Inpatient Rehabilitation and Post-Discharge Outcomes With High Intensity Gait Training (HIGT) of Patients With Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Inpatient Rehabilitation and Post-Discharge Outcomes of Patients With Stroke Participating in High Intensity Gait Training

Conditions
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Cerebral Vascular Accident

Intervention / Treatment
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* Other: High Intensity Gait Training
* Other: Conventional Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Gait Training<br>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. | Other: High Intensity Gait Training<br>* Physical therapy intervention for improving gait in patients post Cerebral Vascular Accident.<br>|
| Active Comparator: Conventional<br>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. | Other: Conventional Therapy<br>* Standard inpatient rehabilitation physical therapy treatments for Cerebral Vascular Accident.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 Meter Walk Test at Self Selected Speed | Used to assess walking speed over a short distance at the patient's chosen speed. | (Day 13-15) - (Day 1-3) | 
| 10 Meter Walk Test at Self Selected Speed | Used to assess walking speed over a short distance at the patient's chosen speed. | (Day 20-22)- (Day 1-3) | 
| 10 Meter Walk Test at Self Selected Speed | Used to assess walking speed over a short distance at the patient's chosen speed. | (Day 62 to Day 86)-(Day 14 to Day 21) | 
| 10 Meter Walk Test at Fast Speed | 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.. | (Day 13-15) - (Day 1-3) | 
| 10 Meter Walk Test at Fast Speed | 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.. | (Day 20-22) - (Day 1-3) | 
| 10 Meter Walk Test at Fast Speed | 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.. | (Day 62 to Day 86)-(Day 14 to Day 21) | 
| 6 Minute Walk Test | Used to assess walking endurance and aerobic capacity. The total distance the patient walks over six minutes is recorded. | (Day 13-15) - (Day 1-3) | 
| 6 Minute Walk Test | Used to assess walking endurance and aerobic capacity. The total distance the patient walks over six minutes is recorded. | (Day 20-22) - (Day 1-3) | 
| 6 Minute Walk Test | Used to assess walking endurance and aerobic capacity. The total distance the patient walks over six minutes is recorded. | (Day 62 to Day 86)-(Day 14 to Day 21) | 
| Stroke Impact Scale (SIS) | 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. | (Day 62 to Day 86)-(Day 14 to Day 21) | 
| Life Space Assessment (LSA) | The LSA is a self report tool that measures frequency of independent mobility using 9 questions. | (Day 62 to Day 86)-(Day 14 to Day 21) | 
| Cost of inpatient rehabilitation and post-discharge health care services | This will include the cost of home health care, outpatient therapies, subacute nursing facility and hospital readmissions | (Day 62 to Day 86) - (Day 1 to Day 3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BERG Balance Scale | A 14 item scale used to assess sitting, standing, static and dynamic balance. | (Day 13-15) - (Day 1-3) | 
| BERG Balance Scale | A 14 item scale used to assess sitting, standing, static and dynamic balance. | (Day 20-22) - (Day 1-3) | 
| BERG Balance Scale | A 14 item scale used to assess sitting, standing, static and dynamic balance. | (Day 62 to Day 86)-(Day 14 to Day 21) | 
| 5 Times Sit to Stand | Measures functional lower extremity strength and movement patterns used to complete functional movements | (Day 13-15) - (Day 1-3) | 
| 5 Times Sit to Stand | Measures functional lower extremity strength and movement patterns used to complete functional movements | (Day 20-22) - (Day 1-3) | 
| 5 Times Sit to Stand | Measures functional lower extremity strength and movement patterns used to complete functional movements | (Day 62 to Day 86)-(Day 14 to Day 21) | 
| Functional Ambulation Category (FAC) | A five point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking. | (Day 13-15) - (Day 1-3) | 
| Functional Ambulation Category (FAC) | A five point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking. | (Day 20-22) - (Day 1-3) | 
| Functional Ambulation Category (FAC) | A five point scale used to categorize a patient's ambulation status, ranging from independent walking outside to non-functional walking. | (Day 62 to Day 86)-(Day 14 to Day 21) | 
| Assistive Device Use | Document which (if any) assistive device the patient uses for ambulation. | (Day 13-15) - (Day 1-3) | 
| Assistive Device Use | Document which (if any) assistive device the patient uses for ambulation. | (Day 20-22) - (Day 1-3) | 
| Assistive Device Use | Document which (if any) assistive device the patient uses for ambulation. | (Day 62 to Day 86)-(Day 14 to Day 21) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Intensity Gait Training, Inpatient Rehabilitation, Health Care Burden