Clinical trial NCT05650606: Inpatient Rehabilitation and Post-Discharge Outcomes With High Intensity Gait Training (HIGT) of Patients With Stroke
Official title: Inpatient Rehabilitation and Post-Discharge Outcomes of Patients With Stroke Participating in High Intensity Gait Training
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cerebral Vascular Accident
Keywords: High Intensity Gait Training
Inpatient Rehabilitation
Health Care Burden
Lead sponsor: Sunnyview Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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
    * 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.

Primary outcomes:
measure: 10 Meter Walk Test at Self Selected Speed
timeFrame: (Day 13-15) - (Day 1-3)
measure: 10 Meter Walk Test at Self Selected Speed
timeFrame: (Day 20-22)- (Day 1-3)
measure: 10 Meter Walk Test at Self Selected Speed
timeFrame: (Day 62 to Day 86)-(Day 14 to Day 21)
measure: 10 Meter Walk Test at Fast Speed
timeFrame: (Day 13-15) - (Day 1-3)
measure: 10 Meter Walk Test at Fast Speed
timeFrame: (Day 20-22) - (Day 1-3)
measure: 10 Meter Walk Test at Fast Speed
timeFrame: (Day 62 to Day 86)-(Day 14 to Day 21)
measure: 6 Minute Walk Test
timeFrame: (Day 13-15) - (Day 1-3)
measure: 6 Minute Walk Test
timeFrame: (Day 20-22) - (Day 1-3)
measure: 6 Minute Walk Test
timeFrame: (Day 62 to Day 86)-(Day 14 to Day 21)
measure: Stroke Impact Scale (SIS)
timeFrame: (Day 62 to Day 86)-(Day 14 to Day 21)
measure: Life Space Assessment (LSA)
timeFrame: (Day 62 to Day 86)-(Day 14 to Day 21)
measure: Cost of inpatient rehabilitation and post-discharge health care services
timeFrame: (Day 62 to Day 86) - (Day 1 to Day 3)
Secondary outcomes:
measure: BERG Balance Scale
timeFrame: (Day 13-15) - (Day 1-3)
measure: BERG Balance Scale
timeFrame: (Day 20-22) - (Day 1-3)
measure: BERG Balance Scale
timeFrame: (Day 62 to Day 86)-(Day 14 to Day 21)
measure: 5 Times Sit to Stand
timeFrame: (Day 13-15) - (Day 1-3)
measure: 5 Times Sit to Stand
timeFrame: (Day 20-22) - (Day 1-3)
measure: 5 Times Sit to Stand
timeFrame: (Day 62 to Day 86)-(Day 14 to Day 21)
measure: Functional Ambulation Category (FAC)
timeFrame: (Day 13-15) - (Day 1-3)
measure: Functional Ambulation Category (FAC)
timeFrame: (Day 20-22) - (Day 1-3)
measure: Functional Ambulation Category (FAC)
timeFrame: (Day 62 to Day 86)-(Day 14 to Day 21)
measure: Assistive Device Use
timeFrame: (Day 13-15) - (Day 1-3)
measure: Assistive Device Use
timeFrame: (Day 20-22) - (Day 1-3)
measure: Assistive Device Use
timeFrame: (Day 62 to Day 86)-(Day 14 to Day 21)
Other outcomes:
Locations:
city: Schenectady
country: United States
facility: Sunnyview Rehabilitation Hospital
state: New York
Study officials:
affiliation: Sunnyview Rehabilitation Hospital
name: Patricia Broschart Valenza, DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernhardt J, Hayward KS, Kwakkel G, Ward NS, Wolf SL, Borschmann K, Krakauer JW, Boyd LA, Carmichael ST, Corbett D, Cramer SC. Agreed Definitions and a Shared Vision for New Standards in Stroke Recovery Research: The Stroke Recovery and Rehabilitation Roundtable Taskforce. Neurorehabil Neural Repair. 2017 Sep;31(9):793-799. doi: 10.1177/1545968317732668.
citation: Biernaskie J, Chernenko G, Corbett D. Efficacy of rehabilitative experience declines with time after focal ischemic brain injury. J Neurosci. 2004 Feb 4;24(5):1245-54. doi: 10.1523/JNEUROSCI.3834-03.2004.
citation: Dromerick AW, Geed S, Barth J, Brady K, Giannetti ML, Mitchell A, Edwardson MA, Tan MT, Zhou Y, Newport EL, Edwards DF. Critical Period After Stroke Study (CPASS): A phase II clinical trial testing an optimal time for motor recovery after stroke in humans. Proc Natl Acad Sci U S A. 2021 Sep 28;118(39):e2026676118. doi: 10.1073/pnas.2026676118.
citation: Hornby TG, Holleran CL, Leddy AL, Hennessy P, Leech KA, Connolly M, Moore JL, Straube D, Lovell L, Roth E. Feasibility of Focused Stepping Practice During Inpatient Rehabilitation Poststroke and Potential Contributions to Mobility Outcomes. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):923-32. doi: 10.1177/1545968315572390. Epub 2015 Feb 26.
citation: Hornby TG, Holleran CL, Hennessy PW, Leddy AL, Connolly M, Camardo J, Woodward J, Mahtani G, Lovell L, Roth EJ. Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2016 Jun;30(5):440-50. doi: 10.1177/1545968315604396. Epub 2015 Sep 3.
citation: Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.
citation: Hornby TG, Reisman DS, Ward IG, Scheets PL, Miller A, Haddad D, Fox EJ, Fritz NE, Hawkins K, Henderson CE, Hendron KL, Holleran CL, Lynskey JE, Walter A; and the Locomotor CPG Appraisal Team. Clinical Practice Guideline to Improve Locomotor Function Following Chronic Stroke, Incomplete Spinal Cord Injury, and Brain Injury. J Neurol Phys Ther. 2020 Jan;44(1):49-100. doi: 10.1097/NPT.0000000000000303.
citation: Jordan N, Deutsch A. (2021). Why and How to Demonstrate the Value of Rehabilitation Services. ACRM, 000:1-6. https://doi.org/10.1016/j.apmr.2021.06.028
citation: Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
citation: Moore JL, Nordvik JE, Erichsen A, Rosseland I, Bo E, Hornby TG; FIRST-Oslo Team. Implementation of High-Intensity Stepping Training During Inpatient Stroke Rehabilitation Improves Functional Outcomes. Stroke. 2020 Feb;51(2):563-570. doi: 10.1161/STROKEAHA.119.027450. Epub 2019 Dec 30.