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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06197035
Other study ID # USeville-EPINTO
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 10, 2024
Est. completion date October 20, 2024

Study information

Verified date March 2024
Source University of Seville
Contact Elena Pinero-Pinto, PhD
Phone +34655108763
Email epinero@us.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date October 20, 2024
Est. primary completion date October 20, 2024
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Months
Eligibility Inclusion Criteria: - Babies with Down syndrome - Families involved in Pediatric Physical Therapy Exclusion Criteria: - Other associated developmental disorders - To not speak Spanish - Do not sign informed consent

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain University of Seville Sevilla

Sponsors (1)

Lead Sponsor Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Motor Development INFANT MOTOR PROFILE Results achieved between the 10% and 90% percentiles indicate adequate motor development. Results between the 5% and 10% percentiles indicate a risk for delays or problems in gross motor development. 3-6-18 months.
Secondary Family empowerment Family Empowerment Scale
There are 28 items to be answered by the family with these options:
1= Strongly Agree' 2= Agree' 3= Disagree' 4= Strongly Disagree. The higher the score, the greater the empowerment.
3-6-18 months
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