NCT06612723 High vs Low-frequency of High-intensity Training in Chronic Stroke
| NCT ID | NCT06612723 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2026-10 |
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 40 participants in total. It began in 2024-09-16 with a primary completion date of 2026-10.
⚠ 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 purpose of this pilot study is to investigate the potential role of training frequency on locomotor outcomes following high-intensity gait training and provision of a home walking program.
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
Contact & Investigator
Thomas G Hornby, PhD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT06612723 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 NCT06612723 currently recruiting?
Yes, NCT06612723 is actively recruiting participants. Contact the research team at henderce@iu.edu for enrollment information.
Where is the NCT06612723 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT06612723 clinical trial?
NCT06612723 is sponsored by Indiana University. The principal investigator is Thomas G Hornby, PhD at Indiana University. The trial plans to enroll 40 participants.
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