Clinical trial NCT02964039: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
rehabilitation
gait
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-11-15
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)
timeFrame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
Secondary outcomes:
measure: Functional Gait Assessment (Change From Baseline)
timeFrame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
measure: Activities-specific Balance Confidence Scale (Change From Baseline)
timeFrame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
measure: 10-meter Walk Test (Change From Baseline)
timeFrame: baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks
measure: Fall Incidence
timeFrame: 6 months (during 12 week follow-up period)
measure: Fear of Falling
timeFrame: 6 months (at completion of 12-week Follow-up period)
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center, Charleston, SC
state: South Carolina
Study officials:
affiliation: Ralph H. Johnson VA Medical Center, Charleston, SC
name: Jesse C. Dean, PhD
role: PRINCIPAL_INVESTIGATOR
References: