High vs Low-frequency of High-intensity Training in Chronic Stroke
Launched by INDIANA UNIVERSITY · Sep 22, 2024
Trial Information
Current as of March 11, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how often people with chronic stroke should participate in high-intensity training to improve their walking ability. The researchers want to see if training more frequently leads to better outcomes compared to training less often. The study is currently recruiting participants aged 18 to 85 who have had a stroke more than six months ago and have some difficulties with movement on one side of their body. To be eligible, participants should be able to walk with some assistance and follow simple commands.
If you or a loved one qualifies for this study, you will be asked to participate in a walking program that includes both supervised training sessions and exercises you can do at home. It’s important to note that certain medical conditions, previous injuries, or current participation in other physical therapies may prevent someone from joining this trial. Overall, this study aims to help improve walking skills in stroke survivors, which could potentially enhance their daily life and independence.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Unilateral deficits following stroke \> 6 months prior; however individuals \> 4 months post-stroke are eligible for consenting, but final eligibility and potential enrollment will not occur until \> 6 months
- • Age 18-85
- • Weight \< 350 pounds
- • Able to follow 3-step commands
- • Able to ambulate with self-selected gait speeds between 0.10-1.0 m/s without physical assistance, but with below knee bracing and/or assistive device as needed
- • Lower extremity Fugl-Meyer \< 34
- • Medical clearance to participate
- Exclusion Criteria:
- • Evidence of cerebellar ataxia
- • Uncontrolled cardiopulmonary or metabolic disease that limits exercise participation, active heterotopic ossification, recurrent history of lower extremity fractures, previous orthopedic or other peripheral or central neurologic injury that may impair locomotor activities such that, in the judgement of the PI, could compromise the safety of the participant, limit the ability to complete the study, or compromise the objectives of the study.
- • Currently participating in other physical therapy
- • \>50 units of Botox in the lower extremity OR in the lower extremity, but above the knee if the participant wears an ankle-foot-orthosis (AFO) within the past three months
Trial Officials
Thomas G Hornby, PhD
Principal Investigator
Indiana University
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Indianapolis, Indiana, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0