An interventional study of Ischemic Conditioning and Ischemic Conditioning Sham in Stroke, Stroke, Ischemic and Stroke Hemorrhagic, sponsored by Medical College of Wisconsin. Completed at 2 sites in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment
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.
This study will quantify the effects of Ischemic Conditioning and treadmill training on improvements in: walking speed, leg strength, neuromuscular fatigability and the hyperemic blood flow response to muscle contractions, and vascular endothelial function and aerobic exercise capacity. A randomized control design will be used with three groups of chronic stroke survivors enrolled for four weeks of training (3x/week; 12 sessions total). The groups are: IC + Treadmill Training, IC Sham + Treadmill Training, and IC only. We will also enroll a group of age- and sex-matched healthy control subjects who will undergo IC + Treadmill Training. All Aims will be tested concurrently over a five-year period. All studies will be performed in Cramer Hall at Marquette University in the Integrated Neural Engineering Rehabilitation Laboratories, the Human Performance Assessment Core, and the Physical Therapy Clinic.
Randomization of stroke patients to the three intervention groups will be performed by using randomized block designs (randomly chosen block sizes of 3, 6 and 9). This number accounts for possible dropouts and the use of non- parametric methods.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 132 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
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Inclusion Criteria (Stroke Survivors):
Exclusion Criteria (Stroke Survivors):
Inclusion Criteria (Healthy Control Subjects):
Exclusion Criteria (Healthy Control Subjects):
Study participants with prior history of stroke will receive both ischemic conditioning and treadmill training.
Procedure: Ischemic Conditioning · Procedure: Treadmill Training
Study participants with prior history of stroke will receive both ischemic conditioning sham and treadmill training.
Procedure: Ischemic Conditioning Sham · Procedure: Treadmill Training
Study participants with prior history of stroke will receive only ischemic conditioning.
Procedure: Ischemic Conditioning
Healthy control participants will receive both ischemic conditioning and treadmill training.
Procedure: Ischemic Conditioning · Procedure: Treadmill Training
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.
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.
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.
Self Selected Walking Speed
We will measure how fast participants walk during the 10 meter walk test.
Time frame: Change from baseline to 4 weeks.
Knee Extensor Leg Strength
Pre-treatment and after 1, 6, and 12 sessions of ischemic conditioning. We will also test 1 month post intervention
Time frame: Change from baseline to 4 weeks.
Knee Extensor Fatigability
Pre-treatment and after 1, 6, and 12 sessions of ischemic conditioning. We will also test 1 month post intervention
Time frame: Change from baseline to 4 weeks.
Flow Mediated Dilation of Non-Paretic Brachial Artery and Paretic Popliteal Artery
Pre-treatment and after 1, 6, and 12 sessions of ischemic conditioning. We will also test 1 month post intervention
Time frame: Change from baseline to 4 weeks.
Peak Oxygen Consumption
Using a recumbent bicycle and metabolic cart, we will test whole body oxygen consumption during a graded exercise test
Time frame: Change from baseline to 4 weeks.
Six minute walk test
Clinical test for walking endurance
Time frame: Change from baseline to 4 weeks.
Lower Extremity Fugl Meyer
Clinical test for coordination
Time frame: Change from baseline to 4 weeks.
Manual Muscle Test
Clinical test for strength
Time frame: Change from baseline to 4 weeks.
Modified Ashworth Scale
Clinical test for spasticity. The Modified Ashworth scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. Higher scores indicate worse spasticity. The scores and scale are as follows: 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of motion. 2. More marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
Time frame: Change from baseline to 4 weeks.
Bipolar Surface Electromyography (EMG) Measurements
Bipolar surface EMG of bilateral lower extremities will be measured during walking using electrodes placed on the following muscles: rectus femoris, vastus medialis, medial hamstrings, tibialis anterior, and medial gastrocnemius.
Time frame: Change from baseline to 4 weeks.
Voluntary Activation of Paretic Muscle
Voluntary activation (neural drive to the muscle) will be assessed by stimulating the motor nerve with a brief stimulus (superimposed twitch) while the subject performs a maximal voluntary contraction (MVC).
Time frame: Change from baseline to 4 weeks.
Surface EMG Motor Unit Measurements
Surface motor unit potentials will be recorded from the vastus lateralis (VL) muscle during muscle contractions using a multi-channel linear array of 64 EMG electrodes
Time frame: Change from baseline to 4 weeks.
Hyperemic Blood Flow in Response to Muscle Contractions
Blood flow through the superficial femoral artery will be measured before and immediately after knee extensor muscle contractions using Doppler ultrasound.
Time frame: Change from baseline to 4 weeks.
Heart Rate Variability (HRV)
We will use HRV analysis to determine the effects of IC and treadmill training on sympathetic and parasympathetic control of heart rate at the same time points as above.
Time frame: Change from baseline to 4 weeks.
Step Cadence
The number of steps per minute when walking at self-selected walking speed will be measured.
Time frame: Change from baseline to 4 weeks.
Step Length
The average step length during self-selected walking speed will be measured.
Time frame: Change from baseline to 4 weeks.
Step Velocity
Step velocity, the product of cadence and step length, expressed in units of distance per time, will be measured during self-selected walking speed.
Time frame: Change from baseline to 4 weeks.
Ground Reaction Force
Ground reaction force (N) will be measured during the different phases of gait during the 10 meter walk test and reported separately.
Time frame: Change from baseline to 4 weeks.
Ankle, Hip and Knee Joint Trajectories
Ankle, hip and knee joint trajectories (Angle) will be measured separately, in both legs, during the different phases of gait during the 10 meter walk test and reported as separate values.
Time frame: Change from baseline to 4 weeks.
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Medical College of Wisconsin