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
- 1
- 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.
研究组 & 干预措施
Conventional
The conventional physical therapy sessions are what a patient would normally receive during their rehabilitation. Physical therapy sessions are usually 60-90 minutes per day for 5 days each week, and possibly one 30-minute session on a 6th day. Physical therapy sessions are focused on gait, balance, and strengthening activities to address goals related to functional mobility. Clinicians administering therapy to patients in this arm will not be given instructions on the types of therapies they administer; however, they will not be permitted to do HIGT with patients. Therapists will be permitted to use other devices such as Ekso exoskeleton, Lite Gait, Rifton Tram Body Weight Support Devices, and Electrical Stimulation devices including the XCITE and RT300.
干预措施: Conventional Therapy (Other)
High Intensity Gait Training
HIGT will be performed 4-6 times per week in place of conventional physical therapy. The patient's heart rate(HR)and blood pressure(BP) will be measured throughout each session. If the HR or BP is out of the acceptable range, patients will undergo standard physical therapy for that session, and the medical team will be contacted.
Target HR zones will be calculated with the Karvonen formula. The first session goal is to reach a target HR range that is 50-60% of heart rate reserve. The goal for subsequent sessions is to reach 70-80% of heart rate reserve. Rate of perceived exertion (RPE) will also be utilized.
The primary therapist will design an individualized HIGT treatment program with a combination of speed dependent treadmill activities, activity-based treadmill activities, stair training, and over ground activities.
The patient will be reminded during each session to ask for a rest as needed. Standing rests are preferred over sitting rests, but either may be utilized.
干预措施: High Intensity Gait Training (Other)
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.
10 Meter Walk Test at Self Selected Speed
时间窗: (Day 13-15) - (Day 1-3)
Used to assess walking speed over a short distance at the patient's chosen speed.
10 Meter Walk Test at Self Selected Speed
时间窗: (Day 20-22)- (Day 1-3)
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 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..
10 Meter Walk Test at Fast Speed
时间窗: (Day 20-22) - (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
时间窗: (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.
6 Minute Walk Test
时间窗: (Day 20-22) - (Day 1-3)
Used to assess walking endurance and aerobic capacity. The total distance the patient walks over six minutes is recorded.
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))
- 5 Times Sit to Stand((Day 13-15) - (Day 1-3))
- BERG Balance Scale((Day 13-15) - (Day 1-3))
- BERG Balance Scale((Day 20-22) - (Day 1-3))
- 5 Times Sit to Stand((Day 20-22) - (Day 1-3))
- Functional Ambulation Category (FAC)((Day 13-15) - (Day 1-3))
- Functional Ambulation Category (FAC)((Day 20-22) - (Day 1-3))
- Assistive Device Use((Day 13-15) - (Day 1-3))
- Assistive Device Use((Day 20-22) - (Day 1-3))
研究者
Patricia Broschart Valenza
Therapy Supervisor
Sunnyview Rehabilitation Hospital