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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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.

United States1 site

University of Cincinnati
Cincinnati, Ohio, 45267

Other trials in United States

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 groups in NCT02858349
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.

Jul 2016Dec 2017

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)

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 42968579
Foster 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 42204918
Foster 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Stroke trials

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

Results posted to the registry on 15 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1	10	10

Primary outcome: Walking Speed

Time frame: Change from 4-weeks to 8-weeks. Least squares mean (95% Confidence Interval). Unit: meters per second

Measure	Arm 1 n = 10
Value	0.13 (0.05 to 0.21)

Arm 1: Mean Difference (Net): 0.13 (95% CI 0.05 to 0.21), p = 0.0042, Mixed Models Analysis

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout study participation, which lasted approximately 4 months for each participant. The entire study lasted approximately 17 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1	0 of 10 (0%)	8 of 10 (80%)	0 of 10

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.