StrokeF-ITTNCT06612723
High vs Low-frequency of High-intensity Training in Chronic Stroke
A study testing high-intensity gait training and Physical activity coaching in people with Stroke, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- high-intensity gait training and Physical activity coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254
Alicia Ward, MS, 317-329-2353, alicward@iu.edu
Christopher Henderson, PhD
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- high-intensity gait training, Physical activity coaching
- Keywords
- stroke, gait, rehabilitation, high-intensity, frequency
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensity gait trainingOther
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.
Physical activity coachingBehavioural
Individuals will receive feedback on the minutes of walking activity performed on non-training days and provided coaching strategies to increase this metric.
| Study group | Role | What they receive |
|---|---|---|
| High frequency | Experimental | Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 6 weeks Receives: Other: high-intensity gait training; Behavioral: Physical activity coaching |
| Low frequency | Active comparator | Individuals will receive up to 18 visits of high-intensity gait training and activity coaching over 12 weeks Receives: Other: high-intensity gait training; Behavioral: Physical activity coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
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)
Measured: After 12 weeks
Secondary outcomes (1)
Peak treadmill speed
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.
Measured: After 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start16 Sep 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, George Hornby, Indiana University
- Investigators
- Thomas G Hornby, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612723
- Sponsor's protocol ID
- 24114
- Acronym
- F-ITT
- Status last verified
- Jan 2026
- First submitted
- 20 Sep 2024
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High vs Low-frequency of High-intensity Training in Chronic Stroke
- ClinicalTrials.gov ID
- NCT06612723
- Acronym / sponsor ID
- F-ITT / 24114
- Conditions
- Stroke
- Keywords
- stroke, gait, rehabilitation, high-intensity, frequency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 25 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High frequency | Experimental | Other: high-intensity gait training, Behavioral: Physical activity coachingIndividuals will receive up to 18 visits of high-intensity gait training and activity coaching over 6 weeks |
| Low frequency | Active comparator | Other: high-intensity gait training, Behavioral: Physical activity coachingIndividuals will receive up to 18 visits of high-intensity gait training and activity coaching over 12 weeks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-intensity gait trainingIndividuals will perform up to 40 minutes of walking practice during 60 minute sessions while targeting heart rates of at least 70% heart rate reserve. | Other | High frequency, Low frequency |
| Physical activity coachingIndividuals will receive feedback on the minutes of walking activity performed on non-training days and provided coaching strategies to increase this metric. | Behavioural | High frequency, Low frequency |
Primary outcome
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)
1 secondary outcome
Peak treadmill speed
Time frame: After 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas G Hornby, PhD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-intensity gait training and Physical activity coaching in people with Stroke, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Henderson, PhD (317-329-2353, henderce@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (time frame: After 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.