Effect of tibialis anterior focal muscle vibration for gait rehabilitation in hemiplegic individuals during the subacute phase after stroke: the NEUROVIB-AVC study protocol - a multicentric randomised controlled trial.

INTRODUCTION

Gait recovery remains one of the most determining factors in social participation for poststroke individuals, in whom ankle dorsiflexor function is closely related to gait speed. Focal muscle vibration has shown promising neurophysiological and clinical effects in neuromotor recovery. However, it remains to be determined whether tibialis anterior focal muscle vibration applied to the paretic limb could improve walking speed when implemented in early rehabilitation after stroke occurrence.

METHODS AND ANALYSIS

This study describes a multicentric randomised controlled trial in which 70 participants will be randomly assigned in a 1:1 ratio to the tibialis anterior focal muscle vibration group or the sham group, in addition to their conventional rehabilitation. Participants will receive 100 Hz vibration/sham for 30 min, five times per week, for 8 weeks. The primary outcome will be gait speed, as assessed through a 10 m walking test and will be compared between groups at the end of the intervention. Secondary outcomes will include gait abilities, neuromuscular clinical evaluations and neurophysiological measures. Outcomes will be assessed at baseline and across five visits during and after the intervention, until 16 weeks of follow-up.

ETHICS AND DISSEMINATION

Ethics approval was obtained from the French Ethics Committee 'Protection des Personnes Nord Ouest III' in 30 May 2023 (IDRCB: 2023-A00489-36). The results will be published in a peer-reviewed journal and presented at scientific conferences.

TRIAL REGISTRATION NUMBER

NCT05945212.