NCT05727930 · Indiana University
Variable Intensive Early Walking Post-Stroke - 2 (VIEWS-2)
(VIEWS-2)
What this study is about
The proposed research will evaluate the individual and combined effects of task-specificity and intensity of rehabilitation interventions on locomotor function, community mobility and quality of life in patients with subacute (1-6 months) post-stroke.
View original scientific description
The proposed research will evaluate the individual and combined effects of task-specificity and intensity of rehabilitation interventions on locomotor function, community mobility and quality of life in patients with subacute (1-6 months) post-stroke.
Interventions
BEHAVIORAL
High-intensity, task-specific (i.e., walking) interventions
Up to 30 1-hr sessions of training focused on walking trying to achieve higher cardiovascular intensities
BEHAVIORAL
High-intensity, non-specific physical therapy interventions
Up to 30 1-hr sessions of training focused on varied physical interventions trying to achieve higher cardiovascular intensities
BEHAVIORAL
Low-intensity, task-specific physical therapy interventions
Up to 30 1-hr sessions of training focused on walking trying to achieve lower cardiovascular intensities
BEHAVIORAL
Low-intensity, non-specific physical therapy interventions
Up to 30 1-hr sessions of training focused on varied physical interventions trying to achieve lower cardiovascular intensities
Primary outcome measures
Changes in 6 minute walk test
Time frame: Approximately 8-10 weeks
Changes in 6 min walk test from baseline to post-training
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Sub-acute stroke (1-6 months)
- Hemiparesis (Fugl-Meyer \<34) without cerebellar deficits
- Ability to ambulate with or without physical assistance over 10 meters but \< 1.0 m/s and assistive devices and below-knee bracing is allowed.
- Ability to sit \> 30 seconds without upper-extremity support or physical assistance
- Ability to follow 3-step commands
- Provision of informed consent and medical clearance from a supervising physician or medical provider to participate
- Must have the ability to consent or have a legal health care power of attorney or legally authorized representative to consent for participation on their behalf
Exclusion criteria
- Significant cardiovascular, metabolic, or respiratory disease that limits exercise participation (e.g. previous myocardial infarction \< 3 months prior, uncompensated congestive heart failure, resting blood pressure \> 210/110 mmHg, uncontrolled diabetes, end-stage renal disease, severe infectious or psychiatry disease, or advanced malignancy)
- If during the graded-treadmill exercise evaluation, the participant presents with absolute criteria for termination of exercise testing during initial testing (e.g. moderate to severe angina, ST elevation \> 1.0mm without preexisting Q wave secondary to prior MI, signs of poor perfusion, etc).
- Any orthopedic or neurological disorders that limited walking to \<50m prior to stroke onset.
- Cannot receive physical therapy once baseline testing begins
- If patients are prescribed botulinum toxin for their lower extremities will be excluded only if the dosage for any specific muscle is \>50 units in leg muscles above the knee. If doses are \> than 50 units in leg muscles below the knee, the participant will use an ankle-foot orthosis to minimze contributions of those mscles to locomotor function.
Where
- Indianapolis, Indiana
Collaborators
Northwestern University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 27, 2026 · Source of record for eligibility and locations