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NCT Number: NCT06637839

Optimal Dosing of High-Intensity Locomotor Training for Step Attainment and Locomotor Outcomes in Stroke Patients Undergoing Acute 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary diagnosis of stroke

Exclusion criteria

  • 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

Treatment and study plan

Moderate-Intensity Locomotor Training Program

Behavioral

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 Program

Behavioral

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 Program

Behavioral

The high step count program prescribes at least 600 steps per session, at less than 50% or HR reserve, or less than 13 RPE.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Number of Patients Discharged at Home

    Time frame: Discharge Assessment (Day 13-14)

  2. Number of Patients Discharged at Subacute Rehabilitation Facility

    Time frame: Discharge Assessment (Day 13-14)

  3. Number of Steps of Locomotor Training

    Time frame: Discharge Assessment (Day 13-14)

    Measurement of adherence to protocols.

  4. Time Spent in Locomotor Training

    Time frame: Discharge Assessment (Day 13-14)

    Measurement of adherence to protocols.

  5. Number of Minutes Spent in Target HR Zone

    Time frame: Discharge Assessment (Day 13-14)

    Measurement of adherence to protocols.

Study contacts

Contact information is provided by the study sponsor or research team.

Melissa Chung

CONTACT

[email protected]

646-654-3519

Susan Camillieri

CONTACT

[email protected]

212-598-6044

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study 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.

Important dates

Study start
2027
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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