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Ischemic Conditioning for Stroke Recovery

N/A

Recruiting

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 ≥ 1 year post diagnosis of a unilateral, cortical stroke and have residual lower extremity paresis

walk slower than normative values based on age and sex

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 4 weeks.

Awards & highlights

Study Summary

This trial will explore the potential benefits of a non-invasive, simple procedure called Ischemic Conditioning (IC) for people recovering from a stroke. The hope is that IC could improve walking speed by enhancing the recruitment of motoneurons and resulting in positive neural adaptations.

Who is the study for?

This trial is for individuals aged 18-85 who are at least one year post-diagnosis of a unilateral, cortical stroke and still have weakness in their lower limbs. They must be able to consent to the study and walk slower than what's expected for their age and sex.Check my eligibility

What is being tested?

The study tests Ischemic Conditioning (IC), a non-invasive procedure thought to improve motor function, exercise performance, and cardiovascular health. Participants will undergo IC alongside treadmill training compared with those receiving a sham treatment.See study design

What are the potential side effects?

While specific side effects aren't listed, IC is generally considered low-risk. Potential side effects may include discomfort during the procedure or temporary changes in skin sensation where the conditioning is applied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a stroke over a year ago and still have weakness in my leg.

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I walk slower than others my age and gender.

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I am between 18 and 85 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 4 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 4 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 4 weeks. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Self Selected Walking Speed

Secondary outcome measures

Flow Mediated Dilation of Non-Paretic Brachial Artery and Paretic Popliteal Artery

Knee Extensor Fatigability

Knee Extensor Leg Strength

+1 more

Other outcome measures

Ankle

Bipolar Surface Electromyography (EMG) Measurements

Ground Reaction Force

+11 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Ischemic Conditioning + Treadmill TrainingExperimental Treatment2 Interventions

Study participants with prior history of stroke will receive both ischemic conditioning and treadmill training.

Group II: Ischemic Conditioning OnlyActive Control1 Intervention

Study participants with prior history of stroke will receive only ischemic conditioning.

Group III: Healthy Control - Ischemic Conditioning + Treadmill TrainingActive Control2 Interventions

Healthy control participants will receive both ischemic conditioning and treadmill training.

Group IV: Ischemic Conditioning Sham + Treadmill TrainingPlacebo Group2 Interventions

Study participants with prior history of stroke will receive both ischemic conditioning sham and treadmill training.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Treadmill Training

2009

Completed Phase 1

~140

Ischemic Conditioning

2019

N/A

~90

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Marquette UniversityOTHER

62 Previous Clinical Trials

200,203 Total Patients Enrolled

7 Trials studying Stroke

212 Patients Enrolled for Stroke

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,463 Total Patients Enrolled

17 Trials studying Stroke

1,310 Patients Enrolled for Stroke

Media Library

Ischemic Conditioning Clinical Trial Eligibility Overview. Trial Name: NCT04038697 — N/A

Stroke Research Study Groups: Ischemic Conditioning + Treadmill Training, Ischemic Conditioning Sham + Treadmill Training, Ischemic Conditioning Only, Healthy Control - Ischemic Conditioning + Treadmill Training

Stroke Clinical Trial 2023: Ischemic Conditioning Highlights & Side Effects. Trial Name: NCT04038697 — N/A

Ischemic Conditioning 2023 Treatment Timeline for Medical Study. Trial Name: NCT04038697 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people still eligible to register for this experiment?

"Correct. Clinicaltrials.gov data demonstrate that this research trial, which was initiated on December 20th 2018, is actively recruiting participants. Two medical centres are looking for a total of 120 patients to join the study."

Answered by AI

Is it feasible to include elderly individuals in this clinical trial?

"In line with the trial's requirements, volunteers must fit within a certain age range: 18 to 85 years old."

Answered by AI

How many individuals are enrolled in this clinical trial?

"Affirmative. Clinical trials.gov data shows that this clinical trial, first posted on December 20th 2018, is still recruiting participants. Around 120 individuals are needed at 2 different medical sites."

Answered by AI

What criteria must potential participants meet in order to take part in this trial?

"This clinical trial requires 120 participants that have experienced a unilateral hemorrhagic stroke within the past year and between 18 to 85 years of age, in addition to having residual lower extremity paresis. Candidates must also walk slower than is typical for their demographic."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ischemic Conditioning Improves Walking Function Post Stroke

Matthew J. Durand 2018. "Ischemic Conditioning Improves Walking Function Post Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04038697.

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