Clinical trial NCT06214494: Blood Flow Restricted High-Intensity Treadmill Training on Independently Ambulating Chronic Ischemic CVA Survivors
Official title: Effects of Blood Flow Restricted High Intensity Treadmill Training on Independently Ambulating Chronic Ischemic CVA Survivors: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke, Ischemic
Ambulation Disorder, Neurologic
Chronic Stroke
Keywords: Blood Flow Restriction Training
BFR
BFRt
High Intensity Treadmill Training
Lead sponsor: MedStar National Rehabilitation Network
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Case Control Cohort Study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 6 Minute Walk Test
timeFrame: Baseline, Week 4 (up to one week), Week 8( up to one week)
Secondary outcomes:
measure: 10 Meter Walk Test
timeFrame: Baseline, Week 4 (up to one week), Week 8( up to one week)
measure: 5 Time Sit to Stand
timeFrame: Baseline, Week 4 (up to one week), Week 8( up to one week)
measure: Functional Gait Assessment
timeFrame: Baseline, Week 4 (up to one week), Week 8( up to one week)
measure: BERG Balance Scale
timeFrame: Baseline, Week 4 (up to one week), Week 8( up to one week)
measure: Activities Balance Confidence Scale-16
timeFrame: Baseline, Week 4 (up to one week), Week 8( up to one week)
Other outcomes:
measure: Lower Extremity Limb Circumference
timeFrame: Baseline, Week 4 (up to one week), Week 8( up to one week)
measure: 1 Repetition Maximum Strength Testing (Leg press)
timeFrame: Baseline, Week 4 (up to one week), Week 8( up to one week)
measure: 1 Repetition Maximum Strength Testing (Knee Extension)
timeFrame: Baseline, Week 4 (up to one week), Week 8( up to one week)
Locations:
city: Washington
country: United States
facility: MedStar National Rehabilitation Hospital
state: District of Columbia
Study officials:
References: