NCT05727930 Variable Intensive Early Walking Post-Stroke - 2 (VIEWS-2)
| NCT ID | NCT05727930 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-01-11 |
| Primary Completion | 2028-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-01-11 with a primary completion date of 2028-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
George Hornby
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT05727930 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05727930 currently recruiting?
Yes, NCT05727930 is actively recruiting participants. Contact the research team at tghornby@iu.edu for enrollment information.
Where is the NCT05727930 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT05727930 clinical trial?
NCT05727930 is sponsored by Indiana University. The principal investigator is George Hornby at Indiana University. The trial plans to enroll 100 participants.
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