Recruitment | Inclusion M0 | Follow-up visit at M1 | Follow-up visit at M2 | Follow-up visit at M6 | |
---|---|---|---|---|---|
Investigator | |||||
Patient information | ✓ | ||||
Informed consent | ✓ | ||||
Demographic dataa | ✓ | ||||
Randomization | ✓ | ||||
Gait classification | ✓ | ||||
Strokeb | ✓ | ||||
NIHSS | ✓ | ✓ | ✓ | ✓ | |
Fugl-Meyer (lower limb)c | ✓ | ✓ | ✓ | ✓ | |
FIM | ✓ | ✓ | ✓ | ✓ | |
mRS-SI | ✓ | ✓ | ✓ | ✓ | |
QoL-VAS | ✓ | ✓ | ✓ | ✓ | |
AEs and SAEs | ✓ | ✓ | ✓ | ||
Therapists | |||||
ST 10 MWT | ✓ | ✓ | ✓ | ✓ | |
DT 10 MWT | ✓ | ✓ | ✓ | ✓ | |
ST TUG | ✓ | ✓ | ✓ | ✓ | |
DT TUG | ✓ | ✓ | ✓ | ✓ | |
Neuropsychologist | |||||
Neuropsychological batteryd | ✓ | ✓ | ✓ | ✓ | |
Radiologist | |||||
MRI | ✓ 280 patients in 12 centers (4 and 6 months after stroke) | ||||
fMRI and fMRS | ✓ 20 patients at the Amiens center (4 and 6 months after stroke) |