NCT03988400

Sensory Augmentation Methods in Stroke

Development of Sensory Augmentation Methods to Improve Post-stroke Gait Stability

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Many chronic stroke survivors have poor walking balance, contributing to an increased risk of falls and fear of falling. One factor contributing to these balance deficits is a reduced ability to place the feet appropriately when walking. This study investigates whether enhancing the sensory information available to chronic stroke survivors while they walk improves their foot placement accuracy and balance.

Detailed description

The objective of this project is to test a method of providing real-time augmentation of hip proprioceptive feedback during post-stroke walking. The sensory information available to participants will be augmented by providing vibration of the hip abductor musculature that is scaled to the near-real-time mechanical state of their body. The central hypothesis is that augmented proprioception will improve participants' perception of their body's motion, thus increasing the mechanics-dependent modulation of foot placement, an important gait stabilization strategy. This clinical trial will establish the safety, feasibility, and efficacy of a rehabilitation intervention centered on repeated exposure to sensory augmentation during gait. Specifically, participants in the experimental group will complete training sessions twice a week for four weeks in which they receive sensory augmentation during \~30 minutes of treadmill walking. Participants in the activity-matched control group will perform the same task, except the hip vibration will be randomly delivered, not linked to the body's actual mechanical state. Changes in walking balance and foot placement accuracy will be quantified over the course of the intervention.

Conditions

• Stroke

Interventions

Type	Name	Description
BEHAVIORAL	Sensory Augmentation	Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
BEHAVIORAL	Random Vibration	Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.

Timeline

• Start date: 2022-04-04
• Primary completion: 2023-04-26
• Completion: 2023-04-26
• First posted: 2019-06-17
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

1 site across 1 country: United States