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Passive Limb Movement Study (PLM)

Primary Purpose

Stroke, Vascular Diseases, Ischemic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ischemic Conditioning
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Ischemic Conditioning, Blood Flow, Peripheral Microvascular Function, Neuromuscular Function

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ischemic Conditioning - High

Ischemic Conditioning - Low

Arm 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).

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).

Outcomes

Primary Outcome Measures

Ultrasound Measured Femoral Blood Flow during Passive Limb Movement (PLM)
Microvascular response to single passive leg movement
Ultrasound Measured Femoral Blood Flow during Active Limb Contraction
Hyperemic Response to Maximal Voluntary Contractions (MVCs)

Secondary Outcome Measures

Ultrasound measured Femoral Blood Flow following Neuromuscular Fatigue Task
Hyperemic Response to Fatiguing Muscle Contractions

Full Information

First Posted
June 22, 2023
Last Updated
June 29, 2023
Sponsor
Medical College of Wisconsin
Collaborators
Marquette University
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1. Study Identification

Unique Protocol Identification Number
NCT05935670
Brief Title
Passive Limb Movement Study
Acronym
PLM
Official Title
Passive Limb Movement Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Marquette University

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Vascular Diseases, Ischemic
Keywords
Ischemic Conditioning, Blood Flow, Peripheral Microvascular Function, Neuromuscular Function

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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).
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ischemic Conditioning - High
Arm Type
Experimental
Arm 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).
Arm Title
Ischemic Conditioning - Low
Arm Type
Experimental
Arm 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).
Intervention Type
Device
Intervention Name(s)
Ischemic Conditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ultrasound Measured Femoral Blood Flow during Passive Limb Movement (PLM)
Description
Microvascular response to single passive leg movement
Time Frame
Change from Baseline PLM Femoral Blood Flow after IC (3 hours)
Title
Ultrasound Measured Femoral Blood Flow during Active Limb Contraction
Description
Hyperemic Response to Maximal Voluntary Contractions (MVCs)
Time Frame
Change from Baseline MVCs Femoral Blood Flow after IC (3 hours)
Secondary Outcome Measure Information:
Title
Ultrasound measured Femoral Blood Flow following Neuromuscular Fatigue Task
Description
Hyperemic Response to Fatiguing Muscle Contractions
Time Frame
Post Ischemic Conditioning (15 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Nguyen
Phone
414-955-5619
Email
jnguyen@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alicen Whitaker-Hilbig, PhD
Email
awhitakerhilbig@mcw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Durand, PhD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Durand, PhD
Email
mdurand@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Passive Limb Movement Study

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