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

NCT05650606 | Terminated

• 1 other identifier: 22-0912-1
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Vascular Accident

Keywords

High Intensity Gait Training; Inpatient Rehabilitation; Health Care Burden

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (12)

• BERG Balance Scale

  (Day 13-15) - (Day 1-3)

• BERG Balance Scale

  (Day 20-22) - (Day 1-3)

• BERG Balance Scale

  (Day 62 to Day 86)-(Day 14 to Day 21)

• 5 Times Sit to Stand

  (Day 13-15) - (Day 1-3)

• 5 Times Sit to Stand

  (Day 20-22) - (Day 1-3)

Study Arms (2)

High Intensity Gait Training

EXPERIMENTAL

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

Conventional

ACTIVE COMPARATOR

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

Interventions

High Intensity Gait Training OTHER

Physical therapy intervention for improving gait in patients post Cerebral Vascular Accident.

High Intensity Gait Training

Conventional Therapy OTHER

Standard inpatient rehabilitation physical therapy treatments for Cerebral Vascular Accident.

Conventional

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnyview Rehabilitation Hospital: lead

Study Sites (1)

Sunnyview Rehabilitation Hospital

Schenectady, New York, 12308, United States

Location

Related Publications (10)

• 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.

  PMID: 28934920 BACKGROUND

• 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.

  PMID: 14762143 BACKGROUND

• 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.

  PMID: 34544853 BACKGROUND

• 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.

  PMID: 25721233 BACKGROUND

• 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.

  PMID: 26338433 BACKGROUND

• 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.

  PMID: 31434543 BACKGROUND

• 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.

  PMID: 31834165 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 35078371 BACKGROUND

• 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.

  PMID: 31884902 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Patricia Broschart Valenza, DPT

  Sunnyview Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Therapy Supervisor

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: March 18, 2023
• Primary Completion: October 11, 2023
• Study Completion: October 11, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

US (1)