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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02964039
• Other study ID #: N2256-R
• Secondary ID: RX002256
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Ralph H. Johnson VA Medical Center, Charleston, SC	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Secondary	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).	baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Secondary	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).	baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Secondary	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).	baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Secondary	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	6 months (during 12 week follow-up period)
Secondary	Fear of Falling	Self-report statement of whether a participant has a fear of falling	6 months (at completion of 12-week Follow-up period)