Clinical trial NCT05935670: Passive Limb Movement Study
Official title: Passive Limb Movement Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Vascular Diseases
Ischemic
Keywords: Ischemic Conditioning
Blood Flow
Peripheral Microvascular Function
Neuromuscular Function
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Marquette University
First posted: 2023-07-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Intervention 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).
Primary purpose: OTHER

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Ultrasound Measured Femoral Blood Flow during Passive Limb Movement (PLM)
timeFrame: Change from Baseline PLM Femoral Blood Flow after IC (3 hours)
measure: Ultrasound Measured Femoral Blood Flow during Active Limb Contraction
timeFrame: Change from Baseline MVCs Femoral Blood Flow after IC (3 hours)
Secondary outcomes:
measure: Ultrasound measured Femoral Blood Flow following Neuromuscular Fatigue Task
timeFrame: Post Ischemic Conditioning (15 minutes)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Matthew Durand, PhD
role: PRINCIPAL_INVESTIGATOR
References: