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The Coping With and Caring for Infants With Special Needs Intervention in Down Syndrome Infants

NCT06197035 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-01

No results posted yet for this study

Summary

The objective is to compare the impact of standard infant physical therapy and the family-centered program, Coping with and Caring for Infants with Special Needs (COPCA), on infants born with Down syndrome. This is a randomized controlled trial that will be carried out in the patients' homes and outpatient settings in Spain between January 2024 and March 2024. An evaluation battery will be used that includes child and family outcomes and video analysis of therapy sessions.

The Infant Motor profile will be the primary outcome instrument.

Conditions

  • Down Syndrome
  • Family
  • Physical Disability

Interventions

PROCEDURE

Coping With and Caring for Infants With Special Needs

The early intervention programme for infants and young children focuses on the active inclusion of the whole family. The coaching of parents is a central component. Parents learn how they can independently and optimally support their child's development as part of the child's everyday life. The programme was developed at the beginning of the 2000s in the Netherlands by child physiotherapist Tineke Dirks and professor of developmental neurology Mijna Hadders-Algra.

PROCEDURE

Standard Physiotherapy

Pediatric physiotherapy techniques aimed at improving the development of the baby and young child from manual therapy tools, or baby management.

Sponsors & Collaborators

  • University of Seville

    lead OTHER

Principal Investigators

  • Elena Pinero-Pinto, PhD · University of Seville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-10
Primary Completion
2024-10-20
Completion
2024-10-20

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06197035 on ClinicalTrials.gov