StrokePLMNCT05935670
Passive Limb Movement Study
A study testing Ischemic Conditioning in people with Stroke and Vascular Diseases, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Stroke survivors have compromised vascular function which may contribute to secondary stroke risk, cardiovascular disease, and may limit their exercise tolerance. No studies have examined how femoral blood flow responds to both passive leg movement, a measure of microvascular function, as well as active leg… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Vascular Diseases, Ischemic
- What is being tested?
- Ischemic Conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2023to 19 Dec 2025
- 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
- Individuals Post-Stroke
- 18 - 85 years of age
- Cortical or sub-cortical stroke ≥ 6 months ago with residual hemiparesis
- Able to give informed consent and follow 2-step command.
- English Speaking
- Age- and Sex-Matched Controls (CON)
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- Matched to age of individual post- stroke ± 5 years.
- Matched to sex of individual post-stroke
- Able to give informed consent and follow 2-step command.
- English Speaking
- Young Healthy Adults (CONyoung)
- Age 18-30 years old
- Able to give informed consent and follow 2-step command.
- English Speaking
Who cannot join
- All Groups
- Unable to stand from chair and walk 10 meters without physical assistance from another person (able to use assistive device).
- History of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (i.e., wounds in the leg).
- Chronic lasting symptoms (> 6 months) of severe COVID-19 (i.e., hospitalization)
- Low back or hip pain that limits lower extremity motor testing.
- History of head trauma or concussion within the past 6 months
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- Comorbid neurological disorder
- Peripheral vascular disease
- Myocardial infarction in the previous year
- Condition where fatiguing contractions or resisted leg contractions are contraindicated
- Resting SBP ≥180 mmHg or DBP ≥ 100 mmHg
- Pregnancy or breastfeeding.
- Other significant medical condition likely to influence study or jeopardize safety as assessed by the Primary Investigator
- CON and CONyoung
- History of Stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Stroke survivors have compromised vascular function which may contribute to secondary stroke risk, cardiovascular disease, and may limit their exercise tolerance. No studies have examined how femoral blood flow responds to both passive leg movement, a measure of microvascular function, as well as active leg contractions, a measure of the hyperemic response to exercise. Leg muscles with a reduced blood flow response to movement could be associated with decreased neuromuscular function, such as leg strength and fatigue. Preliminary data showing a single bout of ischemic conditioning may improve vascular function and muscle activation in healthy adults and individuals post-stroke. Therefore, the investigators want to examine if ischemic conditioning will also improve the blood flow response to passive leg movements as well as during single leg active contractions.
- Conditions
- Stroke, Vascular Diseases, Ischemic
- Being tested
- Ischemic Conditioning
- Keywords
- Ischemic Conditioning, Blood Flow, Peripheral Microvascular Function, Neuromuscular Function
- Medical subject headings
- Stroke, Vascular Diseases, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic ConditioningDevice
The cuff will be placed around the proximal, paretic thigh (or dominant thigh for controls) and inflated for 5 minutes in a supine or semi-reclined position, then released for a 5-minute recovery period. Five cycles of inflation and recovery will be performed (45 minutes total).These inflations will be done using a cuff similar to what is used for taking blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Conditioning - High | Experimental | During each testing session, the investigators will be measuring how one treatment of ischemic conditioning effects leg blood flow and muscle function. One day participants will receive a high cuff inflation pressure on the leg, called ischemic conditioning - high (225 mmHg). Receives: Device: Ischemic Conditioning |
| Ischemic Conditioning - Low | Experimental | During each testing session, the investigators will be measuring how one treatment of ischemic conditioning effects leg blood flow and muscle function. One day participants will receive a low cuff inflation pressure on the leg, called ischemic conditioning - low (25 mmHg). Receives: Device: Ischemic Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Measured Femoral Blood Flow during Passive Limb Movement (PLM)
Microvascular response to single passive leg movement
Measured: Change from Baseline PLM Femoral Blood Flow after IC (3 hours)
Ultrasound Measured Femoral Blood Flow during Active Limb Contraction
Hyperemic Response to Maximal Voluntary Contractions (MVCs)
Measured: Change from Baseline MVCs Femoral Blood Flow after IC (3 hours)
Secondary outcomes (1)
Ultrasound measured Femoral Blood Flow following Neuromuscular Fatigue Task
Hyperemic Response to Fatiguing Muscle Contractions
Measured: Post Ischemic Conditioning (15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start13 Jun 2023
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
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
- Other
- Allocation
- Not applicable
- Intervention model
- Crossover
- Model description
- The investigators will enroll and complete visits for 55 individuals within the study including individuals post-stroke (n = 20), their age- and sex-matched controls (CON, n = 20), and young healthy controls (CONyoung, n = 15). This study includes 2 visits to the Athletic and Human Performance Research Center (AHPRC) at Marquette University. The investigators will measure femoral blood flow to passive limb movement and active contractions pre-/post- ischemic conditioning high (225 mmHg) and ischemic conditioning low (25 mmHg).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 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
- Investigators
- Matthew Durand, PhD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05935670
- Sponsor's protocol ID
- PRO00047520
- Acronym
- PLM
- Status last verified
- Apr 2026
- First submitted
- 22 Jun 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Limb Movement Study
- ClinicalTrials.gov ID
- NCT05935670
- Acronym / sponsor ID
- PLM / PRO00047520
- Conditions
- Stroke, Vascular Diseases, Ischemic
- Keywords
- Ischemic Conditioning, Blood Flow, Peripheral Microvascular Function, Neuromuscular Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Marquette University
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 7 Jul 2023 (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.
