Early Prosthetics in Children With Upper Limb Deficiency (EARLIMB)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Limb Deficiencies
• Intervention / Treatment: Device: prosthesis

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Alice TAQUET, MD; Phone Number: +33 03 28 80 07 70; Email: alice.taquet@marcsautelet.com

Study Locations

• France
  • Villeneuve-d'Ascq, France
    • SSR pédiatrique Marc Sautelet
    • Contact: Phone Number: 0328800770

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Child with unilateral upper limb agenesis

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early introduction; Casting and delivery of a cosmetic upper limb prosthesis at 3-4 months old of age.	Device: prosthesis; Casting and delivery of a cosmetic upper limb prosthesis at 3-4 months old of age.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vineland Adaptive Behavior Scales version II Motor skills Domain score Motor skills Domain score	at 24 months old

Secondary Outcome Measures

Outcome Measure	Time Frame
Assisting Hand Assessment	at 3 years old
Communication Domain Score	at 9 months old , at 24 months old
Daily living skills Domain Score at 9 and 24 months old	at 9 months old , at 24 months old, at 3 years old
Socialization Domain score	at 9 months old , at 24 months old, at 3 years old
Motor skills Domain score	at 9 months old

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Alice TAQUET, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): May 1, 2026
• Study Completion (Anticipated): May 1, 2026

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Motor skills; Early development; Unilateral congenital upper extremity deficiency; Rehabilitation of amputees; Upper extremity deficiency; Upper limb prosthesis; Adaptative behavior
• Other Study ID Numbers: 2020_24; 2021-A00108-33 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No