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

NCT06637839 | Not Yet Recruiting

• 1 other identifier: 24-00889
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. Investigators will randomize patients to receive one of two distinct HIGT interventions or a high step count intervention during standard care.

Conditions

Stroke

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Discharge Assessment (Day 13-14)

Secondary Outcomes (5)

• Number of Patients Discharged at Home

  Discharge Assessment (Day 13-14)

• Number of Patients Discharged at Subacute Rehabilitation Facility

  Discharge Assessment (Day 13-14)

• Number of Steps of Locomotor Training

  Discharge Assessment (Day 13-14)

• Time Spent in Locomotor Training

  Discharge Assessment (Day 13-14)

• Number of Minutes Spent in Target HR Zone

  Discharge Assessment (Day 13-14)

Study Arms (3)

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.

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.

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.

Behavioral: High-Step Count Locomotor Training Program

Interventions

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.

Moderate-Intensity Locomotor Training Program

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-Intensity Locomotor Training Program

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.

High-Step Count Locomotor Training Program

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary diagnosis of stroke

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Susan Camillieri

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan Camillieri

CONTACT

212-598-6044; Susan.camillieri@nyulangone.org

Melissa Chung

CONTACT

646-654-3519; Melissa.chung@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to susan.camillieri@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.

Locations

US (1)