StrokeVIEWS-2NCT05727930
Variable Intensive Early Walking Post-Stroke - 2 (VIEWS-2)
A study testing High-intensity, task-specific (i.e., walking) interventions, High-intensity, non-specific physical therapy interventions and Low-intensity, task-specific physical therapy interventions in people with Stroke, run by Indiana University at 1 site in United States.
Trial summary
The proposed research will evaluate the individual and combined effects of task-specificity and intensity of rehabilitation interventions on locomotor function, community mobility and quality of life in patients with subacute (1-6 months) post-stroke. 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, task-specific (i.e., walking) interventions, High-intensity, non-specific physical therapy interventions and Low-intensity, task-specific physical therapy interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2023to 15 Oct 2028
- 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
- Sub-acute stroke (1-6 months)
- Hemiparesis (Fugl-Meyer <34) without cerebellar deficits
- Ability to ambulate with or without physical assistance over 10 meters but < 1.0 m/s and assistive devices and below-knee bracing is allowed.
- Ability to sit > 30 seconds without upper-extremity support or physical assistance
- Ability to follow 3-step commands
- Provision of informed consent and medical clearance from a supervising physician or medical provider to participate
- Must have the ability to consent or have a legal health care power of attorney or legally authorized representative to consent for participation on their behalf
Who cannot join
- Significant cardiovascular, metabolic, or respiratory disease that limits exercise participation (e.g. previous myocardial infarction < 3 months prior, uncompensated congestive heart failure, resting blood pressure > 210/110 mmHg, uncontrolled diabetes, end-stage renal disease, severe infectious or psychiatry disease, or advanced malignancy)
- If during the graded-treadmill exercise evaluation, the participant presents with absolute criteria for termination of exercise testing during initial testing (e.g. moderate to severe angina, ST elevation > 1.0mm without preexisting Q wave secondary to prior MI, signs of poor perfusion, etc).
- Any orthopedic or neurological disorders that limited walking to <50m prior to stroke onset.
- Cannot receive physical therapy once baseline testing begins
- If patients are prescribed botulinum toxin for their lower extremities will be excluded only if the dosage for any specific muscle is >50 units in leg muscles above the knee. If doses are > than 50 units in leg muscles below the knee, the participant will use an ankle-foot orthosis to minimze contributions of those mscles to locomotor function.
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
George Hornby, 317-329-2353, tghornby@iu.edu
About this study
Official title: Variable Intensive Early Walking Post-Stroke -2 (VIEWS-2)
The proposed research will evaluate the individual and combined effects of task-specificity and intensity of rehabilitation interventions on locomotor function, community mobility and quality of life in patients with subacute (1-6 months) post-stroke.
Read the detailed description
The objective of this Phase II clinical trial is to identify how exercise training parameters, particularly the specificity and intensity of stepping practice, influence long-term mobility outcomes in patients with subacute stroke. Previous work indicates these variables can influence the efficacy of training interventions in individuals without neurological injury, with some data to support their utility in chronic stroke. However, studies that systematically assess the independent and combined effects of these principles in individuals early following stroke are sparse. This critical research gap impedes clinical translation, and current clinical practices remain adherent to traditional theories of rehabilitation, including lower intensity interventions focused on underlying impairments. Additional concerns of providing only high-intensity walking training revolve around the lack of attention toward movement quality will result in use of compensatory movement strategies that could be reinforced with repeated practice, or that other risks of cardiovascular events should preclude high-intensity training. Unfortunately, there is little data to support these hypotheses, and our studies suggest that application of these training parameters can strongly influence walking function, as well as improve underlying impairments and improve gait kinematics. Our approach is to characterize the effects of these training variables on recovery of locomotor function and quality, as well as changes in impairments and other mobility tasks in patients early post-stroke, in an effort to evaluate whether such training influences neurological recovery or whether patients utilize compensatory strategies. In this 2x2 factorial RCT design, Aim 1 of the study will characterize changes in mobility function associated with manipulation of specific and intensity of exercise interventions. We will evaluate functional measures of gait speed and endurance, spatiotemporal symmetry, as well as measures of cardiopulmonary fitness. We postulate that combined application of high-intensity, task specific stepping practice will result in significantly greater increases in locomotor measures as compared to lower intensity or non-specific training paradigms. In Aim 2, we will characterize the changes in impairments (strength) and other mobility tasks (balance, sit-to-stand transfers) to determine whether stepping intervention can mitigate the major impairments underlying post-stroke impairments. Quantitative measures of volitional strength will be the primary outcomes. In Aim 3, we will characterize changes in community mobility and quality of life, the later of which can inform us about cost-effectiveness. Overall, these results have potential implications on the delivery of effective exercise interventions in person with subacute stroke.
