Early Support and Physiotherapy for Children and Their Motor Skills

NCT04523441 | Completed

• 1 other identifier: KRUMM APPARA 2019
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant; Cerebral Palsy; Neonatal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Parents

man or woman

Other: Semi-directive interview

Professionals

health professionals in charge of monitoring children

Other: Focus group

Interventions

Focus group OTHER

Holding of a focus group by a sociologist

Professionals

Semi-directive interview OTHER

Conducting a semi-directive interview by a sociologist after discharge from hospital

Parents

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parents of children under 24 months of age and health professionals working in the paediatric intensive care unit at the Dijon Bougogne University Hospital.

You may qualify if:

• 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.
• For the health professionals:
• Physiotherapists, psychomotricians, psychologists and doctors involved in the care of children at high risk of cerebral palsy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 21, 2020
• Study Start: October 5, 2020
• Primary Completion: January 5, 2021
• Study Completion: January 5, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

FR (1)