Ischemic Conditioning as an Intervention to Improve Motor Function in Chronic Stroke

Medical College of Wisconsin64 enrolled

Overview

The investigators will test whether an intervention called ischemic conditioning can improve paretic leg motor function in chronic stroke subjects.

This study will study ischemic conditioning (IC) as an intervention to improve motor function post-stroke. IC is a well studied, well tolerated intervention which has been shown to improve regional blood flow, motor neuron excitability and muscle function in multiple patient groups and in young, healthy subjects. Because IC targets three physiological systems which are all affected by stroke, the investigators hypothesize that repeated bouts of IC will result in improved motor function of the paretic leg.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke

Interventions

Ischemic ConditioningOTHER

Inflation of blood pressure cuff to 225 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times. Maximum 12 sessions over 4 weeks.

ShamOTHER

Inflation of blood pressure cuff to 25 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times. Maximum 12 sessions over 4 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. be between the ages of 18-85 2. able to give informed consent 3. be ≥ 6 months post diagnosis of unilateral cortical stroke and 4. have residual leg paresis. Exclusion Criteria: 1. chronic low back or hip pain 2. substance abuse 3. head trauma in last 6 months 4. neurodegenerative disorder 5. any uncontrolled medical condition 6. any condition where knee extension contractions are contraindicated 7. people who are unable to follow multi step commands. 8. people who cannot walk ≥ 10 ft without physical assistance. 9. history of major psychiatric disorder 10. participant has had a myocardial infarction in the last year 11. participant has uncontrolled hypertension 12. participant is unable to contract knee muscles

Locations (1)

Marquette University

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Leg Muscle Strength

Maximum voluntary contraction of the leg muscles, measured in Newton Meters, as assessed using a Biodex dynamometer.

Time frame: Within 1 year of admission into the study

Secondary Outcomes

Leg Muscle Fatigue

Duration the leg muscles can sustain contraction to a load level equal to 30% of a maximum voluntary contraction. Measurement units will be seconds the contraction can be held, as assessed using a Biodex Dynamometer.

Time frame: Within 1 year of admission into the study

Brachial Artery Flow Mediated Dilation

Percent dilation of the brachial artery

Time frame: Within 1 year of admission into the study

Data from ClinicalTrials.gov

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