Down Syndrome, Family, Physical Disability
Conditions
Brief 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.
Interventions
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.
PROCEDUREStandard Physiotherapy
Pediatric physiotherapy techniques aimed at improving the development of the baby and young child from manual therapy tools, or baby management.
Sponsors
University of Seville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Two intervention groups, a group with COPCA intervention and a group with standard physiotherapy
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor Development | 3-6-18 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Family empowerment | 3-6-18 months | 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. |
Countries
Spain
Contacts
Primary ContactElena Pinero-Pinto, PhD
Outcome results
None listed