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Completed

NCT Number: NCT05935670

Passive Limb Movement 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemia Ischemic Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Ischemic Conditioning

Device

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.

Primary outcomes

  1. 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

  2. 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)

Secondary outcomes

  1. Ultrasound measured Femoral Blood Flow following Neuromuscular Fatigue Task

    Time frame: Post Ischemic Conditioning (15 minutes)

    Hyperemic Response to Fatiguing Muscle Contractions

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Marquette University

Registry information

Acronym: PLM

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2023
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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