PLM: Passive Limb Movement Study

• Sponsor: Medical College of Wisconsin (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05935670
• Collaborator: Marquette University (Other)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 30.6
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Vascular Diseases; Ischemic	Device: Ischemic Conditioning	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: The investigators will enroll and complete visits for 30 individuals within the study including individuals post-stroke (n = 10), their age- and sex-matched controls (CON, n = 10), and young healthy controls (CONyoung, n = 10). 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).The investigators will enroll and complete visits for 30 individuals within the study including individuals post-stroke (n = 10), their age- and sex-matched controls (CON, n = 10), and young healthy controls (CONyoung, n = 10). 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).
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Passive Limb Movement Study
• Actual Study Start Date: Jun 13, 2023
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	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.
Experimental: 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).	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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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 Outcome Measures

1. Ultrasound measured Femoral Blood Flow following Neuromuscular Fatigue Task [Post Ischemic Conditioning (15 minutes)]

   Hyperemic Response to Fatiguing Muscle Contractions

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Medical College of Wisconsin
• Marquette University

Investigators

• Principal Investigator: Matthew Durand, PhD, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Matthew Durand, Associate Professor, Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT05935670
• Other Study ID Numbers: PRO00047520
• First Posted: Jul 7, 2023
• Last Update Posted: Jul 7, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Matthew Durand, Associate Professor, Medical College of Wisconsin: Ischemic Conditioning; Blood Flow; Peripheral Microvascular Function; Neuromuscular Function
• Additional relevant MeSH terms: Vascular Diseases

Study Results

No Results Posted as of Jul 7, 2023