Passive Limb Movement Study

Stroke Clinical Trial

— PLM  

Official title:

Passive Limb Movement Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05935670
• Other study ID #: PRO00047520
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Medical College of Wisconsin
• Contact: Jennifer Nguyen
• Phone: 414-955-5619
• Email: jnguyen[@]mcw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic
• Stroke
• Vascular Diseases

Intervention

Device:
• Ischemic Conditioning
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.

Locations

Country	Name	City	State
United States	Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Marquette University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound Measured Femoral Blood Flow during Passive Limb Movement (PLM)	Microvascular response to single passive leg movement	Change from Baseline PLM Femoral Blood Flow after IC (3 hours)
Primary	Ultrasound Measured Femoral Blood Flow during Active Limb Contraction	Hyperemic Response to Maximal Voluntary Contractions (MVCs)	Change from Baseline MVCs Femoral Blood Flow after IC (3 hours)
Secondary	Ultrasound measured Femoral Blood Flow following Neuromuscular Fatigue Task	Hyperemic Response to Fatiguing Muscle Contractions	Post Ischemic Conditioning (15 minutes)