Clinical trial NCT04851600: Early Prosthetics in Children With Upper Limb Deficiency
Official title: Adaptative Motor Behavior of Children With Unilateral Upper Limb Deficiency After Early Prosthetics.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Limb Deficiencies
Keywords: Unilateral congenital upper extremity deficiency
Early development
Motor skills
Rehabilitation of amputees
Upper extremity deficiency
Upper limb prosthesis
Adaptative behavior
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Child with unilateral upper limb agenesis

Brief summary: For children with congenital upper limb deficiency, introduction of the prosthesis is guided by clinical experience rather than by Evidence Based Medicine.

This study will assess early development in children with upper limb deficiency according to age at the introduction of the prosthesis.

This study will give new keys in these specific prosthesis cares.


Eligibility criteria: Inclusion Criteria:

* Male or female child
* Aged from 1 month to 3 months and a half
* Placement of a prosthesis in a patient with isolated upper limb deficiency, type of congenital transverse unilateral amputation of the forearm segment
* Socially insured patient,
* Patient willing to comply with all study procedures and study duration
* Written informed consent from patient's legal guardians

Exclusion Criteria:

* Children with one or more high risk factors for neurodevelopmental disorders:

  * Very prematurity (\<32 weeks of amenorrhea \[SA\])
  * Premature infants \<37 WA with intrauterine growth retardation (IUGR) or low weight for gestational age (PAG) \<3rd percentile or \<- 2 SD for GA and sex according to national reference curves)
  * A presumed hypoxo-ischemic encephalopathy with an indication of therapeutic hypothermia
  * A perinatal arterial cerebrovascular accident (AVC) (diagnosed between the 20th week of fetal life and the 28th day of life including in premature newborns).
  * Cerebral growth anomalies: microcephaly with cranial perimeter \<- 2 SD at birth verified secondarily or macrocephaly\> + 3 SD for the term (persisting after a second measurement).
  * A family history of severe first-degree neurodevelopmental disorder (brother or sister or parent)
  * Symptomatic congenital cytomegalovirus infections and other infectious fetopathies: toxoplasmosis, Zika, rubella, etc.
  * Bacterial and viral herpetic meningoencephalitis
  * Complex congenital heart disease operated on: transposition of the large vessels; left ventricular hypoplastic syndrome.
  * Perinatal exposure to a major toxicant: certain antiepileptics (sodium valproate); severe exposure to alcohol and / or with signs of fetal disease.
  * Major, prolonged and repeated surgery (cardiac, cerebral, abdominal, thoracic).
* Exclusion of all deficiency forming part of a polymalformative, vascular syndrome (Poland syndrome), genetic cause ...
* Exclusion of all other forms of agenesis (bilateral, longitudinal, persistence of hand remains),
* Refusal of consent from one or both parents

Primary outcomes:
measure: Vineland Adaptive Behavior Scales version II Motor skills Domain score Motor skills Domain score
timeFrame: at 24 months old
Secondary outcomes:
measure: Assisting Hand Assessment
timeFrame: at 3 years old
measure: Communication Domain Score
timeFrame: at 9 months old , at 24 months old
measure: Daily living skills Domain Score at 9 and 24 months old
timeFrame: at 9 months old , at 24 months old, at 3 years old
measure: Socialization Domain score
timeFrame: at 9 months old , at 24 months old, at 3 years old
measure: Motor skills Domain score
timeFrame: at 9 months old
Other outcomes:
Locations:
city: Villeneuve-d'Ascq
country: France
facility: Ssr Pediatrique Marc Sautelet
Study officials:
affiliation: University Hospital, Lille
name: Alice TAQUET, MD
role: PRINCIPAL_INVESTIGATOR
References: