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Completed

NCT Number: NCT02964039

A Novel Mechanics-based Intervention to Improve Post-stroke Stability

The purpose of this study is to determine whether a novel treadmill training intervention can improve the gait stabilization strategy used by individuals who have experienced a stroke.

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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

Not applicable

Primary location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

About this study

Every year, approximately 15,000 American Veterans experience a stroke, with an estimated cost of acute and follow-up care in the hundreds of millions of dollars. Following a stroke, the restoration or improvement of walking is a high-ranking goal among patients, but only about half of the population is able to return to typical levels of community ambulation. The resultant decrease in independent mobility is strongly associated with a decline in quality of life. Gait instability is a common contributor to limited mobility through either an increased fall-risk or fear of falling, but current interventions to address post-stroke gait instability have had limited success. This project will conduct initial testing of a novel elastic force-field designed to improve post-stroke gait stability through targeted motor learning. The results of these experiments will serve as the basis for the development of novel gait rehabilitation techniques, which have the potential to increase the quality of life of thousands of Veterans and save millions of dollars.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 21 years old
  • Experience of a stroke 6 months prior to participation
  • Preferred overground gait speed of at least 0.2 m/s
  • Ability to walk at self-selected speed for 3 minutes without a cane or walker
  • Provision of informed consent.

Exclusion criteria

  • Resting heart rate above 110 beats/min
  • Resting blood pressure higher than 200/110 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
  • History of major head trauma
  • Legal blindness or severe visual impairment
  • Life expectancy <1 yr; 8)
  • History of deep vein thrombosis 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

Error reduction

Behavioral

During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke.

Error augmentation

Behavioral

During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke.

Activity matched control

Behavioral

During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke.

Primary outcomes

  1. Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)

    Time frame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks

    A custom measure that quantifies the strength of the relationship between body mechanics and foot placement. This measure falls within a relatively narrow range among neurologically intact controls, but is substantially reduced in some individuals who have experienced a stroke, indicating a reduced ability to stabilize their gait pattern. This measure relates the mechanical state of the body at the start of each step (mediolateral pelvis displacement and velocity of the pelvis relative to the stance foot) to the step width at the end of the step. Specifically, the partial linear correlation between pelvis displacement and step width was calculated, accounting for variation in pelvis velocity.

    The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).

Secondary outcomes

  1. Functional Gait Assessment (Change From Baseline)

    Time frame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks

    A commonly-used clinical test to quantify balance and stability during various walking tasks. The minimum value is 0, the maximum value is 30, and higher scores indicate better outcomes. The total maximum value of 30 is calculated as the sum of 10 subscores, each of which has a scoring range of 0-3 and represents a distinct walking task.

    The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).

  2. Activities-specific Balance Confidence Scale (Change From Baseline)

    Time frame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks

    A commonly-used clinical scale that quantifies an individual's confidence in performing various tasks requiring balance. The minimum value is 0, the maximum value is 100, and higher scores indicate a better outcome. The overall score is calculated as the mean of 16 subscores, each of which can range of 0 to 100 and represents self-efficacy at a distinct movement task.

    The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).

  3. 10-meter Walk Test (Change From Baseline)

    Time frame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks

    A commonly-used clinical test to quantify general gait function. Walking speed is measured during the middle 6-meter portion of a 10-meter straight line path.

    The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).

  4. Fall Incidence

    Time frame: 6 months (during 12 week follow-up period)

    Self-report history of fall occurrence, quantified by the average number of falls per participant in each group during the 12-week period that followed completion of the study's intervention component

  5. Fear of Falling

    Time frame: 6 months (at completion of 12-week Follow-up period)

    Self-report statement of whether a participant has a fear of falling

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

A Novel Mechanics-based Intervention to Improve Post-stroke Gait Stability

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2016
Registry last updated
Jun 3, 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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