- Conditions
- Stroke
- Being tested
- High-intensity, task-specific (i.e., walking) interventions, High-intensity, non-specific physical therapy interventions, Low-intensity, task-specific physical therapy interventions, Low-intensity, non-specific physical therapy interventions
- Keywords
- acute, walking deficits
- 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, task-specific (i.e., walking) interventionsBehavioural
Up to 30 1-hr sessions of training focused on walking trying to achieve higher cardiovascular intensities
High-intensity, non-specific physical therapy interventionsBehavioural
Up to 30 1-hr sessions of training focused on varied physical interventions trying to achieve higher cardiovascular intensities
Low-intensity, task-specific physical therapy interventionsBehavioural
Up to 30 1-hr sessions of training focused on walking trying to achieve lower cardiovascular intensities
Low-intensity, non-specific physical therapy interventionsBehavioural
Up to 30 1-hr sessions of training focused on varied physical interventions trying to achieve lower cardiovascular intensities
| Study group | Role | What they receive |
|---|---|---|
| High-intensity, task-specific (i.e., walking) interventions | Experimental | 30 1-hour (hr) sessions of walking training targeting higher cardiovascular intensities over approximately 2 months Receives: Behavioral: High-intensity, task-specific (i.e., walking) interventions |
| High-intensity, non-specific physical therapy interventions | Active comparator | 30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting higher cardiovascular intensities over approximately 2 months Receives: Behavioral: High-intensity, non-specific physical therapy interventions |
| Low-intensity, task-specific physical therapy interventions | Active comparator | 30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting lower cardiovascular intensities over approximately 2 months Receives: Behavioral: Low-intensity, task-specific physical therapy interventions |
| Low-intensity, non-specific physical therapy interventions | Active comparator | 30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting lower cardiovascular intensities over approximately 2 months Receives: Behavioral: Low-intensity, non-specific physical therapy interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 6 minute walk test
Changes in 6 min walk test from baseline to post-training
Measured: Approximately 8-10 weeks
Secondary outcomes (6)
Changes in community mobility
Changes in daily stepping (steps/day) from baseline to post-training
Measured: Approximately 8-10 weeks
Changes in measures of physical participation
Changes in Medical Outcomes Short Form -36 questions from baseline to post-training
Measured: Approximately 8-10 weeks
Changes in gait biomechanics
Changes in gait biomechanics (spatiotemporal and joint kinematics and kinetics) from baseline to post-training
Measured: Approximately 8-10 weeks
Changes in peak metabolic capacity (VO2peak) during peak treadmill speed
Changes in peak metabolic capacity (VO2peak) during peak treadmill speed from baseline to post-training
Measured: Approximately 8-10 weeks
Changes in peak treadmill speed during the graded-exercise test
Changes in peak treadmill speed during the graded-exercise test from baseline to post-testing
Measured: Approximately 8-10 weeks
Changes in gait speed
Changes in gait speed over 6 m from baseline to post-training
Measured: Approximately 8-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start11 Jan 2023
- Primary completion15 Oct 2028 (estimated)
- Study completion15 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Factorial
- Model description
- 2X2 factorial design with primary independent variables of specificity of practice and intensity of practice during physical rehabilitation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, George Hornby, Indiana University
- Investigators
- George Hornby, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727930
- Sponsor's protocol ID
- IU-16767
- Other IDs
- 1R01HD108622
- Acronym
- VIEWS-2
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently Undecided
Publications
Holleran CL, Straube DD, Kinnaird CR, Leddy AL, Hornby TG. Feasibility and potential efficacy of high-intensity stepping training in variable contexts in subacute and chronic stroke. Neurorehabil Neural Repair. 2014 Sep;28(7):643-51. doi: 10.1177/1545968314521001. Epub 2014 Feb 10.
