Sensory Augmentation Methods in Stroke (SAM)

VA Office of Research and Development

Status and phase

Completed

Early Phase 1

Conditions

Stroke

Treatments

Behavioral: Sensory Augmentation

Behavioral: Random Vibration

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT03988400

A3146-R

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Experience of a stroke 6 months prior to participation
Gait speed of at least 0.2 m/s
Ability to walk on a treadmill without a cane or walker
Provision of informed consent

Exclusion criteria

Evidence of cerebellar damage
Resting blood pressure higher than 220/110 mm Hg
History of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
Preexisting neurological disorders or dementia
Legal blindness or severe visual impairment
History of DVT or pulmonary embolism within 6 months
Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

44 participants in 2 patient groups

Sensory augmentation

Experimental group

Description:

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.

Treatment:

Behavioral: Sensory Augmentation

Random vibration

Active Comparator group

Description:

Treatment:

Behavioral: Random Vibration

Trial documents