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Clinical Trials/NCT05650606
NCT05650606
Terminated
Not Applicable

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

Sunnyview Rehabilitation Hospital1 site in 1 country2 target enrollmentMarch 18, 2023

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.

Registry
clinicaltrials.gov
Start Date
March 18, 2023
End Date
October 11, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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))

Study Sites (1)

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