Early Prosthetics in Children With Upper Limb Deficiency (NCT04851600) | Clinical Trial Compass
UnknownNot Applicable
Early Prosthetics in Children With Upper Limb Deficiency
France30 participantsStarted 2021-05
Plain-language 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.
Who can participate
Age range
1 Month – 3 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Vineland Adaptive Behavior Scales version II Motor skills Domain score Motor skills Domain score