Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation - Froedtert

Study Overview
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Brief Summary
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This study will be the first study to use ischemic preconditioning (IPC) as an intervention to improve stroke rehabilitation. IPC 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 IPC targets three physiological systems which are all affected by stroke, we hypothesize that repeated bouts of IPC during the first days to months following stroke (when the majority of recovery occurs) will make traditional rehabilitation strategies more effective.

Official Title
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Ischemic Preconditioning as an Intervention to Improve Stroke Rehabilitation

Conditions
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Stroke Rehabilitation, Ischemic Preconditioning, Physical and Rehabilitation Medicine

Intervention / Treatment
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* Other: Ischemic Preconditioning
* Other: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be between the ages of 40-80 able to give informed consent. be < 6 months post diagnosis of unilateral cortical stroke and have residual leg paresis. Exclusion Criteria: chronic low back or hip pain substance abuse head trauma with loss of conciousness in last 6 months neurodegenerative disorder participant taking any medication or supplement that adversely interacts with nitroglycerin (exclusion from nitro administration only, applies to outpatients only) participant has a known allergy to nitroglycerin (exclusion from nitro administration only, applies to outpatients only) resting systolic blood pressure < 90mmHg (exclusion from nitro administration only, applies to outpatients only) any condition where knee extension contractions are contraindicated people who are unable to follow multi step commands. pregnancy (DXA scan exclusion only) history of major psychiatric disorder participant has had a myocardial infarction in the last year participant has stage II hypertension (BP>160/100) participant is unable to contract knee muscles participant is unable to sit upright for 2 hours participant has a resting heart rate >100 beats per minute history of multiple strokes

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ischemic Preconditioning<br>Inflation of blood pressure cuff to 225 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times. | Other: Ischemic Preconditioning<br> <br> |
| Sham Comparator: Sham<br>Inflation of blood pressure cuff to 25 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times. | Other: Sham<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knee Extensor Strength |  | Admission into study and within 3 days of Discharge from Froedtert Hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Walking Speed |  | Admission into study and within 3 days of Discharge from Froedtert Hospital |