Blood Flow Restricted High-Intensity Treadmill Training on Independently Ambulating Chronic Ischemic CVA Survivors

NCT ID: NCT06214494

Last Updated: 2024-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke, Ischemic Ambulation Disorder, Neurologic Chronic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Randomized Case Control Cohort Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional Cohort

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

Group Type EXPERIMENTAL

Blood Flow Restricted High Intensity Treadmill Training

Intervention Type OTHER

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

Control Cohort

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

Group Type ACTIVE_COMPARATOR

HITT

Intervention Type OTHER

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

Interventions

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Blood Flow Restricted High Intensity Treadmill Training

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

Intervention Type OTHER

HITT

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

Intervention Type OTHER

Other Intervention Names

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BFR-HITT

Eligibility Criteria

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Inclusion Criteria

* Adults 18 years or older with history of single ischemic stroke \>6months.
* Ambulate without physical assistance over 10M with or without mobility aides and bracing in 180 seconds or less.

Exclusion Criteria

* Concurrent physical or occupational therapy.
* Vulnerable populations such as adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners will be excluded.
* Resting BP \>160/100mmHg even with medication.
* People who have taken analgesics, dopamine, antipyretics, and any other drugs that can affect the function of the autonomic nervous system in the last 2 weeks and likely to be treated with such drugs during the course of the study.
* Individuals who score 9 (greater than normal or minimal impairment) or more on the Short Blessed Cognitive Assessment (6 item) will be unable to give informed consent.
* Any medical condition (including heart failure, unstable angina, aortic stenosis, arrhythmias, hypertrophic cardiomyopathy, depression of ST-segment, previous or active deep vein thrombosis (DVT) in the hemiparetic lower extremity, pulmonary embolism (PE), bypass surgery within last 3 months.) that, in the opinion of the investigator, might jeopardize the participants' safety.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedStar National Rehabilitation Network

OTHER

Sponsor Role lead

Responsible Party

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Jane Alkhazov

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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MedStar National Rehabilitation Hospital

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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BFR-HITT

Identifier Type: -

Identifier Source: org_study_id

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