Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Prosthetics in Children With Upper Limb Deficiency (EARLIMB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04851600
Recruitment Status : Not yet recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Limb Deficiencies Device: prosthesis

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adaptative Motor Behavior of Children With Unilateral Upper Limb Deficiency After Early Prosthetics.
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Vineland Adaptive Behavior Scales version II Motor skills Domain score Motor skills Domain score [ Time Frame: at 24 months old ]

Secondary Outcome Measures :
  1. Assisting Hand Assessment [ Time Frame: at 3 years old ]
  2. Communication Domain Score [ Time Frame: at 9 months old , at 24 months old ]
  3. Daily living skills Domain Score at 9 and 24 months old [ Time Frame: at 9 months old , at 24 months old, at 3 years old ]
  4. Socialization Domain score [ Time Frame: at 9 months old , at 24 months old, at 3 years old ]
  5. Motor skills Domain score [ Time Frame: at 9 months old ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Month to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Child with unilateral upper limb agenesis
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.
    • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851600


Contacts
Layout table for location contacts
Contact: Alice TAQUET, MD 03 28 80 07 70 ext +33 alice.taquet@marcsautelet.com

Locations
Layout table for location information
France
Ssr Pediatrique Marc Sautelet
Villeneuve-d'Ascq, France
Contact    0328800770      
Sponsors and Collaborators
University Hospital, Lille
Investigators
Layout table for investigator information
Principal Investigator: Alice TAQUET, MD University Hospital, Lille
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04851600    
Other Study ID Numbers: 2020_24
2021-A00108-33 ( Other Identifier: ID-RCB number,ANSM )
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Unilateral congenital upper extremity deficiency
Early development
Motor skills
Rehabilitation of amputees
 Upper extremity deficiency
Upper limb prosthesis
Adaptative behavior