Limb DeficienciesEARLIMBNCT04851600
Early Prosthetics in Children With Upper Limb Deficiency
An observational study of Limb Deficiencies, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 month to 3 months
- Conditions the study is for
- Limb Deficiencies
- What is being tested?
- prosthesis
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- May 2021to May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: Child with unilateral upper limb agenesis
Who may be able to join
- 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
Who cannot join
- 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).
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Limb Deficiencies
- Being tested
- prosthesis
- Keywords
- Unilateral congenital upper extremity deficiency, Early development, Motor skills, Rehabilitation of amputees, Upper extremity deficiency, Upper limb prosthesis, Adaptative behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prosthesisDevice
Casting and delivery of a cosmetic upper limb prosthesis at 3-4 months old of age.
| Study group | Role | What they receive |
|---|---|---|
| Early introduction | Casting and delivery of a cosmetic upper limb prosthesis at 3-4 months old of age. Receives: Device: prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vineland Adaptive Behavior Scales version II Motor skills Domain score Motor skills Domain score
Measured: at 24 months old
Secondary outcomes (5)
Assisting Hand Assessment
Measured: at 3 years old
Communication Domain Score
Measured: at 9 months old , at 24 months old
Daily living skills Domain Score at 9 and 24 months old
Measured: at 9 months old , at 24 months old, at 3 years old
Socialization Domain score
Measured: at 9 months old , at 24 months old, at 3 years old
Motor skills Domain score
Measured: at 9 months old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study startMay 2021 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb DeficienciesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice TAQUET, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851600
- Sponsor's protocol ID
- 2020_24
- Other IDs
- 2021-A00108-33
- Acronym
- EARLIMB
- Status last verified
- Feb 2021
- First submitted
- 14 Apr 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptative Motor Behavior of Children With Unilateral Upper Limb Deficiency After Early Prosthetics.
- ClinicalTrials.gov ID
- NCT04851600
- Acronym / sponsor ID
- EARLIMB / 2020_24
- Conditions
- Limb Deficiencies
- Keywords
- Unilateral congenital upper extremity deficiency, Early development, Motor skills, Rehabilitation of amputees, Upper extremity deficiency, Upper limb prosthesis, Adaptative behavior
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early introduction | – | Device: prosthesisCasting and delivery of a cosmetic upper limb prosthesis at 3-4 months old of age. |
Who may qualify
- Ages
- 1 month to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Child with unilateral upper limb agenesis
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- Children with one or more high risk factors for neurodevelopmental disorders:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prosthesisCasting and delivery of a cosmetic upper limb prosthesis at 3-4 months old of age. | Device | Early introduction |
Primary outcome
Vineland Adaptive Behavior Scales version II Motor skills Domain score Motor skills Domain score
Time frame: at 24 months old
5 secondary outcomes
Assisting Hand Assessment
Time frame: at 3 years old
Communication Domain Score
Time frame: at 9 months old , at 24 months old
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
Socialization Domain score
Time frame: at 9 months old , at 24 months old, at 3 years old
Motor skills Domain score
Time frame: at 9 months old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alice TAQUET, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Limb Deficiencies, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alice TAQUET, MD (03 28 80 07 70 ext. +33, alice.taquet@marcsautelet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vineland Adaptive Behavior Scales version II Motor skills Domain score Motor skills Domain score (time frame: at 24 months old). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.