Stroke
Conditions
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.
Interventions
BEHAVIORALHigh-Step Count Locomotor Training Program
The high step count program prescribes at least 600 steps per session, at less than 50% or HR reserve, or less than 13 RPE.
BEHAVIORALModerate-Intensity Locomotor Training Program
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.
BEHAVIORALHigh-Intensity Locomotor Training Program
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.
Sponsors
NYU Langone Health
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
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) * Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTSusan Camillieri
CONTACTMelissa Chung
PRINCIPAL_INVESTIGATORSusan Camillieri
NYU Langone Health
Outcome results
None listed