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Completed

NCT Number: NCT04523441

Early Support and Physiotherapy for Children and Their Motor Skills

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.

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Key information

Conditions

Infant Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Neonatal Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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.

Treatment and study plan

Focus Group

Other

Holding of a focus group by a sociologist

Semi-directive interview

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study 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

Acronym: App-eMot-Quali

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 21, 2020
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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