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

NYU Langone Health

Status: Not yet enrolling

Conditions: Stroke

Treatments: Behavioral: High-Step Count Locomotor Training Program; Behavioral: Moderate-Intensity Locomotor Training Program; Behavioral: High-Intensity Locomotor Training Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06637839

24-00889

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 3 patient groups

Moderate-Intensity Locomotor Training Program

Experimental group

Description:

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.

Treatment:

Behavioral: Moderate-Intensity Locomotor Training Program

High-Intensity Locomotor Training Program

Experimental group

Description:

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.

Treatment:

Behavioral: High-Intensity Locomotor Training Program

High-Step Count Locomotor Training Program

Active Comparator group

Description:

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.

Treatment:

Behavioral: High-Step Count Locomotor Training Program