PubMed 24515925Hornby TG, Holleran CL, Hennessy PW, Leddy AL, Connolly M, Camardo J, Woodward J, Mahtani G, Lovell L, Roth EJ. Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2016 Jun;30(5):440-50. doi: 10.1177/1545968315604396. Epub 2015 Sep 3.
PubMed 26338433Leddy AL, Connolly M, Holleran CL, Hennessy PW, Woodward J, Arena RA, Roth EJ, Hornby TG. Alterations in Aerobic Exercise Performance and Gait Economy Following High-Intensity Dynamic Stepping Training in Persons With Subacute Stroke. J Neurol Phys Ther. 2016 Oct;40(4):239-48. doi: 10.1097/NPT.0000000000000147.
PubMed 27632078Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.
PubMed 31434543Moore JL, Roth EJ, Killian C, Hornby TG. Locomotor training improves daily stepping activity and gait efficiency in individuals poststroke who have reached a "plateau" in recovery. Stroke. 2010 Jan;41(1):129-35. doi: 10.1161/STROKEAHA.109.563247. Epub 2009 Nov 12.
PubMed 19910547Lotter JK, Henderson CE, Plawecki A, Holthus ME, Lucas EH, Ardestani MM, Schmit BD, Hornby TG. Task-Specific Versus Impairment-Based Training on Locomotor Performance in Individuals With Chronic Spinal Cord Injury: A Randomized Crossover Study. Neurorehabil Neural Repair. 2020 Jul;34(7):627-639. doi: 10.1177/1545968320927384. Epub 2020 Jun 1.
PubMed 32476619Straube DD, Holleran CL, Kinnaird CR, Leddy AL, Hennessy PW, Hornby TG. Effects of dynamic stepping training on nonlocomotor tasks in individuals poststroke. Phys Ther. 2014 Jul;94(7):921-33. doi: 10.2522/ptj.20130544. Epub 2014 Mar 13.
PubMed 24627428Moore JL, Nordvik JE, Erichsen A, Rosseland I, Bo E, Hornby TG; FIRST-Oslo Team. Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes. Stroke. 2020 Feb;51(2):563-570. doi: 10.1161/STROKEAHA.119.027450. Epub 2019 Dec 30.
PubMed 31884902Boyne P, Dunning K, Carl D, Gerson M, Khoury J, Rockwell B, Keeton G, Westover J, Williams A, McCarthy M, Kissela B. High-Intensity Interval Training and Moderate-Intensity Continuous Training in Ambulatory Chronic Stroke: Feasibility Study. Phys Ther. 2016 Oct;96(10):1533-1544. doi: 10.2522/ptj.20150277. Epub 2016 Apr 21.
PubMed 27103222
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variable Intensive Early Walking Post-Stroke -2 (VIEWS-2)
- ClinicalTrials.gov ID
- NCT05727930
- Acronym / sponsor ID
- VIEWS-2 / IU-16767
- Conditions
- Stroke
- Keywords
- acute, walking deficits
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Northwestern University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 15 Oct 2028 (estimated)
- Study completion
- 15 Oct 2028 (estimated)
- First posted
- 14 Feb 2023 (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 proposed research will evaluate the individual and combined effects of task-specificity and intensity of rehabilitation interventions on locomotor function, community mobility and quality of life in patients with subacute (1-6 months) post-stroke.
