Evaluating walking rehabilitation methods for stroke recovery
Variable Intensive Early Walking Post-Stroke -2 (VIEWS-2)
This study tests different walking rehabilitation methods to see which ones help stroke patients improve their walking ability and quality of life after their stroke.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT05727930 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of different rehabilitation interventions on walking ability and quality of life in patients who are 1 to 6 months post-stroke. It focuses on the intensity and specificity of exercise training, comparing high-intensity and low-intensity approaches, both task-specific and non-specific. The goal is to determine how these variables impact long-term mobility outcomes and to address gaps in current rehabilitation practices. By systematically assessing these factors, the study aims to enhance recovery strategies for stroke patients.
Who should consider this trial
Good fit: Ideal candidates are individuals who have experienced a sub-acute stroke within the last 1 to 6 months and have hemiparesis.
Not a fit: Patients with significant cardiovascular, metabolic, or respiratory diseases that limit their ability to participate in exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation protocols that enhance mobility and quality of life for stroke survivors.
How similar studies have performed: While some studies have explored similar rehabilitation approaches in chronic stroke patients, this specific focus on subacute stroke and the combined effects of intensity and specificity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Indianapolis, Indiana
- Rehabilitation Hospital of Indiana — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: George Hornby — Indiana University
- Study coordinator: George Hornby
- Email: tghornby@iu.edu
- Phone: 317-329-2353
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.