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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Berg Balance Scale (BBS) Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 95 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
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.
Intervention: Moderate-Intensity Locomotor Training Program (Behavioral)
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.
Intervention: High-Intensity Locomotor Training Program (Behavioral)
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.
Intervention: High-Step Count Locomotor Training Program (Behavioral)
Outcomes
Primary Outcomes
Berg Balance Scale (BBS) Score
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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))
- Time Spent in Locomotor Training(Discharge Assessment (Day 13-14))
- Number of Minutes Spent in Target HR Zone(Discharge Assessment (Day 13-14))