Detailed description
The objective of this Phase II clinical trial is to identify how exercise training parameters, particularly the specificity and intensity of stepping practice, influence long-term mobility outcomes in patients with subacute stroke. Previous work indicates these variables can influence the efficacy of training interventions in individuals without neurological injury, with some data to support their utility in chronic stroke. However, studies that systematically assess the independent and combined effects of these principles in individuals early following stroke are sparse. This critical research gap impedes clinical translation, and current clinical practices remain adherent to traditional theories of rehabilitation, including lower intensity interventions focused on underlying impairments. Additional concerns of providing only high-intensity walking training revolve around the lack of attention toward movement quality will result in use of compensatory movement strategies that could be reinforced with repeated practice, or that other risks of cardiovascular events should preclude high-intensity training. Unfortunately, there is little data to support these hypotheses, and our studies suggest that application of these training parameters can strongly influence walking function, as well as improve underlying impairments and improve gait kinematics. Our approach is to characterize the effects of these training variables on recovery of locomotor function and quality, as well as changes in impairments and other mobility tasks in patients early post-stroke, in an effort to evaluate whether such training influences neurological recovery or whether patients utilize compensatory strategies. In this 2x2 factorial RCT design, Aim 1 of the study will characterize changes in mobility function associated with manipulation of specific and intensity of exercise interventions. We will evaluate functional measures of gait speed and endurance, spatiotemporal symmetry, as well as measures of cardiopulmonary fitness. We postulate that combined application of high-intensity, task specific stepping practice will result in significantly greater increases in locomotor measures as compared to lower intensity or non-specific training paradigms. In Aim 2, we will characterize the changes in impairments (strength) and other mobility tasks (balance, sit-to-stand transfers) to determine whether stepping intervention can mitigate the major impairments underlying post-stroke impairments. Quantitative measures of volitional strength will be the primary outcomes. In Aim 3, we will characterize changes in community mobility and quality of life, the later of which can inform us about cost-effectiveness. Overall, these results have potential implications on the delivery of effective exercise interventions in person with subacute stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 2X2 factorial design with primary independent variables of specificity of practice and intensity of practice during physical rehabilitation.
| Arm | Type | Receives |
|---|---|---|
| High-intensity, task-specific (i.e., walking) interventions | Experimental | Behavioral: High-intensity, task-specific (i.e., walking) interventions30 1-hour (hr) sessions of walking training targeting higher cardiovascular intensities over approximately 2 months |
| High-intensity, non-specific physical therapy interventions | Active comparator | Behavioral: High-intensity, non-specific physical therapy interventions30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting higher cardiovascular intensities over approximately 2 months |
| Low-intensity, task-specific physical therapy interventions | Active comparator | Behavioral: Low-intensity, task-specific physical therapy interventions30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting lower cardiovascular intensities over approximately 2 months |
| Low-intensity, non-specific physical therapy interventions | Active comparator | Behavioral: Low-intensity, non-specific physical therapy interventions30 1-hr sessions of general physical therapy interventions (strengthening, balance training, aerobic cycling, transfers, walking) targeting lower cardiovascular intensities over approximately 2 months |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Sub-acute stroke (1-6 months)
- Hemiparesis (Fugl-Meyer <34) without cerebellar deficits
- Ability to ambulate with or without physical assistance over 10 meters but < 1.0 m/s and assistive devices and below-knee bracing is allowed.
- Ability to sit > 30 seconds without upper-extremity support or physical assistance
- Ability to follow 3-step commands
Key exclusion criteria (5 listed)
- Significant cardiovascular, metabolic, or respiratory disease that limits exercise participation (e.g. previous myocardial infarction < 3 months prior, uncompensated congestive heart failure, resting blood pressure > 210/110 mmHg, uncontrolled diabetes, end-stage renal disease, severe infectious or psychiatry disease, or advanced malignancy)
- If during the graded-treadmill exercise evaluation, the participant presents with absolute criteria for termination of exercise testing during initial testing (e.g. moderate to severe angina, ST elevation > 1.0mm without preexisting Q wave secondary to prior MI, signs of poor perfusion, etc).
- Any orthopedic or neurological disorders that limited walking to <50m prior to stroke onset.
- Cannot receive physical therapy once baseline testing begins
- If patients are prescribed botulinum toxin for their lower extremities will be excluded only if the dosage for any specific muscle is >50 units in leg muscles above the knee. If doses are > than 50 units in leg muscles below the knee, the participant will use an ankle-foot orthosis to minimze contributions of those mscles to locomotor function.
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, task-specific (i.e., walking) interventionsUp to 30 1-hr sessions of training focused on walking trying to achieve higher cardiovascular intensities | Behavioural | High-intensity, task-specific (i.e., walking) interventions |
| High-intensity, non-specific physical therapy interventionsUp to 30 1-hr sessions of training focused on varied physical interventions trying to achieve higher cardiovascular intensities | Behavioural | High-intensity, non-specific physical therapy interventions |
| Low-intensity, task-specific physical therapy interventionsUp to 30 1-hr sessions of training focused on walking trying to achieve lower cardiovascular intensities | Behavioural | Low-intensity, task-specific physical therapy interventions |
| Low-intensity, non-specific physical therapy interventionsUp to 30 1-hr sessions of training focused on varied physical interventions trying to achieve lower cardiovascular intensities | Behavioural | Low-intensity, non-specific physical therapy interventions |
Primary outcome
Changes in 6 minute walk test
Time frame: Approximately 8-10 weeks
Changes in 6 min walk test from baseline to post-training
6 secondary outcomes
Changes in community mobility
Time frame: Approximately 8-10 weeks
Changes in measures of physical participation
Time frame: Approximately 8-10 weeks
Changes in gait biomechanics
Time frame: Approximately 8-10 weeks
Changes in peak metabolic capacity (VO2peak) during peak treadmill speed
Time frame: Approximately 8-10 weeks
Changes in peak treadmill speed during the graded-exercise test
Time frame: Approximately 8-10 weeks
Changes in gait speed
Time frame: Approximately 8-10 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 Mar 2026.
