Passive Limb Movement Study (PLM)

Medical College of Wisconsin

Status: Enrolling

Conditions: Stroke; Vascular Diseases; Ischemic

Treatments: Device: Ischemic Conditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT05935670

PRO00047520

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Crossover Assignment

Masking: Triple Blind

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55 participants in 2 patient groups

Ischemic Conditioning - High

Experimental group

Description:

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).

Treatment:

Device: Ischemic Conditioning

Ischemic Conditioning - Low

Experimental group

Description:

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).

Treatment:

Device: Ischemic Conditioning