Back to resultsIschemic Conditioning Improves Walking Function Post Stroke
Primary Purpose
Stroke, Stroke, Ischemic, Stroke Hemorrhagic
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ischemic Conditioning
Ischemic Conditioning Sham
Treadmill Training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Ischemic Conditioning, Treadmill Training
Eligibility Criteria
Inclusion Criteria (Stroke Survivors):
- 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
Exclusion Criteria (Stroke Survivors):
- 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.
Inclusion Criteria (Healthy Control Subjects):
- be between ages of 18-85
- be able to give informed consent
Exclusion Criteria (Healthy Control Subjects):
- Those listed above for stroke survivors
- History of Stroke
Sites / Locations
- Medical College of WisconsinRecruiting
- Marquette UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Ischemic Conditioning + Treadmill Training
Ischemic Conditioning Sham + Treadmill Training
Ischemic Conditioning Only
Healthy Control - Ischemic Conditioning + Treadmill Training
Arm Description
Study participants with prior history of stroke will receive both ischemic conditioning and treadmill training.
Study participants with prior history of stroke will receive both ischemic conditioning sham and treadmill training.
Study participants with prior history of stroke will receive only ischemic conditioning.
Healthy control participants will receive both ischemic conditioning and treadmill training.
Outcomes
Primary Outcome Measures
Self Selected Walking Speed
We will measure how fast participants walk during the 10 meter walk test.
Secondary Outcome Measures
Knee Extensor Leg Strength
Pre-treatment and after 1, 6, and 12 sessions of ischemic conditioning. We will also test 1 month post intervention
Knee Extensor Fatigability
Pre-treatment and after 1, 6, and 12 sessions of ischemic conditioning. We will also test 1 month post intervention
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
Peak Oxygen Consumption
Using a recumbent bicycle and metabolic cart, we will test whole body oxygen consumption during a graded exercise test
Full Information
NCT ID
NCT04038697
First Posted
July 25, 2019
Last Updated
December 13, 2022
Sponsor
Medical College of Wisconsin
Collaborators
Marquette University
1. Study Identification
Unique Protocol Identification Number
NCT04038697
Brief Title
Ischemic Conditioning Improves Walking Function Post Stroke
Official Title
Ischemic Conditioning Improves Walking Function Post Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Marquette University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Stroke, Cardiovascular
Keywords
Stroke, Rehabilitation, Ischemic Conditioning, Treadmill Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ischemic Conditioning + Treadmill Training
Arm Type
Experimental
Arm Description
Study participants with prior history of stroke will receive both ischemic conditioning and treadmill training.
Arm Title
Ischemic Conditioning Sham + Treadmill Training
Arm Type
Placebo Comparator
Arm Description
Study participants with prior history of stroke will receive both ischemic conditioning sham and treadmill training.
Arm Title
Ischemic Conditioning Only
Arm Type
Active Comparator
Arm Description
Study participants with prior history of stroke will receive only ischemic conditioning.
Arm Title
Healthy Control - Ischemic Conditioning + Treadmill Training
Arm Type
Active Comparator
Arm Description
Healthy control participants will receive both ischemic conditioning and treadmill training.
Intervention Type
Procedure
Intervention Name(s)
Ischemic Conditioning
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ischemic Conditioning Sham
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Treadmill Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self Selected Walking Speed
Description
We will measure how fast participants walk during the 10 meter walk test.
Time Frame
Change from baseline to 4 weeks.
Secondary Outcome Measure Information:
Title
Knee Extensor Leg Strength
Description
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.
Title
Knee Extensor Fatigability
Description
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.
Title
Flow Mediated Dilation of Non-Paretic Brachial Artery and Paretic Popliteal Artery
Description
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.
Title
Peak Oxygen Consumption
Description
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.
Other Pre-specified Outcome Measures:
Title
Six minute walk test
Description
Clinical test for walking endurance
Time Frame
Change from baseline to 4 weeks.
Title
Lower Extremity Fugl Meyer
Description
Clinical test for coordination
Time Frame
Change from baseline to 4 weeks.
Title
Manual Muscle Test
Description
Clinical test for strength
Time Frame
Change from baseline to 4 weeks.
Title
Modified Ashworth Scale
Description
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
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.
More marked increase in muscle tone through most of the range of motion, but affected part(s) easily moved
Considerable increase in muscle tone, passive movement difficult
Affected part(s) rigid in flexion or extension
Time Frame
Change from baseline to 4 weeks.
Title
Bipolar Surface Electromyography (EMG) Measurements
Description
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.
Title
Voluntary Activation of Paretic Muscle
Description
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.
Title
Surface EMG Motor Unit Measurements
Description
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.
Title
Hyperemic Blood Flow in Response to Muscle Contractions
Description
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.
Title
Heart Rate Variability (HRV)
Description
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.
Title
Step Cadence
Description
The number of steps per minute when walking at self-selected walking speed will be measured.
Time Frame
Change from baseline to 4 weeks.
Title
Step Length
Description
The average step length during self-selected walking speed will be measured.
Time Frame
Change from baseline to 4 weeks.
Title
Step Velocity
Description
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.
Title
Ground Reaction Force
Description
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.
Title
Ankle, Hip and Knee Joint Trajectories
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (Stroke Survivors):
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
Exclusion Criteria (Stroke Survivors):
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.
Inclusion Criteria (Healthy Control Subjects):
be between ages of 18-85
be able to give informed consent
Exclusion Criteria (Healthy Control Subjects):
Those listed above for stroke survivors
History of Stroke
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew J Durand, Ph.D.
Phone
4149555619
Email
mdurand@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Allison S Hyngstrom, PT, Ph.D.
Phone
4142884566
Email
allison.hyngstrom@marquette.edu
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew J Durand, Ph.D.
Phone
414-955-5619
Email
mdurand@mcw.edu
Facility Name
Marquette University
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison S. Hyngstrom, PT, PhD
Phone
414-288-4566
Email
allison.hyngstrom@marquette.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Ischemic Conditioning Improves Walking Function Post Stroke
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