Telematic Support in Early Intervention on Infants At Risk of Neurodevelopmental Delays

NCT ID: NCT06608576

Last Updated: 2024-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2025-07-31

Brief Summary

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The purpose of this study is to evaluate the effects of early intervention support sessions via video conferencing as an adjuvant option to motor development on infants at risk of neurodevelopmental delays or disorders.

Detailed Description

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The parents will be informed about the procedure and will be given a written informed consent in order to participate in the study. Then, the families will be randomized into one of two groups: standard treatment or telematic support. Both treatments in a 2-month period.

Conditions

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High-risk Infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Treatment

participants will receive face-to-face early intervention treatment on physical therapy area once a month for two months.

Group Type ACTIVE_COMPARATOR

Face-to-face standard treatment

Intervention Type OTHER

Individualized early intervention treatment on physical therapy area as usual in the early intervention facilities once a month for two months. Instructions will be given to the parents for follow-up at home to stimulate the baby's motor development until next face-to-face session.

Telematic Support

Participants will receive weekly telematic early intervention sessions at home via video conferencing for two months.

Group Type EXPERIMENTAL

Telematic Support

Intervention Type OTHER

The physiotherapist in charge of the telematic sessions will review and guide in real time through WhatsApp platform, the performance and active participation of the parents in the therapeutic activities being asked to follow-up at home in the face-to-face appointment, correcting, as necessary.

Interventions

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Face-to-face standard treatment

Individualized early intervention treatment on physical therapy area as usual in the early intervention facilities once a month for two months. Instructions will be given to the parents for follow-up at home to stimulate the baby's motor development until next face-to-face session.

Intervention Type OTHER

Telematic Support

The physiotherapist in charge of the telematic sessions will review and guide in real time through WhatsApp platform, the performance and active participation of the parents in the therapeutic activities being asked to follow-up at home in the face-to-face appointment, correcting, as necessary.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Minor infants with a chronological or corrected age of 3 to 12 months and their parents attending physical therapy early intervention protocol at the Neuropediatrics and Neurodevelopment Unit of San Cecilio University Hospital in Granada.
* At risk of neurodevelopmental delays or disorders.
* Whose family has a cell phone with WhatsApp Application installed and internet to be able to carry out the telematic tests.

Exclusion Criteria

* Independent walking children.
* Minor infants with diagnosis of neuromotor injury, visual and auditory sensory disorders or congenital anomalies.
* Infants with orthoses and/or prostheses.
* Children with health complications that enable the child's participation in the study.
* Not spanish-speaking parents.
Minimum Eligible Age

3 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario San Cecilio de Granada

UNKNOWN

Sponsor Role collaborator

Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Marie Carmen Valenza

PT, PhD, Professor at University of Granada

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario San Cecilio de Granada

Granada, Granada, Spain

Site Status

Countries

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Spain

Other Identifiers

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BBL-ATPO-2023

Identifier Type: -

Identifier Source: org_study_id

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