BACKGROUND: Early interventions maximizing patient's involvement are essential to promote gait restoration and motor recovery after stroke. AIM: To evaluate the effects of a multimodal biofeedback training involving cycling augmented by Functional Electrical Stimulation (FES) and balance exercises on walking ability and motor recovery. DESIGN: Randomized controlled trial (NCT02439515). SETTING: Inpatient rehabilitation facility. POPULATION: Subacute stroke survivors (less than 6 months from the first event) with an age of up to 90 years old. METHODS: 68 participants were randomly allocated to an experimental group, performing 15 sessions of biofeedback FES-cycling training followed by 15 sessions of biofeedback balance training (20 minutes each) in addition to usual care (70 minutes), and a control group performing 30 sessions (90 minutes) of usual care. Participants were evaluated before training, after 15 sessions, after 30 sessions, and at 6-month follow-up through: gait speed (primary outcome), spatio-temporal gait parameters, Six Minute Walking Test, Functional Independence Measure, Motricity Index, Trunk Control Test, Berg Balance Scale, and Fall Efficacy Scale. RESULTS: Both groups significantly improved over time, but no group and interaction effects were found for any outcomes. The 73% of the experimental group achieved a clinically meaningful change in gait speed compared to the 38% of the control group (p-value = 0.048). These percentages were even more unbalanced for patients with a moderate to severe gait impairment at baseline (91% versus 36%; p-value = 0.008). CONCLUSIONS: The multimodal biofeedback training was not statistically superior to usual care, showing only a positive trend in favor of the experimental group on locomotion recovery. Patients initially not able to walk might be the best candidates for such a training.

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