StrokeNCT06637839
Optimal Dosing of High-Intensity Locomotor Training for Step Attainment and Locomotor Outcomes in Stroke Patients Undergoing Acute Inpatient Rehabilitation
A study testing Moderate-Intensity Locomotor Training Program, High-Intensity Locomotor Training Program and High-Step Count Locomotor Training Program in people with Stroke, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to elucidate optimal dosing for High Intensity Gait Training (HIGT) to reduce locomotor disability for those undergoing inpatient rehabilitation (IR) in the subacute phase of stroke recovery. This is a randomized controlled trial conducted at a single IR facility. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Stroke
- What is being tested?
- Moderate-Intensity Locomotor Training Program, High-Intensity Locomotor Training Program and High-Step Count Locomotor Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Dec 2027
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of stroke
Who cannot join
- Weightbearing restrictions, uncontrolled cardiopulmonary, metabolic, infectious, or psychiatric disorders, which would preclude aerobic locomotor training
- Estimated length of stay of less than 14 days
- Non-ambulatory status prior to admission (unable to walk >50 meters)
- Pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind Study Comparing the Effects of Three Distinct High Intensity Locomotor Training Protocols on Locomotor Outcomes in Subacute Stroke Patients Undergoing Adult Inpatient Rehabilitation.
The purpose of this study is to elucidate optimal dosing for High Intensity Gait Training (HIGT) to reduce locomotor disability for those undergoing inpatient rehabilitation (IR) in the subacute phase of stroke recovery.
This is a randomized controlled trial conducted at a single IR facility. Investigators will randomize patients to receive one of two distinct HIGT interventions or a high step count intervention during standard care.
- Conditions
- Stroke
- Being tested
- Moderate-Intensity Locomotor Training Program, High-Intensity Locomotor Training Program, High-Step Count Locomotor Training Program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Intensity Locomotor Training ProgramBehavioural
The moderate-intensity program prescribes participants to exert 50-59% of their heart rate (HR) reserve, or a score of 13-15 on Borg's rating of perceived exertion (RPE) scale.
High-Intensity Locomotor Training ProgramBehavioural
The high-intensity program prescribes participants to exert at least 60% of their heart rate (HR) reserve, or a score of 16-18 on the RPE scale.
High-Step Count Locomotor Training ProgramBehavioural
The high step count program prescribes at least 600 steps per session, at less than 50% or HR reserve, or less than 13 RPE.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-Intensity Locomotor Training Program | Experimental | Treatment will be administered for 10 consecutive 1-hour sessions over a 10-day period. Therapists will deliver the assigned intervention as part of standard care. Receives: Behavioral: Moderate-Intensity Locomotor Training Program |
| High-Intensity Locomotor Training Program | Experimental | Treatment will be administered for 10 consecutive 1-hour sessions over a 10-day period. Therapists will deliver the assigned intervention as part of standard care. Receives: Behavioral: High-Intensity Locomotor Training Program |
| High-Step Count Locomotor Training Program | Active comparator | Treatment will be administered for 10 consecutive 1-hour sessions over a 10-day period. Therapists will deliver the assigned intervention as part of standard care. Receives: Behavioral: High-Step Count Locomotor Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS) Score
The BBS is a 14-item objective assessment that static balance and fall risk in adults. Each item is rated on a scale from 0-4. The total score is the sum of responses and ranges from ranges from 0 to 56, with lower scores indicating a higher risk of falling and lower functional mobility.
Measured: Discharge Assessment (Day 13-14)
Ten Meter Walk Test (10mWT) Time
The 10mWT is an assessment of walking speed in meters per second over a distance of 10 meters.
Measured: Discharge Assessment (Day 13-14)
Six Minute Walk Test (6MWT) Distance
The 6MWT is a sub-maximal exercise test used to assess walking endurance and aerobic capacity. Participants walk around the perimeter of a set circuit for a total of six minutes. The measure is the total distance covered in six minutes.
