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

NCT ID: NCT06637839

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Moderate-Intensity Locomotor Training Program

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.

Group Type EXPERIMENTAL

Moderate-Intensity Locomotor Training Program

Intervention Type 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

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.

Group Type EXPERIMENTAL

High-Intensity Locomotor Training Program

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

High-Step Count Locomotor Training Program

Intervention Type 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.

Interventions

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Moderate-Intensity Locomotor Training Program

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.

Intervention Type BEHAVIORAL

High-Intensity Locomotor Training Program

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.

Intervention Type BEHAVIORAL

High-Step Count Locomotor Training Program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan Camillieri

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Central Contacts

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Susan Camillieri

Role: CONTACT

212-598-6044

Melissa Chung

Role: CONTACT

646-654-3519

Other Identifiers

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24-00889

Identifier Type: -

Identifier Source: org_study_id

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