Cerebral Vascular Accident
Conditions
Keywords
High Intensity Gait Training, Inpatient Rehabilitation, Health Care Burden
Brief summary
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.
Interventions
Physical therapy intervention for improving gait in patients post Cerebral Vascular Accident.
OTHERConventional Therapy
Standard inpatient rehabilitation physical therapy treatments for Cerebral Vascular Accident.
Sponsors
Sunnyview Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* adults (≥18 years) recovering from a unilateral cerebral infarct with resultant hemiparesis occurring less than three months prior. Patients must have an expected length of stay of at least 14 days.
Exclusion criteria
* are older than 85 years of age have evidence of intracranial hemorrhage on head imaging * have had a brainstem, cerebellar or bilateral hemisphere stroke * are medically unstable * are pregnant * have chronic cardiorespiratory disease * on oxygen * angina * unstable arrhythmias * ischemic cardiomyopathy (Ejection Fraction \<50%) * unable to follow 2 steps commands accurately * neurological comorbidities that affect gait * Parkinson's * severe polyneuropathy * unable to walk at least 150 feet premorbid * dependent assistance level for transfer from a chair to a bed as assessed by physical therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost of inpatient rehabilitation and post-discharge health care services | (Day 62 to Day 86) - (Day 1 to Day 3) | This will include the cost of home health care, outpatient therapies, subacute nursing facility and hospital readmissions |
| 10 Meter Walk Test at Fast Speed | (Day 13-15) - (Day 1-3) | 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.. |
| 6 Minute Walk Test | (Day 13-15) - (Day 1-3) | Used to assess walking endurance and aerobic capacity. The total distance the patient walks over six minutes is recorded. |
| Stroke Impact Scale (SIS) | (Day 62 to Day 86)-(Day 14 to Day 21) | 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. |
| Life Space Assessment (LSA) | (Day 62 to Day 86)-(Day 14 to Day 21) | The LSA is a self report tool that measures frequency of independent mobility using 9 questions. |
| 10 Meter Walk Test at Self Selected Speed | (Day 13-15) - (Day 1-3) | Used to assess walking speed over a short distance at the patient's chosen speed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5 Times Sit to Stand | (Day 13-15) - (Day 1-3) | Measures functional lower extremity strength and movement patterns used to complete functional movements |
| Functional Ambulation Category (FAC) | (Day 13-15) - (Day 1-3) | A five point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking. |
| Assistive Device Use | (Day 13-15) - (Day 1-3) | Document which (if any) assistive device the patient uses for ambulation. |
| BERG Balance Scale | (Day 13-15) - (Day 1-3) | A 14 item scale used to assess sitting, standing, static and dynamic balance. |
Countries
United States
Outcome results
None listed