Trials
Search / Trial NCT06612723

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

Stroke Gait Rehabilitation High Intensity Frequency

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.

Locations

Indianapolis, Indiana, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0