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Completed

NCT Number: NCT03988400

Sensory Augmentation Methods in Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sensory Augmentation

Behavioral

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.

Random Vibration

Behavioral

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.

Primary outcomes

  1. Percentage of Participants With Related or Serious Adverse Events

    Time frame: Cumulative over the course of the 4-week intervention

    The investigators will monitor the safety of the intervention by quantifying the percentage of participants who experience an adverse event potentially related to the intervention (e.g. skin irritation; falls) or any serious adverse event (e.g. hospitalization; death). This information is gathered through participant self-report, or through communication with participant caregiver if necessary.

  2. Number of Training Sessions Attended

    Time frame: Cumulative over the course of the 4-week intervention

    The investigators will assess participant adherence as the number of training sessions attended (out of a maximum possible number of 8).

  3. Intervention Feasibility (Drop-out)

    Time frame: 4-weeks

    The investigators will assess participant drop-out as the number of participants who do not attend the final Assessment Session.

  4. Change in Mechanics-dependent Adjustment of Paretic Foot Placement

    Time frame: 4-weeks

    The primary effectiveness measure will be the change in participants' gait stabilization strategy over the course of the 4-week intervention. This will be quantified as the partial correlation between paretic mediolateral foot placement and mediolateral pelvis displacement at the start of the step over a 2-minute period of walking. The investigators will calculate the change in this metric from the initial (Week 0) assessment session to the final (Week 4) assessment session.

Secondary outcomes

  1. Intervention Feasibility (Walking Time)

    Time frame: Cumulative over the course of the 4-week intervention

    The investigators will quantify the total walking time across all training sessions (out of a maximum possible 312 minutes).

  2. Change in Fear of Falling

    Time frame: 4-weeks

    The investigators will assess the change in fear of falling (identified using a yes/no question of "do you have a fear of falling?") from the initial (Week 0) assessment session to the final (Week 4) assessment session.

  3. Change in Functional Gait Assessment Score

    Time frame: 4-weeks

    The investigators will quantify the change in Functional Gait Assessment score from the initial (Week 0) assessment session to the final (Week 4) assessment session. The initial score will be subtracted from the final score. The minimum value is 0, the maximum value is 30, and higher scores indicate a better outcome.

  4. Change in Activity-specific Balance Confidence Score

    Time frame: 4-weeks

    The investigators will quantify the change in Activity-specific Balance Confidence score from the initial (Week 0) assessment session to the final (Week 4) assessment session. The initial score will be subtracted from the final score. The minimum value is 0, the maximum value is 100, and higher scores indicate a better outcome.

  5. Change in Overground Self-selected Gait Speed

    Time frame: 4-weeks

    The investigators will quantify the change in overground self-selected gait speed from the initial (Week 0) assessment session to the final (Week 4) assessment session. The initial score will be subtracted from the final score.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: SAM

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 17, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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