A RCT to Evaluate the Safety, Feasibility, and Efficacy of a Novel Vibrational Feedback Device to Facilitate Exoskeleton-assisted Walking Training for Patients with SCI

Individuals who sustain spinal cord injuries (SCI) often have deficits in lower extremity strength and stability which cause significant impairments in functional ambulation. Exoskeletons are wearable robots that assist individuals with walking over ground. Assisted walking interventions provided to persons with SCI have reduced the impact of paralysis on a broad range of body structures, body functions, and activities. Exoskeletons are now available for use in the research and clinical settings. Researchers have observed a significant learning curve to exoskeleton-assisted walking (EAW). Subjects must learn the proper changes in weight shifts that an exoskeleton requires to trigger each step in the gait. We hypothesize that impairment in proprioception (the sense of the relative position of one’s own body parts in space), a common effect in SCI, contributes to the difficulty in learning, and that by using a device that measures weight shifts in the feet and re-maps this sensory information to sensate areas (e.g. the arms), the user will learn the weight shifts required by the exoskeletons more efficiently.

Limited research has been done with vibrational feedback for EAW training. We have developed an accessory vibrational feedback device that senses the weight distribution in each foot and maps this distribution to an array of small vibrating motors to be used on parts of the body with intact sensation, such as the arms or chest.

In this pilot study, we will enroll both healthy subjects and those with spinal cord injuries to identify weight shifting patterns and body alignment patterns during EAW, and test how vibrational feedback may affect these biomechanical patterns. Additionally, we will study the safety and feasibility of our novel VFD and a commercially-available 3D motion tracking system during EAW. This study will provide valuable information on the effects that vibrational feedback has on gait and balance parameters during EAW.

Chung-Ying Tsai, PhD is the principal investigator of this project.