StrokeNCT02858349
Mechanisms of Walking Recovery After Stroke
A study testing High-intensity interval training in people with Stroke, run by University of Cincinnati at 1 site in United States.
Trial summary
Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention. Read more about this study
- Who is it for?
- Ages 30 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- High-intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 30-90 years
- unilateral stroke experienced >6 months prior to enrollment in middle cerebral artery (MCA) territory without complete disruption of the putamen on the lesion side
- walking speed <= 1.0 m/s on the 10 meter walk test
- able to walk 10m over ground with assistive devices as needed and no physical assistance
Who cannot join
- MRI incompatibility (e.g. metallic or electronic implants, severe claustrophobia)
- inability to perform mental imagery (time dependent motor imagery screening test [TDMI])
- evidence of significant arrhythmia or myocardial ischemia on treadmill ECG stress test, or significant baseline ECG abnormalities that would make an exercise ECG uninterpretable
- recent (<3 months) cardiopulmonary hospitalization
- unable to communicate with investigators or correctly answer consent comprehension questions
- significant ataxia or neglect (score of 2 on NIH stroke scale item 7 or 11)
Show all 13Show fewer
- severe lower extremity (LE) spasticity (Ashworth >2)
- recent (<3 months) illicit drug or alcohol abuse or significant mental illness
- major post-stroke depression (PHQ-9 ≥10) in the absence of medical management
- participating in physical therapy or another interventional research study;
- recent (<3 months) paretic LE botulinum toxin injection
- concurrent progressive neurologic disorder or other major medical, orthopedic or peripheral vascular conditions that would limit improvement
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention.
Read the detailed description
Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention using high-intensity interval training.
- Conditions
- Stroke
- Being tested
- No intervention, High-intensity interval training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionBehavioural
No intervention
High-intensity interval trainingBehavioural
High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | 4-week control period with no intervention and 4-weeks of high-intensity interval training Receives: Behavioral: No intervention; Behavioral: High-intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Speed
10-meter walk test
Measured: Change from 4-weeks to 8-weeks
Secondary outcomes (11)
Gait Symmetry
Paretic step ratio
Measured: baseline, 4 weeks, 8 weeks
Metabolic Cost of Gait
oxygen consumption rate during comfortable speed gait
Measured: baseline, 4 weeks, 8 weeks
Aerobic Capacity
oxygen consumption rate during exercise testing
Measured: baseline, 4 weeks, 8 weeks
NIH Toolbox - Cognition Domain
Measured: baseline, 4 weeks, 8 weeks
NIH Toolbox Standing Balance Test
Measured: baseline, 4 weeks, 8 weeks
Stroke and Aphasia Quality of Life Scale
Measured: baseline, 4 weeks, 8 weeks
Brain Locomotor Network Activation
Measured: baseline, 4 weeks, 8 weeks
Brain Locomotor Network Connectivity
Measured: baseline, 4 weeks, 8 weeks
Walking Capacity
6-minute walk test
Measured: baseline, 4 weeks, 8 weeks
Daily Walking Activity
activity monitor
Measured: baseline, 4 weeks, 8 weeks
Walking Speed
10-meter walk test
Measured: baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierce Boyne, University of Cincinnati
- Investigators
- Pierce Boyne, PT, DPT, NCS, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858349
- Sponsor's protocol ID
- 2016-1916
- Status last verified
- Nov 2018
- First submitted
- 29 Jul 2016
- Last updated
- 15 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Foster J, Awosika OO, Boyne P. Longitudinal Changes in the Cortico-Reticulospinal Tract Associated with High-Intensity Locomotor Training in Chronic Stroke. Neurorehabil Neural Repair. 2026 Nov 1:15459683261493916. doi: 10.1177/15459683261493916. Online ahead of print.
PubMed 42968579Foster J, Awosika OO, Boyne P. Role of Contralesional Corticoreticulospinal Tract Compensation in Walking Function After Stroke. Brain Behav. 2026 Jun;16(6):e71500. doi: 10.1002/brb3.71500.
