About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Parallel
Treatments tested in this trial
Moderate-Intensity Locomotor Training Program
BehavioralThe 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
BehavioralThe 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
BehavioralThe high step count program prescribes at least 600 steps per session, at less than 50% or HR reserve, or less than 13 RPE.
Treatment groups
Trial outcomes
Primary outcomes
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.
Ten Meter Walk Test (10mWT) Time
The 10mWT is an assessment of walking speed in meters per second over a distance of 10 meters.
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.
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.
Secondary outcomes
Number of Patients Discharged at Home
Number of Patients Discharged at Subacute Rehabilitation Facility
Number of Steps of Locomotor Training
Measurement of adherence to protocols.
Time Spent in Locomotor Training
Measurement of adherence to protocols.
Sponsors and contacts
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NYU Langone Health
Lead sponsor
National Institutes of Health (NIH)
Collaborator
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