Real-time foot clearance biofeedback to assist gait rehabilitation following stroke: a randomized controlled trial protocol.

Background: The risk of falling is significantly higher in people with chronic stroke and it is, therefore, important to design interventions to improve mobility and decrease falls risk. Minimum toe clearance (MTC) is the key gait cycle event for predicting tripping-falls because it occurs mid-swing during the walking cycle where forward velocity of the foot is maximum. High forward velocity coupled with low MTC increases the probability of unanticipated foot-ground contacts. Training procedures to increase toe-ground clearance (MTC) have potential, therefore, as a falls-prevention intervention. The aim of this project is to determine whether augmented sensory information via real-time visual biofeedback during gait training can increase MTC.

Methods: Participants will be aged > 18 years, have sustained a single stroke (ischemic or hemorrhagic) at least six months previously, able to walk 50 m independently, and capable of informed consent. Using a secure web-based application (REDCap), 150 participants will be randomly assigned to either no-feedback (Control) or feedback (Experimental) groups; all will receive 10 sessions of treadmill training for up to 10 min at a self-selected speed over 5-6 weeks. The intervention group will receive real-time, visual biofeedback of MTC during training and will be asked to modify their gait pattern to match a required "target" criterion. Biofeedback is continuous for the first six sessions then progressively reduced (faded) across the remaining four sessions. Control participants will walk on the treadmill without biofeedback. Gait assessments are conducted at baseline, immediately following the final training session and then during follow-up, at one, three, and six months. The primary outcome measure is MTC. Monthly falls calendars will also be collected for 12 months from enrolment.

Discussion: The project will contribute to understanding how stroke-related changes to sensory and motor processes influence gait biomechanics and associated tripping risk. The research findings will guide our work in gait rehabilitation following stroke and may reduce falls rates. Treadmill training procedures incorporating continuous real-time feedback may need to be modified to accommodate stroke patients who have greater difficulties with treadmill walking.

Trial Registration: Australia New Zealand Clinical Trials Registry, ACTRN12617000250336 . Registered on 17 February 2017.