Stroke survivors have compromised vascular function which may contribute to secondary stroke risk, cardiovascular disease, and may limit their exercise tolerance. No studies have examined how femoral blood flow responds to both passive leg movement, a measure of microvascular function, as well as active leg contractions, a measure of the hyperemic response to exercise. Leg muscles with a reduced blood flow response to movement could be associated with decreased neuromuscular function, such as leg strength and fatigue. Preliminary data showing a single bout of ischemic conditioning may improve vascular function and muscle activation in healthy adults and individuals post-stroke. Therefore, the investigators want to examine if ischemic conditioning will also improve the blood flow response to passive leg movements as well as during single leg active contractions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will enroll and complete visits for 55 individuals within the study including individuals post-stroke (n = 20), their age- and sex-matched controls (CON, n = 20), and young healthy controls (CONyoung, n = 15). This study includes 2 visits to the Athletic and Human Performance Research Center (AHPRC) at Marquette University. The investigators will measure femoral blood flow to passive limb movement and active contractions pre-/post- ischemic conditioning high (225 mmHg) and ischemic conditioning low (25 mmHg).
| Arm | Type | Receives |
|---|---|---|
| Ischemic Conditioning - High | Experimental | Device: Ischemic ConditioningDuring each testing session, the investigators will be measuring how one treatment of ischemic conditioning effects leg blood flow and muscle function. One day participants will receive a high cuff inflation pressure on the leg, called ischemic conditioning - high (225 mmHg). |
| Ischemic Conditioning - Low | Experimental | Device: Ischemic ConditioningDuring each testing session, the investigators will be measuring how one treatment of ischemic conditioning effects leg blood flow and muscle function. One day participants will receive a low cuff inflation pressure on the leg, called ischemic conditioning - low (25 mmHg). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Individuals Post-Stroke
- Age- and Sex-Matched Controls (CON)
- Young Healthy Adults (CONyoung)
Key exclusion criteria (15 listed)
- All Groups
- CON and CONyoung
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 ConditioningThe cuff will be placed around the proximal, paretic thigh (or dominant thigh for controls) and inflated for 5 minutes in a supine or semi-reclined position, then released for a 5-minute recovery period. Five cycles of inflation and recovery will be performed (45 minutes total).These inflations will be done using a cuff similar to what is used for taking blood pressure. | Device | Ischemic Conditioning - High, Ischemic Conditioning - Low |
Primary outcome
Ultrasound Measured Femoral Blood Flow during Passive Limb Movement (PLM)
Time frame: Change from Baseline PLM Femoral Blood Flow after IC (3 hours)
Microvascular response to single passive leg movement
Ultrasound Measured Femoral Blood Flow during Active Limb Contraction
Time frame: Change from Baseline MVCs Femoral Blood Flow after IC (3 hours)
Hyperemic Response to Maximal Voluntary Contractions (MVCs)
1 secondary outcome
Ultrasound measured Femoral Blood Flow following Neuromuscular Fatigue Task
Time frame: Post Ischemic Conditioning (15 minutes)
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 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Matthew Durand, PhD principal investigator
Medical College of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic Conditioning in people with Stroke and Vascular Diseases, run by Medical College of Wisconsin at 1 site 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 14 inclusion and 15 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 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Ultrasound Measured Femoral Blood Flow during Passive Limb Movement (PLM) (time frame: Change from Baseline PLM Femoral Blood Flow after IC (3 hours)). The study lists 2 primary outcomes in all. 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 29 Apr 2026.