Measured: Discharge Assessment (Day 13-14)
Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) - Admission Quality Indicator (QI) Score: Transfers
The IRF-PAI QI score is an ordinal categorical variable measuring how much assistance a patient requires to complete the task (transfer) There are six categories (1-6) ranging from complete dependence of the patient on a helper to independent completion of tasks. A score of 1 is assigned to dependent patients, while a score of 6 represents independent completion of tasks by a patient.
Measured: Discharge Assessment (Day 13-14)
IRF-PAI - Admission QI Score: Cumulative Ambulation
The IRF-PAI QI score is an ordinal categorical variable measuring how much assistance a patient requires to complete the task (ambulation) There are six categories (1-6) ranging from complete dependence of the patient on a helper to independent completion of tasks. A score of 1 is assigned to dependent patients, while a score of 6 represents independent completion of tasks by a patient.
Measured: Discharge Assessment (Day 13-14)
IRF-PAI - Admission QI Score: Cumulative Stairs
The IRF-PAI QI score is an ordinal categorical variable measuring how much assistance a patient requires to complete the task (stairs) There are six categories (1-6) ranging from complete dependence of the patient on a helper to independent completion of tasks. A score of 1 is assigned to dependent patients, while a score of 6 represents independent completion of tasks by a patient.
Measured: Discharge Assessment (Day 13-14)
Secondary outcomes (5)
Number of Patients Discharged at Home
Measured: Discharge Assessment (Day 13-14)
Number of Patients Discharged at Subacute Rehabilitation Facility
Measured: Discharge Assessment (Day 13-14)
Number of Steps of Locomotor Training
Measurement of adherence to protocols.
Measured: Discharge Assessment (Day 13-14)
Time Spent in Locomotor Training
Measurement of adherence to protocols.
Measured: Discharge Assessment (Day 13-14)
Number of Minutes Spent in Target HR Zone
Measurement of adherence to protocols.
Measured: Discharge Assessment (Day 13-14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study startJan 2027 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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 NYU Langone HealthThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Susan Camillieri, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637839
- Sponsor's protocol ID
- 24-00889
- Status last verified
- Jun 2026
- First submitted
- 10 Oct 2024
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: susan.camillieri@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study Comparing the Effects of Three Distinct High Intensity Locomotor Training Protocols on Locomotor Outcomes in Subacute Stroke Patients Undergoing Adult Inpatient Rehabilitation.
- ClinicalTrials.gov ID
- NCT06637839
- Acronym / sponsor ID
- 24-00889
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Oct 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 study is to elucidate optimal dosing for High Intensity Gait Training (HIGT) to reduce locomotor disability for those undergoing inpatient rehabilitation (IR) in the subacute phase of stroke recovery.
This is a randomized controlled trial conducted at a single IR facility. Investigators will randomize patients to receive one of two distinct HIGT interventions or a high step count intervention during standard care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moderate-Intensity Locomotor Training Program | Experimental | Behavioral: Moderate-Intensity Locomotor Training ProgramTreatment will be administered for 10 consecutive 1-hour sessions over a 10-day period. Therapists will deliver the assigned intervention as part of standard care. |
| High-Intensity Locomotor Training Program | Experimental | Behavioral: High-Intensity Locomotor Training ProgramTreatment will be administered for 10 consecutive 1-hour sessions over a 10-day period. Therapists will deliver the assigned intervention as part of standard care. |
| High-Step Count Locomotor Training Program | Active comparator | Behavioral: High-Step Count Locomotor Training ProgramTreatment will be administered for 10 consecutive 1-hour sessions over a 10-day period. Therapists will deliver the assigned intervention as part of standard care. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary diagnosis of stroke
Key exclusion criteria (4 listed)
- Weightbearing restrictions, uncontrolled cardiopulmonary, metabolic, infectious, or psychiatric disorders, which would preclude aerobic locomotor training
- Estimated length of stay of less than 14 days
- Non-ambulatory status prior to admission (unable to walk >50 meters)
- Pregnant
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 |
|---|---|---|
| Moderate-Intensity Locomotor Training ProgramThe moderate-intensity program prescribes participants to exert 50-59% of their heart rate (HR) reserve, or a score of 13-15 on Borg's rating of perceived exertion (RPE) scale. | Behavioural | Moderate-Intensity Locomotor Training Program |
| High-Intensity Locomotor Training ProgramThe high-intensity program prescribes participants to exert at least 60% of their heart rate (HR) reserve, or a score of 16-18 on the RPE scale. | Behavioural | High-Intensity Locomotor Training Program |
| High-Step Count Locomotor Training ProgramThe high step count program prescribes at least 600 steps per session, at less than 50% or HR reserve, or less than 13 RPE. | Behavioural | High-Step Count Locomotor Training Program |
Primary outcome
Berg Balance Scale (BBS) Score
Time frame: Discharge Assessment (Day 13-14)
The BBS is a 14-item objective assessment that static balance and fall risk in adults. Each item is rated on a scale from 0-4. The total score is the sum of responses and ranges from ranges from 0 to 56, with lower scores indicating a higher risk of falling and lower functional mobility.
