High-Intensity Treadmill Training for Stroke Survivors

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: MedStar National Rehabilitation Network

No Placebo Group

Trial Summary

What is the purpose of this trial?Individuals surviving Chronic Ischemic Stroke have lingering walking deficits long after their infarct. The main goal of this study is to compare two high intensity treadmill walking programs to see which improves walking more. The main question we aim to answer is: How does blood flow restricted high-intensity treadmill training impact walking function? Participants will be randomly separated into two groups. One group will perform the high intensity treadmill training with blood flow restriction on their Stroke affected leg, while the second group performs high intensity treadmill training only. Every week participants will be asked to walk on the treadmill for a total of 75 minutes during 2x 1-hour sessions. On visit 1, participants will undergo strength, balance, and walking testing. They will then be treated 2x weekly for 4 weeks (visit 2-9) and be re-tested to track progress on visit 10. Participants will again be treated 2x weekly for 4 more weeks (visit 11-18) and be tested to see the end results on visit 19. Researchers will then compare both groups to see if blood flow restriction training changes walking function, strength, and balance.

Eligibility Criteria

This trial is for adults over 18 who had a stroke more than 6 months ago and can walk at least 10 meters unassisted or with aids/bracing in under 180 seconds. It's not suitable for those who cannot meet these walking requirements.

Inclusion Criteria

I can walk 10 meters by myself in less than 3 minutes, with or without help like a cane.

I am an adult over 18 and had a stroke more than 6 months ago.

Exclusion Criteria

Resting BP >160/100mmHg even with medication

Individuals scoring 9 or more on the Short Blessed Cognitive Assessment

Presence of specific medical conditions that might jeopardize participant safety

+3 more

Participant Groups

The study compares two high-intensity treadmill training programs to see which one better improves walking abilities in chronic ischemic stroke survivors. One group will use blood flow restriction on the affected leg, while the other won't.

2Treatment groups

Experimental Treatment

Active Control

Group I: Interventional CohortExperimental Treatment1 Intervention

Blood Flow Restricted High Intensity Treadmill Training at 70% limb occlusion 2x weekly for 16 Sessions totaling a minimum of 75 minutes weekly.

Group II: Control CohortActive Control1 Intervention

High-Intensity Treadmill Training 2x weekly for 16 Sessions totaling a minimum of 75minutes weekly.