities and balance ability, etc.
Behavioral: Telehealth home activity
Several course activities with diverse sensory modalities are provided a week. Caregivers or caretakers need to help children participate in the course content and implement relevant suggestions at least 3-5 times a week for six weeks. The research will be conducted on an online platform. Course announcements, reminders and confirmation of work execution, through caregivers' feedback records, urge caregivers to engage in parent-child games related to sensory integration and integrated into life at home. Such high-frequency, short-term sensory activities will be adapted to the equipment available at home. It will mainly focus on movement planning, bilateral integration/crossing the midline, vestibular system , visual perception, visual-motor integration, eye movements, core strength activities and Activities focused on balance ability.
No Intervention: Waiting group
The "waiting group" was provided with an explanation of the objectives of the course. After the objectives of the study were explained in the first course, they waited for 6 weeks before receiving remote intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's sensory integration function assessment scale (preschool version)
Time Frame: before and after the intervention, study completion, an average of 6 weeks
In order to diagnose children with abnormal sensory integration in Taiwan, it covers seven dimensions of disorders and the phenomenon of sensory unintegration, with a total of 98 questions: posture and movement, integrated movement sequence on both sides, sensory discrimination, sensory adjustment, sensory search, and attention. and activity level, emotional/behavioral reactions, using a five-point scale. The higher the score, the worse the sensory integration, that is, the more obvious the disorder characteristics are. The test-retest reliability of each subscale is between .82 and .94; internal Consistency reliability ranges from .80 to .94
before and after the intervention, study completion, an average of 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Developmental Test of Visual Perception (DTVP-2)
Time Frame: before and after the intervention, study completion, an average of 6 weeks
A paper-and-pencil test that assesses the visual perception and visual movement integration abilities of children aged 4 to 12 years and 11 months, including hand-eye coordination, spatial position, imitation, subject-background distinction, spatial relationship, visual gestalt, optomotor speed, and shape constancy. Internal consistency>0.7, reliability and validity 0.78-0.91
before and after the intervention, study completion, an average of 6 weeks
Movement Assessment Battery for Children for Children, Second Edition ( MABC-2)
Time Frame: before and after the intervention, study completion, an average of 6 weeks
The age of the test is 3-16 years and 11 months. It evaluates the ability of hand dexterity, aiming and receiving objects, and balance. It uses the upper limb movement coordination subtest. It has good reliability and validity, and internal consistency (Internal consistency) α =0.90, test-retest reliability (Test-retest reliability) is ICC= 0.97, minimal detectable change (MDC) is 0.28 points, and minimal important difference (MID) is 2.36 to 2.50
before and after the intervention, study completion, an average of 6 weeks
the number of adverse reactions and side effects
Time Frame: After the intervention, study completion, an average of 6 weeks
After the intervention, ask whether there are any adverse reactions or side effects, such as aches, pains, injuries, etc., and record the number of occurrences in the case record form
After the intervention, study completion, an average of 6 weeks
Course satisfaction questionnaire
Time Frame: After the intervention, study completion, an average of 6 weeks
A self-made questionnaire based on the course content has a total of 12 questions, using a 5-point scale to collect data on caregivers' acceptance of the course, implementation effectiveness, and feedback on course implementation and changes in children.
After the intervention, study completion, an average of 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University Shuang Ho Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

July 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

September 22, 2024

First Submitted That Met QC Criteria

September 25, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Estimated)

July 8, 2025

Last Update Submitted That Met QC Criteria

July 2, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TMU-JIRB N202407062
  • 113HCP-04 (Other Grant/Funding Number: Shuang Ho Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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