Early Prosthetics in Children With Upper Limb Deficiency

Limb Deficiencies Clinical Trial

— EARLIMB  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04851600
• Other study ID #: 2020_24
• Secondary ID: 2021-A00108-33
• Status: Not yet recruiting
• Start date: May 2021
• Est. completion date: May 2026

Study information

• Verified date: February 2021
• Source: University Hospital, Lille
• Contact: Alice TAQUET, MD
• Phone: 03 28 80 07 70
• Email: alice.taquet[@]marcsautelet.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 3 Months

Eligibility

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

Related Conditions & MeSH terms

• Limb Deficiencies

Intervention

Device:
• prosthesis
Casting and delivery of a cosmetic upper limb prosthesis at 3-4 months old of age.

Locations

Country	Name	City	State
France	Ssr Pediatrique Marc Sautelet	Villeneuve-d'Ascq

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vineland Adaptive Behavior Scales version II Motor skills Domain score Motor skills Domain score		at 24 months old
Secondary	Assisting Hand Assessment		at 3 years old
Secondary	Communication Domain Score		at 9 months old , at 24 months old
Secondary	Daily living skills Domain Score at 9 and 24 months old		at 9 months old , at 24 months old, at 3 years old
Secondary	Socialization Domain score		at 9 months old , at 24 months old, at 3 years old
Secondary	Motor skills Domain score		at 9 months old