Ten Meter Walk Test (10mWT) Time
Time frame: Discharge Assessment (Day 13-14)
The 10mWT is an assessment of walking speed in meters per second over a distance of 10 meters.
Six Minute Walk Test (6MWT) Distance
Time frame: Discharge Assessment (Day 13-14)
The 6MWT is a sub-maximal exercise test used to assess walking endurance and aerobic capacity. Participants walk around the perimeter of a set circuit for a total of six minutes. The measure is the total distance covered in six minutes.
Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) - Admission Quality Indicator (QI) Score: Transfers
Time frame: Discharge Assessment (Day 13-14)
The IRF-PAI QI score is an ordinal categorical variable measuring how much assistance a patient requires to complete the task (transfer) There are six categories (1-6) ranging from complete dependence of the patient on a helper to independent completion of tasks. A score of 1 is assigned to dependent patients, while a score of 6 represents independent completion of tasks by a patient.
IRF-PAI - Admission QI Score: Cumulative Ambulation
Time frame: Discharge Assessment (Day 13-14)
The IRF-PAI QI score is an ordinal categorical variable measuring how much assistance a patient requires to complete the task (ambulation) There are six categories (1-6) ranging from complete dependence of the patient on a helper to independent completion of tasks. A score of 1 is assigned to dependent patients, while a score of 6 represents independent completion of tasks by a patient.
IRF-PAI - Admission QI Score: Cumulative Stairs
Time frame: Discharge Assessment (Day 13-14)
The IRF-PAI QI score is an ordinal categorical variable measuring how much assistance a patient requires to complete the task (stairs) There are six categories (1-6) ranging from complete dependence of the patient on a helper to independent completion of tasks. A score of 1 is assigned to dependent patients, while a score of 6 represents independent completion of tasks by a patient.
5 secondary outcomes
Number of Patients Discharged at Home
Time frame: Discharge Assessment (Day 13-14)
Number of Patients Discharged at Subacute Rehabilitation Facility
Time frame: Discharge Assessment (Day 13-14)
Number of Steps of Locomotor Training
Time frame: Discharge Assessment (Day 13-14)
Time Spent in Locomotor Training
Time frame: Discharge Assessment (Day 13-14)
Number of Minutes Spent in Target HR Zone
Time frame: Discharge Assessment (Day 13-14)
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 26 Jun 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: susan.camillieri@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Susan Camillieri principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Intensity Locomotor Training Program, High-Intensity Locomotor Training Program and High-Step Count Locomotor Training Program in people with Stroke, run by NYU Langone Health 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 1 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: opening soon, as of the sponsor's last update on 26 Jun 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 Susan Camillieri (212-598-6044, Susan.camillieri@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (BBS) Score (time frame: Discharge Assessment (Day 13-14)). The study lists 6 primary outcomes in all. 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 26 Jun 2026.