Early Support and Physiotherapy for Children and Their Motor Skills

Cerebral Palsy Clinical Trial

— App-eMot-Quali  

Official title:

Identification of the Needs and Difficulties Associated With the Perceptual-motor Management of Infants at High Risk of Cerebral Palsy During the First 24 Months Following Neonatal Hospitalization. Qualitative Study Among Parents and Health Professionals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04523441
• Other study ID #: KRUMM APPARA 2019
• Status: Completed
• Start date: October 5, 2020
• Est. completion date: January 5, 2021

Study information

• Verified date: September 2021
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The App-eMot-Quali project proposed here is the first phase in the implementation of a care pathway supported by a digital tool. It consists of a qualitative study allowing individual interviews to be conducted with parents of infants at high risk of cerebral palsy and health professionals in order to identify and precisely describe the needs and difficulties present during the child's rehabilitative care during the first months of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 5, 2021
• Est. primary completion date: January 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. For the parents:

Parents of children under 24 months of age at high risk of cerebral palsy who have given their oral consent.

Children at high risk of cerebral palsy are defined as :

• Premature children = 31 WG + 6 days or birth weight less than 1000g.

• Children who have had a stroke or stage 2 or 3 hypoxia-ischemia according to the Sarnat classification.

The selection of parents may be retrospective with less than 24 months since hospital discharge.

2. For the health professionals:

Physiotherapists, psychomotricians, psychologists and doctors involved in the care of children at high risk of cerebral palsy.

Exclusion Criteria:

• A person who is physically or cognitively unable to participate in a one-on-one interview or who does not have a sufficient command of the French language.

• Parents aged <18 years

• Parents in protective custody

• Parents of children with major orthopedic or traumatic disorders unrelated to the high risk of cerebral palsy.

• Parents of a child with a genetic disease.

Related Conditions & MeSH terms

• Cerebral Palsy
• Infant
• Neonatal

Intervention

Other:
• Focus group
Holding of a focus group by a sociologist
• Semi-directive interview
Conducting a semi-directive interview by a sociologist after discharge from hospital

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Typology and categorization of the needs and difficulties encountered by the parents.	collected through semi-directive individual interviews with parents	Through study completion an average of 21 months