Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Marquette University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ischemic Conditioning + Treadmill Training | Experimental | Study participants with prior history of stroke will receive both ischemic conditioning and treadmill training. |
|
| Ischemic Conditioning Sham + Treadmill Training | Placebo Comparator | Study participants with prior history of stroke will receive both ischemic conditioning sham and treadmill training. |
|
| Ischemic Conditioning Only | Active Comparator | Study participants with prior history of stroke will receive only ischemic conditioning. |
|
| Healthy Control - Ischemic Conditioning + Treadmill Training | Active Comparator | Healthy control participants will receive both ischemic conditioning and treadmill training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ischemic Conditioning | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Self Selected Walking Speed | We will measure how fast participants walk during the 10 meter walk test. | Change from baseline to 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Extensor Leg Strength | Pre-treatment and after 1, 6, and 12 sessions of ischemic conditioning. We will also test 1 month post intervention | Change from baseline to 4 weeks. |
| Knee Extensor Fatigability |
| Measure | Description | Time Frame |
|---|---|---|
| Six minute walk test | Clinical test for walking endurance | Change from baseline to 4 weeks. |
| Lower Extremity Fugl Meyer | Clinical test for coordination |
Inclusion Criteria (Stroke Survivors):
Exclusion Criteria (Stroke Survivors):
Inclusion Criteria (Healthy Control Subjects):
Exclusion Criteria (Healthy Control Subjects):
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States | ||
| Marquette University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 26, 2019 | Jul 26, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2019 | Jul 26, 2019 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 26, 2019 | Jul 26, 2019 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ischemic Conditioning Sham | Procedure | 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. |
|
| Treadmill Training | Procedure | 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. |
|
Pre-treatment and after 1, 6, and 12 sessions of ischemic conditioning. We will also test 1 month post intervention
| 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 | 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 | Change from baseline to 4 weeks. |
| Change from baseline to 4 weeks. |
| Manual Muscle Test | Clinical test for strength | 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
| 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. | 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). | 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 | 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. | 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. | Change from baseline to 4 weeks. |
| Step Cadence | The number of steps per minute when walking at self-selected walking speed will be measured. | Change from baseline to 4 weeks. |
| Step Length | The average step length during self-selected walking speed will be measured. | 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. | 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. | 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. | Change from baseline to 4 weeks. |
| Milwaukee |
| Wisconsin |
| 53233 |
| United States |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |