Inpatient Rehabilitation and Post-Discharge Outcomes of Patients With Stroke Participating in High Intensity Gait Training
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Vascular Accident
- Sponsor
- Sunnyview Rehabilitation Hospital
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- 6 Minute Walk Test
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Patricia Broschart Valenza
Therapy Supervisor
Sunnyview Rehabilitation Hospital
Eligibility Criteria
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
- •unstable arrhythmias
- •ischemic cardiomyopathy (Ejection Fraction \<50%)
- •unable to follow 2 steps commands accurately
- •neurological comorbidities that affect gait
Outcomes
Primary Outcomes
6 Minute Walk Test
Time Frame: (Day 62 to Day 86)-(Day 14 to Day 21)
Used to assess walking endurance and aerobic capacity. The total distance the patient walks over six minutes is recorded.
Cost of inpatient rehabilitation and post-discharge health care services
Time Frame: (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 Self Selected Speed
Time Frame: (Day 62 to Day 86)-(Day 14 to Day 21)
Used to assess walking speed over a short distance at the patient's chosen speed.
10 Meter Walk Test at Fast Speed
Time Frame: (Day 62 to Day 86)-(Day 14 to Day 21)
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..
Stroke Impact Scale (SIS)
Time Frame: (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)
Time Frame: (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.
Secondary Outcomes
- Assistive Device Use((Day 62 to Day 86)-(Day 14 to Day 21))
- 5 Times Sit to Stand((Day 62 to Day 86)-(Day 14 to Day 21))
- Functional Ambulation Category (FAC)((Day 62 to Day 86)-(Day 14 to Day 21))
- BERG Balance Scale((Day 62 to Day 86)-(Day 14 to Day 21))