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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02964039
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Error reduction Behavioral: Error augmentation Behavioral: Activity matched control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Novel Mechanics-based Intervention to Improve Post-stroke Gait Stability
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020

Arm Intervention/treatment
Experimental: Error reduction
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.
Behavioral: Error reduction
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.

Experimental: Error augmentation
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.
Behavioral: Error augmentation
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.

Sham Comparator: Activity matched control
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.
Behavioral: Activity matched control
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 Measures :
  1. Partial correlation between pelvis displacement and paretic step width during gait (change from baseline) [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Functional Gait Assessment (change from baseline) [ Time Frame: 6 months ]
    A commonly-used clinical test to quantify balance and stability during various walking tasks

  2. Activities-specific Balance Confidence scale (change from baseline) [ Time Frame: 6 months ]
    A commonly-used clinical scale that quantifies an individual's confidence in performing various tasks requiring balance

  3. 10-meter walk test (change from baseline) [ Time Frame: 6 months ]
    A commonly-used clinical test to quantify general gait function

  4. Fall incidence (change from baseline) [ Time Frame: 6 months ]
    Self-report history of fall occurrence

  5. Fear of falling (change from baseline) [ Time Frame: 6 months ]
    Self-report statement of whether a participant has a fear of falling



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02964039


Locations
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United States, South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, United States, 29401-5799
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jesse C. Dean, PhD Ralph H. Johnson VA Medical Center, Charleston, SC
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02964039    
Other Study ID Numbers: N2256-R
RX002256 ( Other Grant/Funding Number: VA ORD )
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

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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
Keywords provided by VA Office of Research and Development:
stroke
rehabilitation
gait
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases