Outcome measures throughout the study
Inclusion | First evaluation | Mid-programme evaluation | End of programme evaluation | First follow-up evaluation | Second follow-up evaluation | During 8 weeks | |
Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | ||
Week 4 | Week 8 | Week 12 | Week 16 | ||||
Eligibility criteria | ✕ | ||||||
Medical evaluation | ✕ | ✕ | ✕ | ✕ | ✕ | ✕ | |
Gait Speed 10MWT (speed, m/s) | ✕ | ✕ | ✕ | ✕ | ✕ | ||
Gait performance 2mWT (distance, m) | ✕ | ✕ | ✕ | ✕ | ✕ | ||
3D Gait Analysis | ✕ | ✕ | |||||
Lower limb strength (MRC/60) | ✕ | ✕ | ✕ | ✕ | ✕ | ✕ | |
Maximal Voluntary Contraction Ankle dorsiflexors (Force/Nm) | ✕ | ✕ | ✕ | ✕ | ✕ | ||
Lower limb spasticity (MAS/20) | ✕ | ✕ | ✕ | ✕ | ✕ | ||
Lower limb function (FMA-LE/34) | ✕ | ✕ | ✕ | ✕ | ✕ | ||
Questionnaires (ABILOCO, FACIT, Barthel) | ✕ | ✕ | ✕ | ✕ | ✕ | ||
H-reflex/M-wave (%) | ✕ | ✕ | ✕ | ✕ | ✕ | ||
Voluntary activation (%) | ✕ | ✕ | ✕ | ✕ | ✕ | ||
TA 100 Hz FMV/Sham FMV (5×30 min/week) | ✕ | ||||||
Conventional rehabilitation | ✕ |
Red cross is indicated for the main outcome and blue ones for secondary outcomes.
ABILOCO, locomotion ability measure; 3D, three dimensions; FACIT, Functional Assessment of Chronic Illness Therapy; FMA-LE, Fugl-Meyer assessment of lower extremity; FMV, focal muscular vibration; MAS, modified Ashworth scale; MRC, Medical Research Council; 2mWT, 2 min walking test; 10MWT, 10 m walking test; Nm, Newton metre; TA, tibialis anterior.