RecruitingNot ApplicableNCT04038697

Ischemic Conditioning Improves Walking Function Post Stroke

Sponsor

Medical College of Wisconsin

Enrollment

120 participants

Start Date

Dec 20, 2018

Study Type

INTERVENTIONAL

Conditions

Stroke, Ischemic Stroke Stroke Hemorrhagic Stroke, Cardiovascular

Summary

This innovative study will address scientific and clinical areas relatively unexplored in chronic stroke that could lead to greater recovery of walking. Ischemic Conditioning (IC) is a non-invasive, simple procedure that improves motor function, exercise performance and cardiovascular function in healthy controls, but it has never been applied to the stroke population. We postulate that IC enhances the recruitment of motoneurons and results in positive neural adaptations, improves vascular endothelial function and peripheral blood flow, and together these improvements result in an increased capacity to exercise and faster walking speed. Future studies will examine the effects of IC and traditional therapy at different time points of recovery post stroke, durability of IC, molecular mechanisms of neural and cardiovascular adaptation and the efficacy compared with other adjuncts.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria6

be ≥ 1 year post diagnosis of a unilateral, cortical stroke and have residual lower extremity paresis
be between the ages of 18-85
be able to give informed consent
walk slower than normative values based on age and sex
be between ages of 18-85
be able to give informed consent

Exclusion Criteria12

history of deep vein thrombosis or any condition in which transient ischemia to the lower extremity is contraindicated
inability to follow 2 step commands
chronic low back or hip pain
history of substance abuse
history of head trauma
comorbid neurological disorder
any uncontrolled medical condition
pacemaker
any condition where fatiguing contractions or resisted leg contractions are contraindicated
inability to walk for 5 minute bouts on a treadmill with a harness supporting up to 50% of the body weight at 80% of over-ground self-selected walking speed.
Those listed above for stroke survivors
History of Stroke

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Interventions

PROCEDUREIschemic Conditioning

Ischemic conditioning is a well-defined, non-invasive procedure which consists of inflating a blood pressure cuff around a limb (in our study, the paretic leg), inflating the cuff to 225 mmHg to occlude blood flow to the limb for 5 minutes, releasing the cuff for 5 minutes, and repeating 5 times. In our study, participants assigned to the IC Only and IC + Treadmill Training groups will undergo twelve sessions of ischemic conditioning over a four-week period.

PROCEDUREIschemic Conditioning Sham

Ischemic conditioning sham consists of the same setup as ischemic conditioning, which consists of inflating a blood pressure cuff around a limb (in our study, the paretic leg), inflating the cuff to 10 mmHg for 5 minutes, releasing the cuff for 5 minutes, and repeating 5 times. 10 mmHg is a sufficient inflation pressure for study participants to perceive some cuff tightness, but is not high enough to occlude blood flow. In our study, participants assigned to the IC Sham + Treadmill Training groups will undergo twelve sessions of ischemic conditioning sham over a four-week period.

PROCEDURETreadmill Training

Participants will perform 3 treadmill training sessions/week for a 4 week period (12 sessions total). Treadmill training will immediately follow IC or IC Sham. Personnel performing the treadmill training will be blinded to the IC treatment group. Subjects will walk on a treadmill for six, 5-minute intervals. Walking speed will be continuously adjusted to maintain heart rate between 50% and 60% of age-adjusted heart rate reserve to minimize the confounder of intensity. If individuals cannot walk at 80% of their overground self-selected walking speed, for 5 minutes, they will be assisted into a body weight support harness. Body weight support will be adjusted (up to 50%) such that individuals can walk at 80% of their over ground walking speed for five minutes and adjusted accordingly throughout the session. Participants assigned to the Treadmill + IC and Treadmill + IC Sham groups will receive Treadmill Training.