Passive Limb Movement Study

NCT05935670 — Not applicable, Completed, 44 participants, Medical College of Wisconsin

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Registry	NCT05935670, acronym PLM
Status	Completed
Phase	Not applicable
Study type	Interventional; na, crossover, masking: triple, other
Enrollment	44 (Actual)
Sponsor	Medical College of Wisconsin (Other); collaborators: Marquette University
Conditions	Stroke, Vascular Diseases, Ischemic
Interventions	Ischemic Conditioning (Device)
Dates	start 2023-06-13, primary completion 2025-12-19, completion 2025-12-19, first posted 2023-07-07, last updated 2026-04-29
Locations	1 site in United States

-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 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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+Arms and interventions

Arm	Type	Interventions	Description
Ischemic Conditioning - High	Experimental	Device: Ischemic Conditioning	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).
Ischemic Conditioning - Low	Experimental	Device: Ischemic Conditioning	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).

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.

+Outcome measures

Primary outcomes

Ultrasound Measured Femoral Blood Flow during Passive Limb Movement (PLM) [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 [Change from Baseline MVCs Femoral Blood Flow after IC (3 hours)]: Hyperemic Response to Maximal Voluntary Contractions (MVCs)

Secondary outcomes

Ultrasound measured Femoral Blood Flow following Neuromuscular Fatigue Task [Post Ischemic Conditioning (15 minutes)]: Hyperemic Response to Fatiguing Muscle Contractions

+Eligibility

Sex: All, ages: 18 Years to 85 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Medical College of Wisconsin	Milwaukee, Wisconsin	United States

+Investigators

Matthew Durand, PhD, Principal investigator, Medical College of Wisconsin