StrokeNCT04038697
Ischemic Conditioning Improves Walking Function Post Stroke
A study testing Ischemic Conditioning and Treadmill Training in people with Stroke and Stroke, Ischemic, run by Medical College of Wisconsin at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic
- What is being tested?
- Ischemic Conditioning and Treadmill Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Dec 2018to 9 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- be between ages of 18-85
- be able to give informed consent
Who cannot join
- 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
Show all 12Show fewer
- 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.
- Those listed above for stroke survivors
- History of Stroke
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Marquette University
Milwaukee, Wisconsin, 53233
About this study
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.
Read the 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.
- Conditions
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Stroke, Cardiovascular
- Being tested
- Ischemic Conditioning, Ischemic Conditioning Sham, Treadmill Training
- Keywords
- Stroke, Rehabilitation, Ischemic Conditioning, Treadmill Training
- Medical subject headings
- Stroke, Ischemic Stroke, Hemorrhagic Stroke, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic ConditioningProcedure or surgery
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 ShamProcedure or surgery
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 TrainingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Conditioning + Treadmill Training | Experimental | Study participants with prior history of stroke will receive both ischemic conditioning and treadmill training. Receives: Procedure: Ischemic Conditioning; Procedure: 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. Receives: Procedure: Ischemic Conditioning Sham; Procedure: Treadmill Training |
| Ischemic Conditioning Only | Active comparator | Study participants with prior history of stroke will receive only ischemic conditioning. Receives: Procedure: Ischemic Conditioning |
| Healthy Control - Ischemic Conditioning + Treadmill Training | Active comparator | Healthy control participants will receive both ischemic conditioning and treadmill training. Receives: Procedure: Ischemic Conditioning; Procedure: Treadmill Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Selected Walking Speed
We will measure how fast participants walk during the 10 meter walk test.
Measured: Change from baseline to 4 weeks.
Secondary outcomes (4)
Knee Extensor Leg Strength
Pre-treatment and after 1, 6, and 12 sessions of ischemic conditioning. We will also test 1 month post intervention
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start20 Dec 2018
- Primary completion16 Dec 2025
- Study completion9 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Marquette University
- Responsible party
- Principal investigator, Matthew J. Durand, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038697
- Sponsor's protocol ID
- HR-1812027206
- Status last verified
- Apr 2026
- First submitted
- 25 Jul 2019
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Conditioning Improves Walking Function Post Stroke
- ClinicalTrials.gov ID
- NCT04038697
- Acronym / sponsor ID
- HR-1812027206
- Conditions
- Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Stroke, Cardiovascular
- Keywords
- Stroke, Rehabilitation, Ischemic Conditioning, Treadmill Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Marquette University
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 9 Jan 2026 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ischemic Conditioning + Treadmill Training | Experimental | Procedure: Ischemic Conditioning, Procedure: Treadmill TrainingStudy participants with prior history of stroke will receive both ischemic conditioning and treadmill training. |
| Ischemic Conditioning Sham + Treadmill Training | Placebo comparator | Procedure: Ischemic Conditioning Sham, Procedure: Treadmill TrainingStudy participants with prior history of stroke will receive both ischemic conditioning sham and treadmill training. |
| Ischemic Conditioning Only | Active comparator | Procedure: Ischemic ConditioningStudy participants with prior history of stroke will receive only ischemic conditioning. |
| Healthy Control - Ischemic Conditioning + Treadmill Training | Active comparator | Procedure: Ischemic Conditioning, Procedure: Treadmill TrainingHealthy control participants will receive both ischemic conditioning and treadmill training. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- be between ages of 18-85
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischemic ConditioningIschemic 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. | Procedure or surgery | Healthy Control - Ischemic Conditioning + Treadmill Training, Ischemic Conditioning + Treadmill Training, Ischemic Conditioning Only |
| Ischemic Conditioning ShamIschemic 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. | Procedure or surgery | Ischemic Conditioning Sham + Treadmill Training |
| Treadmill TrainingParticipants 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. | Procedure or surgery | Healthy Control - Ischemic Conditioning + Treadmill Training, Ischemic Conditioning + Treadmill Training, Ischemic Conditioning Sham + Treadmill Training |
Primary outcome
Self Selected Walking Speed
Time frame: Change from baseline to 4 weeks.
We will measure how fast participants walk during the 10 meter walk test.
4 secondary outcomes
Knee Extensor Leg Strength
Time frame: Change from baseline to 4 weeks.
Knee Extensor Fatigability
Time frame: Change from baseline to 4 weeks.
Flow Mediated Dilation of Non-Paretic Brachial Artery and Paretic Popliteal Artery
Time frame: Change from baseline to 4 weeks.
Peak Oxygen Consumption
Time frame: Change from baseline to 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Cardiac CT Angiography in Acute Stroke Imaging (SCOPE-CT)
Acute Ischemic Stroke and Transient Ischemic Attacks
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
Recruiting
Music Therapy in Post-Stroke Patients: A Clinical Trial
CVA (Cerebrovascular Accident), Ictus
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic Conditioning and Treadmill Training in people with Stroke and Stroke, Ischemic, run by Medical College of Wisconsin at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self Selected Walking Speed (time frame: Change from baseline to 4 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.