Adaptative Motor Behavior of Children With Unilateral Upper Limb Deficiency After Early Prosthetics.

University Hospital, Lille1 site in 1 country30 target enrollmentMay 2021

ConditionsLimb Deficiencies

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Limb Deficiencies
Sponsor: University Hospital, Lille
Enrollment: 30
Locations: 1
Primary Endpoint: Vineland Adaptive Behavior Scales version II Motor skills Domain score Motor skills Domain score
Status: Not yet recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2021

End Date

May 2026

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Lille

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Vineland Adaptive Behavior Scales version II Motor skills Domain score Motor skills Domain score

Time Frame: at 24 months old

Secondary Outcomes

Communication Domain Score(at 9 months old , at 24 months old)
Assisting Hand Assessment(at 3 years old)
Daily living skills Domain Score at 9 and 24 months old(at 9 months old , at 24 months old, at 3 years old)
Motor skills Domain score(at 9 months old)
Socialization Domain score(at 9 months old , at 24 months old, at 3 years old)