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

Not Applicable

Not yet recruiting

• Conditions: Stroke

• Registration Number: NCT06637839
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11
• Study Start: 2025-04
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 131

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale (BBS) Score	Discharge Assessment (Day 13-14)	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.
Ten Meter Walk Test (10mWT) Time	Discharge Assessment (Day 13-14)	The 10mWT is an assessment of walking speed in meters per second over a distance of 10 meters.
Six Minute Walk Test (6MWT) Distance	Discharge Assessment (Day 13-14)	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.
Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI) - Admission Quality Indicator (QI) Score: Transfers	Discharge Assessment (Day 13-14)	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.
IRF-PAI - Admission QI Score: Cumulative Ambulation	Discharge Assessment (Day 13-14)	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.
IRF-PAI - Admission QI Score: Cumulative Stairs	Discharge Assessment (Day 13-14)	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.

Secondary Outcome Measures

Name	Time	Method
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)	Measurement of adherence to protocols.
Time Spent in Locomotor Training	Discharge Assessment (Day 13-14)	Measurement of adherence to protocols.
Number of Minutes Spent in Target HR Zone	Discharge Assessment (Day 13-14)	Measurement of adherence to protocols.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States