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Ischemic Conditioning for Stroke (PLM Trial)
N/A
Recruiting
Led By Matthew Durand, PhD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post ischemic conditioning (15 minutes)
Awards & highlights
PLM Trial Summary
This trial will assess if a single bout of ischemic conditioning can improve vascular function & muscle activation in stroke survivors, & help reduce risk of secondary stroke.
Who is the study for?
This trial is for stroke survivors aged 18-85 with residual hemiparesis from a stroke at least 6 months prior, and healthy adults aged 18-30. Participants must be able to understand instructions and communicate in English. Exclusions include severe mobility issues, recent severe COVID-19 or head trauma, other neurological disorders, heart attack within the last year, high blood pressure, pregnancy/breastfeeding, or conditions where leg compression is unsafe.Check my eligibility
What is being tested?
The study investigates whether ischemic conditioning can improve blood flow response during passive and active leg movements in individuals post-stroke. It aims to see if this treatment could enhance vascular function and muscle activation which might be compromised after a stroke.See study design
What are the potential side effects?
While specific side effects are not listed for ischemic conditioning in this summary, potential risks may include discomfort from the procedure itself such as temporary numbness or tingling due to restricted blood flow.
PLM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post ischemic conditioning (15 minutes)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post ischemic conditioning (15 minutes)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ultrasound Measured Femoral Blood Flow during Active Limb Contraction
Ultrasound Measured Femoral Blood Flow during Passive Limb Movement (PLM)
Secondary outcome measures
Ultrasound measured Femoral Blood Flow following Neuromuscular Fatigue Task
PLM Trial Design
2Treatment groups
Experimental Treatment
Group I: Ischemic Conditioning - LowExperimental Treatment1 Intervention
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 II: Ischemic Conditioning - HighExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ischemic Conditioning
2019
N/A
~90
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,683 Total Patients Enrolled
Marquette UniversityOTHER
62 Previous Clinical Trials
200,293 Total Patients Enrolled
Matthew Durand, PhDPrincipal InvestigatorMedical College of Wisconsin
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a head injury or concussion in the last 6 months.I have had a heart attack in the last year.I need help to stand and walk 10 meters, but I can use a device.I cannot do exercises that make my muscles very tired or involve pushing against something with my legs.I have a condition affecting the blood vessels outside my heart and brain.I have a history of blood clots in my legs or conditions that prevent pressure on my thigh.I have had severe COVID-19 symptoms for more than 6 months.I have low back or hip pain that affects my ability to move my legs.I have a neurological disorder.I had a stroke 6+ months ago, have some paralysis, can follow commands, and speak English.Your blood pressure is very high when you are resting.You have had a stroke in the past.I match the age and sex of a stroke patient, can follow instructions, and speak English.I am 18-30 years old, can follow instructions, and speak English.
Research Study Groups:
This trial has the following groups:- Group 1: Ischemic Conditioning - High
- Group 2: Ischemic Conditioning - Low
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who has the requisite qualifications to join this experiment?
"To be considered for this study, prospective participants must have suffered a stroke and should fall between 18-85 years of age. Approximately 30 individuals will be accepted into the trial."
Answered by AI
Is this research endeavor seeking out participants at present?
"This clinical trial is open for enrollment, as identified on clinicialtrials.gov. The medical research project was initially posted on June 13th 2023 and has since been adjusted with the most recent update occurring on June 29th of the same year."
Answered by AI
Is there an age threshold for eligibility in this clinical study?
"This investigation is open to applicants who are 18 years of age or older, and not yet 85."
Answered by AI
How many volunteers have joined the trial thus far?
"Affirmative. Clinicaltrials.gov data reveals that this research study, initially posted on June 13th 2023 is currently seeking participants. The trial needs to enroll 30 individuals at a single medical site."
Answered by AI
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