Table 1.
Visits and study procedure
| Action | Visit 1 : 10 months of age (inclusion, medical and therapists) |
Visit 2:11 months of age (MRI) |
Visit 3:12 months of age (injection, medical follow-up l) |
Visit 4: D10 post-injection (medical follow-up) |
Visit 5:13 months of age (phone call) |
Visit 6: 14 months of age (phone call) |
Visit 7: 15 months of age (medical and therapists) |
Visit 8: 16 months of age (phone call) |
Visit 9: 17 months of age (phone call) |
Visit 10:18 months of age (MRI, therapists medical) |
| Informed consent | X | |||||||||
| Inclusion/exclusion criteria | X | |||||||||
| Medical history | X | |||||||||
| Notification of existing and planned BPBI care | X*
|
|||||||||
| Active and passive shoulder range of motion | X*
|
X | X | |||||||
| Active movement scale | X*
|
X | X | |||||||
| MRI of both shoulders | X | X | ||||||||
| mini-AHA scale | X*
|
X | ||||||||
| Ramdomisation criterion | X | |||||||||
| Randomisation | X | |||||||||
| BTI or Sham procedure | X | |||||||||
| Notification of care (surgery or other) | X | |||||||||
| Establishment of standardised physiotherapy follow-up | X | |||||||||
| Follow-up of physiotherapy | X | X | X | X | X | X | X | |||
| Adverse events | X | X | X | X | X | X | X | X | X | |
| Unblinding | X | |||||||||
X* 
: will be carried out before MRI.
AHA, assistive hand assessment; BPBI, brachial plexus birth injury; BTI, botulinum toxin injection.