- Background: PubMed 24515925Holleran CL, Straube DD, Kinnaird CR, Leddy AL, Hornby TG. Feasibility and potential efficacy of high-intensity stepping training in variable contexts in subacute and chronic stroke. Neurorehabil Neural Repair. 2014 Sep;28(7):643-51. doi: 10.1177/1545968314521001. Epub 2014 Feb 10.
- Background: PubMed 26338433Hornby TG, Holleran CL, Hennessy PW, Leddy AL, Connolly M, Camardo J, Woodward J, Mahtani G, Lovell L, Roth EJ. Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2016 Jun;30(5):440-50. doi: 10.1177/1545968315604396. Epub 2015 Sep 3.
- Background: PubMed 27632078Leddy AL, Connolly M, Holleran CL, Hennessy PW, Woodward J, Arena RA, Roth EJ, Hornby TG. Alterations in Aerobic Exercise Performance and Gait Economy Following High-Intensity Dynamic Stepping Training in Persons With Subacute Stroke. J Neurol Phys Ther. 2016 Oct;40(4):239-48. doi: 10.1097/NPT.0000000000000147.
- Background: PubMed 31434543Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.
- Background: PubMed 19910547Moore JL, Roth EJ, Killian C, Hornby TG. Locomotor training improves daily stepping activity and gait efficiency in individuals poststroke who have reached a "plateau" in recovery. Stroke. 2010 Jan;41(1):129-35. doi: 10.1161/STROKEAHA.109.563247. Epub 2009 Nov 12.
- Background: PubMed 32476619Lotter JK, Henderson CE, Plawecki A, Holthus ME, Lucas EH, Ardestani MM, Schmit BD, Hornby TG. Task-Specific Versus Impairment-Based Training on Locomotor Performance in Individuals With Chronic Spinal Cord Injury: A Randomized Crossover Study. Neurorehabil Neural Repair. 2020 Jul;34(7):627-639. doi: 10.1177/1545968320927384. Epub 2020 Jun 1.
- Background: PubMed 24627428Straube DD, Holleran CL, Kinnaird CR, Leddy AL, Hennessy PW, Hornby TG. Effects of dynamic stepping training on nonlocomotor tasks in individuals poststroke. Phys Ther. 2014 Jul;94(7):921-33. doi: 10.2522/ptj.20130544. Epub 2014 Mar 13.
- Background: PubMed 31884902Moore JL, Nordvik JE, Erichsen A, Rosseland I, Bo E, Hornby TG; FIRST-Oslo Team. Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes. Stroke. 2020 Feb;51(2):563-570. doi: 10.1161/STROKEAHA.119.027450. Epub 2019 Dec 30.
- Background: PubMed 27103222Boyne P, Dunning K, Carl D, Gerson M, Khoury J, Rockwell B, Keeton G, Westover J, Williams A, McCarthy M, Kissela B. High-Intensity Interval Training and Moderate-Intensity Continuous Training in Ambulatory Chronic Stroke: Feasibility Study. Phys Ther. 2016 Oct;96(10):1533-1544. doi: 10.2522/ptj.20150277. Epub 2016 Apr 21.
- Individual participant dataSharing planned: Undecided. Currently Undecided
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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.
George Hornby 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, task-specific (i.e., walking) interventions, High-intensity, non-specific physical therapy interventions and Low-intensity, task-specific physical therapy interventions 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 5 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 Mar 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 George Hornby (317-329-2353, tghornby@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 6 minute walk test (time frame: Approximately 8-10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05727930, which also lists 9 linked publications.
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 Mar 2026.