Recruiting

Observational Study

Sponsor:

Medical College of Wisconsin

Code:

NCT06027294

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ischemic Conditioning

Study Details

Brief summary:

The muscles of stroke survivors can fatigue faster compared to muscles in people who have not had a stroke, which can limit how long a person with stroke can perform tasks such as walking. This study will examine how blood flow is regulated to the exercising leg muscle post-stroke, because if the muscle does not receive enough blood flow it will become fatigued. Finally, the investigators will use a safe and simple non-invasive intervention called ischemic conditioning, which has known effects to improve blood flow to exercising muscle and determine the effects on muscle fatigue.

Conditions

Stroke

Study ID

NCT06027294

Start date

Jan 11, 2024

Status verified date

Sep, 2025

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Be between 18-85 years of age
  • Able to give informed consent
  • ≥6 months post diagnosis of unilateral cortical or sub-cortical stroke
  • English speaking

Exclusion Criteria:

  • History of blood clots in the extremities or any condition in which compression of the thigh or transient ischemia is contraindicated (e.g. wounds in the leg)
  • Chronic pain syndrome
  • Low back or hip pain that interferes with lower extremity motor testing
  • History of head trauma
  • Comorbid neurological disorder
  • Peripheral vascular disease
  • Myocardial infarction in the previous year
  • Inability to follow 2 step commands
  • Condition where fatiguing contractions or resisted leg contractions are contraindicated
  • Resting SBP ≥160 mmHg or DBP ≥ 110 mmHg
  • Pregnancy or breastfeeding.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ischemic Conditioning

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 will receive six sessions of ischemic conditioning over the course of two weeks.

sham comparator: Ischemic Conditioning Sham

There will also be an IC Sham group which is identical to the IC intervention, except the cuff will only be inflated to 10 mmHg, which is not a high enough pressure to occlude arterial blood flow.

Interventions

Ischemic Conditioning

A cuff will be inflated to a pressure of 225 mmHg.

Primary outcome measure

  • Functional Sympatholysis Magnitude [ Time Frame: Years 3-5 ]

Central Contacts and Locations

Central contacts

Matthew Durand, Ph.D.

4149555619mdurand@mcw.edu

Jennifer Nguyen, BS

jnguyen@mcw.edu

Locations

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Matthew J Durand, Ph.D.

414-955-5619mdurand@mcw.edu

Marquette University

Recruiting

Milwaukee, Wisconsin, United States, 53233

Contacts

Allison S. Hyngstrom, PT, PhD

414-288-4566allison.hyngstrom@marquette.edu

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2025-09-25.