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Recruiting
NCT05727930
Variable Intensive Early Walking Post-Stroke - 2 (VIEWS-2)
Conditions: Stroke
Sex: All
Ages: 18 Years – 85 Years
Phase: NA
Enrollment: 100
Sponsor: Indiana University
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Sub-acute stroke (1-6 months)Hemiparesis (Fugl-Meyer <34) without cerebellar deficitsAbility 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 assistanceAbility to follow 3-step commandsProvision of informed consent and medical clearance from a supervising physician or medical provider to participateMust have the ability to consent or have a legal health care power of attorney or legally authorized representative to consent for participation on their behalfExclusion 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 beginsIf 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.
Source: ClinicalTrials.gov (NCT05727930). StuddyBuddy aggregates publicly available trial information.