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

VA Office of Research and Development

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Activity matched control; Behavioral: Error augmentation; Behavioral: Error reduction

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02964039

RX002256 (Other Grant/Funding Number)

N2256-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 3 patient groups

Error reduction

Experimental group

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.

Treatment:

Behavioral: Error reduction

Error augmentation

Experimental group

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.

Treatment:

Behavioral: Error augmentation

Activity matched control

Sham Comparator group

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.

Treatment:

Behavioral: Activity matched control