PubMed 42204918Foster J, Awosika OO, Boyne P. Longitudinal changes in the cortico-reticulospinal tract associated with high-intensity locomotor training in chronic stroke. medRxiv [Preprint]. 2026 May 15:2026.05.12.26353042. doi: 10.64898/2026.05.12.26353042.
PubMed 42180339
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Walking Recovery After Stroke
- ClinicalTrials.gov ID
- NCT02858349
- Acronym / sponsor ID
- 2016-1916
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Posted 15 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention.
Detailed description
Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week control period and a 4-week exercise intervention using high-intensity interval training.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: No intervention, Behavioral: High-intensity interval training4-week control period with no intervention and 4-weeks of high-intensity interval training |
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 30-90 years
- unilateral stroke experienced >6 months prior to enrollment in middle cerebral artery (MCA) territory without complete disruption of the putamen on the lesion side
- walking speed <= 1.0 m/s on the 10 meter walk test
- able to walk 10m over ground with assistive devices as needed and no physical assistance
Key exclusion criteria (13 listed)
- MRI incompatibility (e.g. metallic or electronic implants, severe claustrophobia)
- inability to perform mental imagery (time dependent motor imagery screening test [TDMI])
- evidence of significant arrhythmia or myocardial ischemia on treadmill ECG stress test, or significant baseline ECG abnormalities that would make an exercise ECG uninterpretable
- recent (<3 months) cardiopulmonary hospitalization
- unable to communicate with investigators or correctly answer consent comprehension questions
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 |
|---|---|---|
| No interventionNo intervention | Behavioural | Arm 1 |
| High-intensity interval trainingHigh-intensity walking exercise using bursts of concentrated effort alternated with recovery periods | Behavioural | Arm 1 |
Primary outcome
Walking Speed
Time frame: Change from 4-weeks to 8-weeks
10-meter walk test
11 secondary outcomes
Gait Symmetry
Time frame: baseline, 4 weeks, 8 weeks
Metabolic Cost of Gait
Time frame: baseline, 4 weeks, 8 weeks
Aerobic Capacity
Time frame: baseline, 4 weeks, 8 weeks
NIH Toolbox - Cognition Domain
Time frame: baseline, 4 weeks, 8 weeks
NIH Toolbox Standing Balance Test
Time frame: baseline, 4 weeks, 8 weeks
Stroke and Aphasia Quality of Life Scale
Time frame: baseline, 4 weeks, 8 weeks
Brain Locomotor Network Activation
Time frame: baseline, 4 weeks, 8 weeks
Brain Locomotor Network Connectivity
Time frame: baseline, 4 weeks, 8 weeks
Walking Capacity
Time frame: baseline, 4 weeks, 8 weeks
Daily Walking Activity
Time frame: baseline, 4 weeks, 8 weeks
Walking Speed
Time frame: baseline, 4 weeks, 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42968579Foster J, Awosika OO, Boyne P. Longitudinal Changes in the Cortico-Reticulospinal Tract Associated with High-Intensity Locomotor Training in Chronic Stroke. Neurorehabil Neural Repair. 2026 Nov 1:15459683261493916. doi: 10.1177/15459683261493916. Online ahead of print.
- Derived from this study: PubMed 42204918Foster J, Awosika OO, Boyne P. Role of Contralesional Corticoreticulospinal Tract Compensation in Walking Function After Stroke. Brain Behav. 2026 Jun;16(6):e71500. doi: 10.1002/brb3.71500.
- Derived from this study: PubMed 42180339Foster J, Awosika OO, Boyne P. Longitudinal changes in the cortico-reticulospinal tract associated with high-intensity locomotor training in chronic stroke. medRxiv [Preprint]. 2026 May 15:2026.05.12.26353042. doi: 10.64898/2026.05.12.26353042.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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. This study is not recruiting at the moment.
Pierce Boyne, PT, DPT, NCS principal investigator
University of Cincinnati
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 interval training in people with Stroke, run by University of Cincinnati 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 15 Mar 2019. 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?
Yes. Results are posted in the registry (first posted 15 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Speed (time frame: Change from 4-weeks to 8-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 NCT02858349, which also lists 3 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 15 Mar 2019.