High vs Low-frequency of High-intensity Training in Chronic Stroke (F-ITT)

January 26, 2026 updated by: George Hornby, Indiana University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will utilize a 2 arm randomized trial to investigate potential differences in locomotor and community outcomes following 18 visits of high-intensity gait training provided over 6 weeks (high frequency) or 12 weeks (low frequency). Following confirmation of eligibility and baseline testing, individuals will be randomized to either high or low frequency of training and complete subsequent testing at 6 weeks, 12 weeks, and 24 weeks.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Christopher Henderson, PhD
  • Phone Number: 317-329-2353
  • Email: henderce@iu.edu

Study Contact Backup

  • Name: Thomas G Hornby, PhD
  • Phone Number: 317-329-2353
  • Email: tghornby@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • Recruiting
        • Rehabilitation Hospital of Indiana
        • Contact:
        • Principal Investigator:
          • Christopher Henderson, PhD
        • Sub-Investigator:
          • Thomas G Hornby, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High frequency
Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 6 weeks
Other: high-intensity gait training
Individuals will perform up to 40 minutes of walking practice during 60 minute sessions while targeting heart rates of at least 70% heart rate reserve.
Behavioral: Physical activity coaching
Individuals will receive feedback on the minutes of walking activity performed on non-training days and provided coaching strategies to increase this metric.
Active Comparator: Low frequency
Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 12 weeks
Other: high-intensity gait training
Individuals will perform up to 40 minutes of walking practice during 60 minute sessions while targeting heart rates of at least 70% heart rate reserve.
Behavioral: Physical activity coaching
Individuals will receive feedback on the minutes of walking activity performed on non-training days and provided coaching strategies to increase this metric.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6-minute walk test
Time Frame: After 12 weeks
Individuals will be asked to "cover as much ground as possible" over 6 mins. Heart rate will additionally be measured during this assessment (distance in m)
After 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak treadmill speed
Time Frame: After 12 weeks
Individuals will participate in a walking-based graded exercise test. While harnessed for safety, a motorized treadmill will be initially set to 0.1 m/s and increased by 0.1 m/s each minute until the test is terminated due: 1) requests to stop, 2) unable to keep up with the treadmill and/or loses their balance, 3) absolute exercise test termination criteria provided by ACSM. The highest speed that the individual can walk for a minute at is the peak treadmill speed.
After 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Gait Assessment
Time Frame: After 12 weeks
10 item assessment of dynamic balance. Example tasks include walking with head turns, with eyes closed, and walking backwards.
After 12 weeks
30 second Sit to Stand Test
Time Frame: After 12 weeks
Participants will be asked to rise from a chair without using their arms and then return to sitting as many times as possible in 30 seconds.
After 12 weeks
Activity-Specific Balance Confidence (ABC) Scale
Time Frame: After 12 weeks
This questionnaire asks individuals to rate their balance-confidence from 0 (no confidence) to 100 (completely confident) during a variety of 16 commonly performed tasks such as walking around a house or getting into a car.
After 12 weeks
Oxygen Consumption
Time Frame: After 12 weeks
Oxygen consumption will be measured via a portable metabolic cart (K5; COSMED) during the previously described graded exercise test. Participant will wear a snug fitting mask that covers their mouth and nose, but does not affect the amount or quality of air that they breathe. The mask will be connected to a small backpack that collects information on the rate of breathing and oxygen consumed.
After 12 weeks
Medical Outcomes Survey Short-Form 36 (SF-36)
Time Frame: After 12 weeks
This 36-question survey asks individuals about how their current health may limit their ability to perform typical physical and social activities.
After 12 weeks
Steps per Day
Time Frame: After 12 weeks
Participants will wear a research-grade pedometer (StepWatch; Modus Health) during waking hours for ~1-2 weeks before beginning the training protocol, during the intervention period, and after completing training protocol to quantify home and community mobility. Participants will also be asked to document their daily minutes walked for exercise, number of walking bouts, where they performed the activity, and subjectively how hard they were working while walking for exercise.
After 12 weeks
Gait speed
Time Frame: After 12 weeks
This is an assessment of overground walking speed measured across a distance of ~20 feet and will be conducted at both self-selected (instructions: "walk at your usual, comfortable pace") and fastest (instructions: "walk as fast as you safely can") walking speeds on a pressure sensitive mat (speed in m/s; Zeno Walkway).
After 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Thomas G Hornby, PhD, Indiana University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 22, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24114

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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