Stroke is a major cause of disability, with 2-3% of Americans reporting stroke related impairments (Tsao 2022). Following stroke, over half of Medicare patients are discharged to post-acute care facilities or receive home-based health care (Tsao 2022). Inpatient rehabilitation guidelines are lacking, with many interventions based on research of patients with chronic stroke. There is great need for randomized clinical trials during the early subacute period (Bernhardt 2017, Jordan 2021). Clinical practice guidelines recommend high intensity gait training (HIGT) for ambulatory patients with chronic stroke (Hornby 2020). Outpatient HIGT protocols incorporating variable stepping demonstrate equivalent effectiveness to forward stepping protocols (Hornby 2019) and have yielded superior results to lower intensity therapies (Hornby 2019, Hornby 2016). Research suggests that HIGT with variable stepping is feasible during inpatient rehabilitation (Hornby 2015, Moore 2020). Pre-post studies suggest that participation in HIGT during inpatient rehabilitation yields greater improvements in walking without an increase in adverse events. (Moore 2020). Despite this, there are no randomized controlled trials evaluating HIGT in the inpatient setting. The subacute phase of stroke recovery may be a critical time for neuroplasticity (Dromerick 2021). Not only might rehabilitation interventions be more effective when initiated earlier (Biernaskie 2004, Dromerick 2021) but because inpatient rehabilitation represents the transition from hospital to home, interventions during this timeframe have the potential to improve discharge disposition, enhance quality of life, and reduce utilization of post-discharge services. In this randomized controlled study, investigators will determine how participation in HIGT during inpatient rehabilitation affects balance, ambulation, and quality of life after 14 and/or 21 days of inpatient rehabilitation, and 8 weeks post-discharge. Investigators will also determine if HIGT reduces health care burden with a cost-effectiveness analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Physical therapy intervention for improving gait in patients post Cerebral Vascular Accident.
Standard inpatient rehabilitation physical therapy treatments for Cerebral Vascular Accident.
Sunnyview Rehabilitation Hospital
Schenectady, New York, United States
10 Meter Walk Test at Self Selected Speed
Used to assess walking speed over a short distance at the patient's chosen speed.
Time frame: (Day 13-15) - (Day 1-3)
10 Meter Walk Test at Self Selected Speed
Used to assess walking speed over a short distance at the patient's chosen speed.
Time frame: (Day 20-22)- (Day 1-3)
10 Meter Walk Test at Self Selected Speed
Used to assess walking speed over a short distance at the patient's chosen speed.
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
10 Meter Walk Test at Fast Speed
Used to assess walking speed over a short distance at the patient's self determined speed that is as fast as they can safely walk..
Time frame: (Day 13-15) - (Day 1-3)
10 Meter Walk Test at Fast Speed
Used to assess walking speed over a short distance at the patient's self determined speed that is as fast as they can safely walk..
Time frame: (Day 20-22) - (Day 1-3)
10 Meter Walk Test at Fast Speed
Used to assess walking speed over a short distance at the patient's self determined speed that is as fast as they can safely walk..
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
6 Minute Walk Test
Used to assess walking endurance and aerobic capacity. The total distance the patient walks over six minutes is recorded.
Time frame: (Day 13-15) - (Day 1-3)
6 Minute Walk Test
Used to assess walking endurance and aerobic capacity. The total distance the patient walks over six minutes is recorded.
Time frame: (Day 20-22) - (Day 1-3)
6 Minute Walk Test
Used to assess walking endurance and aerobic capacity. The total distance the patient walks over six minutes is recorded.
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
Stroke Impact Scale (SIS)
The Stroke Impact Scale (SIS) is a self report questionnaire that uses 9 categories to assess disability and quality of life after having had a stroke.
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
Life Space Assessment (LSA)
The LSA is a self report tool that measures frequency of independent mobility using 9 questions.
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
Cost of inpatient rehabilitation and post-discharge health care services
This will include the cost of home health care, outpatient therapies, subacute nursing facility and hospital readmissions
Time frame: (Day 62 to Day 86) - (Day 1 to Day 3)
BERG Balance Scale
A 14 item scale used to assess sitting, standing, static and dynamic balance.
Time frame: (Day 13-15) - (Day 1-3)
BERG Balance Scale
A 14 item scale used to assess sitting, standing, static and dynamic balance.
Time frame: (Day 20-22) - (Day 1-3)
BERG Balance Scale
A 14 item scale used to assess sitting, standing, static and dynamic balance.
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
5 Times Sit to Stand
Measures functional lower extremity strength and movement patterns used to complete functional movements
Time frame: (Day 13-15) - (Day 1-3)
5 Times Sit to Stand
Measures functional lower extremity strength and movement patterns used to complete functional movements
Time frame: (Day 20-22) - (Day 1-3)
5 Times Sit to Stand
Measures functional lower extremity strength and movement patterns used to complete functional movements
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
Functional Ambulation Category (FAC)
A five point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking.
Time frame: (Day 13-15) - (Day 1-3)
Functional Ambulation Category (FAC)
A five point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking.
Time frame: (Day 20-22) - (Day 1-3)
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Functional Ambulation Category (FAC)
A five point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking.
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)
Assistive Device Use
Document which (if any) assistive device the patient uses for ambulation.
Time frame: (Day 13-15) - (Day 1-3)
Assistive Device Use
Document which (if any) assistive device the patient uses for ambulation.
Time frame: (Day 20-22) - (Day 1-3)
Assistive Device Use
Document which (if any) assistive device the patient uses for ambulation.
Time frame: (Day 62 to Day 86)-(Day 14 to Day 21)