Passive Limb Movement Study

NCT ID: NCT05935670

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-13
• Study Completion Date: 2025-12-31

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.

Conditions

Stroke; Vascular Diseases; Ischemic

Study Design

• Allocation Method: NA
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Ischemic Conditioning - High

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).

Group Type: EXPERIMENTAL

Ischemic Conditioning

Intervention Type: 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.

Ischemic Conditioning - Low

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).

Group Type: EXPERIMENTAL

Ischemic Conditioning

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marquette University

OTHER

Sponsor Role: collaborator

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Matthew J. Durand

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Durand, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer Nguyen

Role: CONTACT

jnguyen@mcw.edu

414-955-5619

Alicen Whitaker-Hilbig, PhD

Role: CONTACT

awhitakerhilbig@mcw.edu

Facility Contacts

Matthew Durand, PhD

Role: primary

mdurand@mcw.edu

Other Identifiers

PRO00047520

Identifier Type: -

Identifier Source: org_study_id