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NCT05650606
Inpatient Rehabilitation and Post-Discharge Outcomes With High Intensity Gait Training (HIGT) of Patients With Stroke
Conditions: Cerebral Vascular Accident
Sex: All
Ages: 18 Years – 85 Years
Phase: NA
Enrollment: 144
Sponsor: Sunnyview Rehabilitation Hospital
Location: United States
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.
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 imaginghave had a brainstem, cerebellar or bilateral hemisphere strokeare medically unstableare pregnanthave chronic cardiorespiratory diseaseon oxygenanginaunstable arrhythmiasischemic cardiomyopathy (Ejection Fraction <50%)unable to follow 2 steps commands accuratelyneurological comorbidities that affect gaitParkinson'ssevere polyneuropathyunable to walk at least 150 feet premorbiddependent assistance level for transfer from a chair to a bed as assessed by physical therapy.
Source: ClinicalTrials.gov (NCT05650606). StuddyBuddy aggregates publicly available trial information.