Early Prosthetics in Children With Upper Limb Deficiency

NCT04851600 | Not Yet Recruiting

• 2 other identifiers: 2020_242021-A00108-33
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Limb Deficiencies

Keywords

Unilateral congenital upper extremity deficiency; Early development; Motor skills; Rehabilitation of amputees; Upper extremity deficiency; Upper limb prosthesis; Adaptative behavior

Outcome Measures

Primary Outcomes (1)

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

  at 24 months old

Secondary Outcomes (5)

• 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

Study Arms (1)

Early introduction

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

Device: prosthesis

Interventions

prosthesis DEVICE

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

Early introduction

Eligibility Criteria

• Age: 1 Month - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Child with unilateral upper limb agenesis

You may qualify if:

• 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

You may not qualify if:

• 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).
• Refusal of consent from one or both parents

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Ssr Pediatrique Marc Sautelet

Villeneuve-d'Ascq, France

Location

MeSH Terms

Interventions

Prostheses and Implants

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Alice TAQUET, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice TAQUET, MD

CONTACT

03 28 80 07 70; alice.taquet@marcsautelet.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 20, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 20, 2021

Record last verified: 2021-02

Locations

FR (1)