Clinical trial Recruiting at 1 site Interventional Ages 18 to 85

Comparing high and low-frequency high-intensity training for stroke recovery

Official title: High vs Low-frequency of High-intensity Training in Chronic Stroke

Run by Indiana University · NCT06612723 · Data updated 2026-11-12

This study is testing whether more frequent high-intensity walking training helps people who have had a stroke recover their walking ability better than less frequent training.

Quick facts

Study typeInterventional
Ages18 Years to 85 Years
SexAll
Enrollment40 (estimated)
SponsorIndiana University
Academic / other
Locations1 site (Indianapolis, Indiana)
StatusRecruiting
StartedSeptember 16, 2024
Main results expectedOctober 2026
Study endsOctober 2026
Registry record updatedJanuary 27, 2026
Trial IDNCT06612723 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-85 who have experienced a unilateral stroke more than 6 months prior and can ambulate with some assistance.

Probably not a fit

Patients with uncontrolled cardiopulmonary or metabolic diseases, or those with significant neurological impairments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to explore how the frequency of high-intensity gait training affects locomotor outcomes in individuals who have experienced a stroke. Participants will be randomly assigned to either a high-frequency training group, receiving 18 sessions over 6 weeks, or a low-frequency group, receiving the same training over 12 weeks. The study will assess outcomes at 6, 12, and 24 weeks post-training to determine the effectiveness of each approach. The focus is on improving gait and overall community mobility through structured rehabilitation.

Why it matters

Potential benefit: If successful, this study could enhance rehabilitation strategies for stroke survivors, leading to improved mobility and quality of life.

How similar studies have gone: While similar studies have explored high-intensity training for stroke rehabilitation, this specific comparison of training frequency is novel.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Rehabilitation Hospital of Indiana
    Indianapolis, Indiana, United States
    Recruiting

Study contacts

  • Principal investigator: Thomas G Hornby, PhD — Indiana University
  • Study coordinator: Christopher Henderson, PhD
  • Email: henderce@iu.edu
  • Phone: 317-329-2353

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.