Back to resultsA Novel Mechanics-based Intervention to Improve Post-stroke Stability
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Error reduction
Error augmentation
Activity matched control
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, rehabilitation, gait
Eligibility Criteria
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.
Sites / Locations
- Ralph H. Johnson VA Medical Center, Charleston, SC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Error reduction
Error augmentation
Activity matched control
Arm Description
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Outcomes
Primary Outcome Measures
Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)
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 Outcome Measures
Functional Gait Assessment (Change From Baseline)
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).
Activities-specific Balance Confidence Scale (Change From Baseline)
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).
10-meter Walk Test (Change From Baseline)
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).
Fall Incidence
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
Fear of Falling
Self-report statement of whether a participant has a fear of falling
Full Information
NCT ID
NCT02964039
First Posted
November 4, 2016
Last Updated
December 1, 2021
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02964039
Brief Title
A Novel Mechanics-based Intervention to Improve Post-stroke Stability
Official Title
A Novel Mechanics-based Intervention to Improve Post-stroke Gait Stability
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, rehabilitation, gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Error reduction
Arm Type
Experimental
Arm Description
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Arm Title
Error augmentation
Arm Type
Experimental
Arm Description
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Arm Title
Activity matched control
Arm Type
Sham Comparator
Arm Description
Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.
Intervention Type
Behavioral
Intervention Name(s)
Error reduction
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Error augmentation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Activity matched control
Intervention Description
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 Outcome Measure Information:
Title
Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)
Description
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).
Time Frame
baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Secondary Outcome Measure Information:
Title
Functional Gait Assessment (Change From Baseline)
Description
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).
Time Frame
baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Title
Activities-specific Balance Confidence Scale (Change From Baseline)
Description
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).
Time Frame
baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Title
10-meter Walk Test (Change From Baseline)
Description
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).
Time Frame
baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Title
Fall Incidence
Description
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
Time Frame
6 months (during 12 week follow-up period)
Title
Fear of Falling
Description
Self-report statement of whether a participant has a fear of falling
Time Frame
6 months (at completion of 12-week Follow-up period)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse C. Dean, PhD
Organizational Affiliation
Ralph H. Johnson VA Medical Center, Charleston, SC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ralph H. Johnson VA Medical Center, Charleston, SC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified, anonymized data sets will be available to other investigators or members of the public upon request. These data sets will be made available upon completion of data collection, processing, and initial statistical analyses. The data sets will include physiological measures related to functional mobility, as well as the results of clinical tests.
Learn more about this trial
A Novel Mechanics-based Intervention to Improve Post-stroke Stability
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