Early Support and Physiotherapy for Children and Their Motor Skills (App-eMot-Quali)

September 30, 2021 updated by: Centre Hospitalier Universitaire Dijon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

37

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21000
        • Chu Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Parents
man or woman
Other: Semi-directive interview
Conducting a semi-directive interview by a sociologist after discharge from hospital
Professionals
health professionals in charge of monitoring children
Other: Focus group
Holding of a focus group by a sociologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Typology and categorization of the needs and difficulties encountered by the parents.
Time Frame: Through study completion an average of 21 months
collected through semi-directive individual interviews with parents
Through study completion an average of 21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 5, 2020

Primary Completion (ACTUAL)

January 5, 2021

Study Completion (ACTUAL)

January 5, 2021

Study Registration Dates

First Submitted

August 19, 2020

First Submitted That Met QC Criteria

August 20, 2020

First Posted (ACTUAL)

August 21, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KRUMM APPARA 2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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