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Search / Trial NCT05727930

Variable Intensive Early Walking Post-Stroke - 2 (VIEWS-2)

Launched by INDIANA UNIVERSITY · Feb 6, 2023

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

Acute Walking Deficits

ClinConnect Summary

The VIEWS-2 trial is a research study focusing on how different types of rehabilitation, specifically the intensity and task-specific practices, can help improve walking and overall mobility in people who have had a stroke. The study targets individuals who are in the subacute phase of recovery, meaning they are between one to six months post-stroke. The goal is to see how these rehabilitation methods can enhance their ability to walk, move around in their community, and improve their quality of life.

To join this study, participants should be aged between 65 and 74 years and have experienced a stroke that resulted in some weakness on one side of their body, but they should still be able to walk at least 10 meters with or without help. Participants will need to be able to sit independently for more than 30 seconds and follow simple commands. Those with severe heart, lung, or other health issues that might prevent them from exercising, or with certain neurological disorders that affected their walking ability before the stroke, will not be eligible. If selected, participants can expect to engage in physical therapy sessions focused on improving their walking skills and overall function while being closely monitored for safety.

Gender

ALL

Eligibility 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.

About Indiana University

Indiana University, a leading research institution, is committed to advancing healthcare through innovative clinical trials and rigorous scientific inquiry. With a focus on improving patient outcomes, the university conducts a wide range of studies across various medical disciplines, leveraging its extensive resources and collaborative networks. Indiana University's dedication to ethical research practices and community engagement ensures that its clinical trials not only contribute to scientific knowledge but also prioritize participant safety and well-being. Through its commitment to excellence, Indiana University plays a pivotal role in shaping the future of medicine and enhancing public health.

Locations

Indianapolis, Indiana, United States

Patients applied

0 patients applied

Trial Officials

George Hornby

Principal Investigator

Indiana University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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