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Not yet recruiting NCT06637839

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

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Moderate-Intensity Locomotor Training Program, High-Intensity Locomotor Training Program, High-Step Count Locomotor Training Program.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 95 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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.

Overview

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.

Interventions

  • Behavioral 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.
  • 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.
  • 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.

Primary outcome measures

  • Berg Balance Scale (BBS) Score [Time frame: Discharge Assessment (Day 13-14)]
  • Ten Meter Walk Test (10mWT) Time [Time frame: Discharge Assessment (Day 13-14)]
  • Six Minute Walk Test (6MWT) Distance [Time frame: Discharge Assessment (Day 13-14)]
  • Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) - Admission Quality Indicator (QI) Score: Transfers [Time frame: Discharge Assessment (Day 13-14)]
  • IRF-PAI - Admission QI Score: Cumulative Ambulation [Time frame: Discharge Assessment (Day 13-14)]
  • IRF-PAI - Admission QI Score: Cumulative Stairs [Time frame: Discharge Assessment (Day 13-14)]
Secondary outcome measures (5)
  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT06637839 · 24-00889

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