Clinical trial NCT03988400: Sensory Augmentation Methods in Stroke
Official title: Development of Sensory Augmentation Methods to Improve Post-stroke Gait Stability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stroke
Keywords: stroke
gait
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-06-17
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either an Experimental (n=22) or Control (n=22) group. These groups will differ only in terms of how vibration is delivered to the hip musculature during training sessions. In the Experimental group, vibration magnitude will be controlled by the real-time mechanical state of the user's body. In the Control group, vibration magnitude will be randomly varied.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Related or Serious Adverse Events
timeFrame: Cumulative over the course of the 4-week intervention
measure: Number of Training Sessions Attended
timeFrame: Cumulative over the course of the 4-week intervention
measure: Intervention Feasibility (Drop-out)
timeFrame: 4-weeks
measure: Change in Mechanics-dependent Adjustment of Paretic Foot Placement
timeFrame: 4-weeks
Secondary outcomes:
measure: Intervention Feasibility (Walking Time)
timeFrame: Cumulative over the course of the 4-week intervention
measure: Change in Fear of Falling
timeFrame: 4-weeks
measure: Change in Functional Gait Assessment Score
timeFrame: 4-weeks
measure: Change in Activity-specific Balance Confidence Score
timeFrame: 4-weeks
measure: Change in Overground Self-selected Gait Speed
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Jesse C. Dean, PhD
role: PRINCIPAL_INVESTIGATOR
References: