Effects of Blood Flow Restricted High Intensity Treadmill Training on Independently Ambulating Chronic Ischemic CVA Survivors: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- 6 Minute Walk Test
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Blood Flow Restricted High Intensity Treadmill Training (Other)
Control Cohort
High-Intensity Treadmill Training 2x weekly for 16 Sessions totaling a minimum of 75minutes weekly.
Intervention: HITT (Other)
Outcomes
Primary Outcomes
6 Minute Walk Test
Time Frame: Baseline, Week 4 (up to one week), Week 8( up to one week)
The 6-minute walk test (6MWT) assesses distance walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance.
Secondary Outcomes
- Activities Balance Confidence Scale-16(Baseline, Week 4 (up to one week), Week 8( up to one week))
- 5 Time Sit to Stand(Baseline, Week 4 (up to one week), Week 8( up to one week))
- Functional Gait Assessment(Baseline, Week 4 (up to one week), Week 8( up to one week))
- 10 Meter Walk Test(Baseline, Week 4 (up to one week), Week 8( up to one week))
- BERG Balance Scale(Baseline, Week 4 (up to one week), Week 8( up to one week))
Investigators
Jane Alkhazov
Principal Investigator
MedStar National Rehabilitation Network