Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A00108-33 | Other Identifier | ID-RCB number,ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early introduction | Casting and delivery of a cosmetic upper limb prosthesis at 3-4 months old of age. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prosthesis | Device | Casting and delivery of a cosmetic upper limb prosthesis at 3-4 months old of age. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vineland Adaptive Behavior Scales version II Motor skills Domain score Motor skills Domain score | at 24 months old |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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
Not provided
Not provided
Child with unilateral upper limb agenesis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alice TAQUET, MD | Contact | 03 28 80 07 70 | +33 | alice.taquet@marcsautelet.com |
| Name | Affiliation | Role |
|---|---|---|
| Alice TAQUET, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ssr Pediatrique Marc Sautelet | Villeneuve-d'Ascq | France |
Not provided
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |