A multimodal training with visual biofeedback in subacute stroke survivors: a randomized controlled trial

Early interventions maximizing patient's involvement are essential to promote gait restoration and motor recovery after stroke.

The aim of this study is 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.

Randomized controlled trial (NCT02439515).

Inpatient rehabilitation facility.

Subacute stroke survivors (less than 6 months from the first event) aged up to 90 years old.

Sixty-eight 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), spatiotemporal gait parameters, Six-Minute Walking Test, Functional Independence Measure, Motricity Index, Trunk Control Test, Berg Balance Scale, and Fall Efficacy Scale.

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=0.048). These percentages were even more unbalanced for patients with a moderate to severe gait impairment at baseline (91% versus 36%; P=0.008).

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.

The multimodal biofeedback training is a task-specific, repetitive and intensive training requiring a minimal supervision, which might result in a lower staff to patient ratio if organized in group sessions. Therefore, it can represent a good alternative for early stroke rehabilitation.