Inpatient Rehabilitation and Post-Discharge Outcomes of Patients With Stroke Participating in High Intensity Gait Training
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- 6 Minute Walk Test
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
结局指标
主要结局
6 Minute Walk Test
时间窗: (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
时间窗: (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
时间窗: (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
时间窗: (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)
时间窗: (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)
时间窗: (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.
次要结局
- 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))
研究者
Patricia Broschart Valenza
Therapy Supervisor
Sunnyview Rehabilitation Hospital