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New treatment option for Stroke
Official title HIT-Stroke Trial 2
ClinicalTrials.gov ID: NCT06268041
What this study is testing
- What it's testing
- People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 85
You may be able to join if
- Age 30-85 years at time of consenting
- Hemiparesis from ischemic and/or hemorrhagic strokes
- Most recent stroke for which participant sought treatment, at least 6 months prior to study consent
- Walking speed \<1.0 m/s on the 10-meter walk test
- Able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent...
You likely can't join if
- Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no...
- Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive...
- Hospitalization for cardiac or pulmonary disease within past 3 months
- Implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit
- Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
- Severe lower limb spasticity (Ashworth \>2)
See the full eligibility criteria
- Age 30-85 years at time of consenting
- Hemiparesis from ischemic and/or hemorrhagic strokes
- Most recent stroke for which participant sought treatment, at least 6 months prior to study consent
- Walking speed \<1.0 m/s on the 10-meter walk test
- Able to walk 10m over ground with assistive devices as needed and no continuous physical assistance from another person (guarding and intermittent assistance for loss of balance allowed)
- Able to walk at least 3 minutes on the treadmill at ≥0.13m/s (0.3 mph)
- Stable cardiovascular condition (AHA class B, allowing for aerobic capacity \<6 metabolic equivalents)
- Able to communicate with investigators, follow a 2-step command and correctly answer consent comprehension questions
- Exercise testing uninterpretable for ischemia or arrhythmia (e.g. resting ECG abnormality that makes exercise ECG uninterpretable for ischemia and no other clinical testing from the past year available to rule out these...
- Evidence of significant arrhythmia or myocardial ischemia on treadmill ECG graded exercise test in the absence of recent (past year) more definitive clinical testing (e.g. stress nuclear imaging) with negative result
- Hospitalization for cardiac or pulmonary disease within past 3 months
- Implanted pacemaker or defibrillator with an upper heart rate limit that would interfere with exercise testing or prescription, or with unknown limit
- Significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
- Severe lower limb spasticity (Ashworth \>2)
- Known recent history (\<3 months) of unstable substance abuse or unstable mental illness
- Major post-stroke depression (Patient Health Questionnaire [PHQ-9] ≥ 10) in the absence of depression management by a health care provider
- Currently participating in physical therapy or another treatment study targeting walking function
- Recent (\<2 weeks) or planned changes in lower limb orthotic or spasticity management
- Foot drop or lower limb joint instability without adequate stabilizing device, as assessed by a physical therapist
- Clinically significant neurologic disorder other than stroke or unable to walk outside the home prior to stroke
- Unable to walk outside the home prior to stroke
- Other significant medical condition likely to limit improvement or jeopardize safety as assessed by a physical therapist (e.g. joint contracture, gait limited by pain)
- Pregnancy
- Previous exposure to fast treadmill walking (\>3 cumulative hours) in the past year
The study team makes the final eligibility decision.
Where it's taking place
- Newark, Delaware, United States
- Kansas City, Kansas, United States
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newark, Delaware, United States; Kansas City, Kansas, United States; Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.