Early Prosthetics in Children With Upper Limb Deficiency

Not yet recruiting

• Conditions: Limb Deficiencies
• Interventions: Device: prosthesis

• Registration Number: NCT04851600
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-04-14
• Study First Submitted QC: 2021-04-14
• Last Update Submitted: 2021-04-14
• Study First Posted: 2021-04-20
• Last Update Posted: 2021-04-20
• Study Start: 2021-05
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early introduction	prosthesis	Casting and delivery of a cosmetic upper limb prosthesis at 3-4 months old of age.

Primary Outcome Measures

Name	Time	Method
Vineland Adaptive Behavior Scales version II Motor skills Domain score Motor skills Domain score	at 24 months old

Secondary Outcome Measures

Name	Time	Method
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
Communication Domain Score	at 9 months old , at 24 months old
Assisting Hand Assessment	at 3 years old

Trial Locations

Locations (1)

Ssr Pediatrique Marc Sautelet; 🇫🇷 Villeneuve-d'Ascq, France