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

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06637839
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 95 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 31, 2026
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Berg Balance Scale (BBS) Score [ Time Frame: Discharge Assessment (Day 13-14) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

Find similar trials in New York, NY

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
NYU Langone Health· New York, NY

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