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Impact of More Frequent PT Services

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ClinicalTrials.gov Identifier: NCT04778475
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Christine Holmstedt, Medical University of South Carolina

Brief Summary:
The purpose of this study is to determine what amount of physical therapy is beneficial in the hospital setting after suffering a stroke. This study involves research. The investigators propose to enroll 150 individuals with acute stroke admitted to MUSC over the next 12 months and randomize them into increased frequency and usual care PT treatment groups. This study will be designed as a randomized control trial. If a patient agrees to participate, they will be assigned (at random) to either a treatment group which will receive more frequent therapy services or to the control group which will receive the "standard" amount of therapy services currently provided in the hospital setting (~3-5 times per week). By studying the balance, walking and success of patients in the treatment group compared with the control group- the researchers hope to better understand the effect of more frequent physical therapy services on your independence post stroke.

Condition or disease Intervention/treatment Phase
Mobility Limitation Physical Disability Stroke, Acute Other: Intensive therapy Other: Standard of care therapy Not Applicable

Detailed Description:

Early mobilization is a widely accepted pillar of acute hospital therapy services. In most populations, early mobility is regarded as safe, feasible, and yields positive results. A considerable amount of clinical and scientific literature has evaluated and upheld the positive effect of early mobility on patient safety, ICU delirium, duration of mechanical ventilation, hospital length of stay, functional mobility, ambulation ability, and mortality. However, most of the research in the field of early mobilization has focused on intensive care patients with multiple medical comorbidities.

The consideration of an acute stroke diagnosis in relation to the approach of acute care PT and "early mobility" is limited. The AVERT trial was novel in opening the doors to considering physical therapy's approach to acute stroke care on these dedicated stroke units, critical since earlier research surmised that complications of immobility could be estimated to account for as many as 51% of death in the first 30 days post stroke. The results of the AVERT trial, however, raised concern that very early mobilization may cause changes in cerebral blood flow and blood pressure leading to worsened stroke outcomes, increased mortality and increased rate of falls during early mobility.

From the publication of the AVERT trial, there has been a rise in clinical interest regarding the correlation of early mobility and improved functional outcomes post stroke. The majority of physical therapy studies in the acute stroke population have only examined the optimal time to begin mobilization post admission to the hospital. This project proposes the idea that patients with acute stroke may not be able to tolerate an extensive early mobility program. Instead, patients may benefit from shorter more frequent bouts of therapy early in their recovery to focus on specific areas such as seated postural control, motor recruitment strategies, and transfer training delivered in separate sessions. The investigators hypothesize that the approach of shorter, more frequent bouts of quality therapy services will negate the post stroke fatigue factor. Thus, allowing patients to progress functional mobility with improved tolerance to therapy sessions, frequent repetition, as well as implementation of motor learning principles to ensure carryover by providing distributed over massed practice. The research in the field of neuroplasticity and neuro rehabilitation illustrates the importance of high intensity, repetitive and aggressive approaches for motor recovery, however, most of this research has been performed in the subacute stroke population.

Rather than decreasing the time to upright mobility, it may be beneficial to examine the effect of short bouts of more frequent mobilization in these patients, within the early stages of their hospitalization. If, as assumed, a prolonged duration of upright sitting posture has a negative effect on cerebral blood flow10 it may be possible to gain the positive effects of early mobility by continuing to provide PT services while combating the negative effects of cerebral perfusion by returning all patients to a supine position in bed following therapy services within the first 24 hours of acute stroke. This study aims to examine the approach of increased frequency of physical therapy services as a way to gain the benefits of the publicized early mobility approach, while weighing the concerns raised by previous trials and decreasing amount of time left upright to combat negative effects of cerebral perfusion on the ischemic penumbra. As part of this study, there will be an experimental group of participants who will receive PT sessions twice a day for the first three out of five days of admission, followed by daily treatment sessions at an intensity of at least 20-50-minute bouts. This group will be compared to a group of control participants who will receive standard PT services 3-5x/wk (on average 8-23 minutes/session) while in the acute hospital setting. Outcomes of interest include average length of stay, discharge disposition, Postural Assessment Stroke Scale & Modified Rankin Scale scores, and rate of readmission at 30 days. There is a critical need to evaluate how the mobilization approach of patients with acute stroke during their hospitalization impacts their discharge disposition, length of stay, and future functional outcomes

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Intense Physical Therapy on Functional Mobility Outcomes in the Acute Stroke Population (<24 Hours Post-stroke)
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : March 30, 2022

Arm Intervention/treatment
Experimental: Group A
The treatment group will receive increased frequency of PT services within the first 3-5 days of admission, followed by daily PT services for the duration of their inpatient stay.
Other: Intensive therapy
PT services twice a day for 3-5 days and then daily for the remainder of hospital stay

Active Comparator: Group B
The control group will receive standard care of PT services 3-5 times per week during their hospitalization.
Other: Standard of care therapy
PT services 3-5 times a week for 15 to 30 minutes




Primary Outcome Measures :
  1. Change in Score of Postural Assessment Stroke Scale (PASS) during hospital admission [ Time Frame: Within 24 hours of hospital admission and within 24 hours of prior to discharge from hospital system ]
    The scale measures 12 items of balance in sitting, lying and standing with increasing amounts of difficulty. It consists of a 4 point scale, measured from 0 to 3 with scores that range from 0-36. Patients with a lower score have a more severe impairment, and patients with a higher score have a less severe impairment.

  2. Change in Score of Postural Assessment Stroke Scale (PASS) at follow up [ Time Frame: Within 24 hours of hospital discharge and at 90 day stroke clinic follow up ]
    The scale measures 12 items of balance in sitting, lying and standing with increasing amounts of difficulty. It consists of a 4 point scale, measured from 0 to 3 with scores that range from 0-36. Patients with a lower score have a more severe impairment, and patients with a higher score have a less severe impairment.

  3. Overall change in Score of Postural Assessment Stroke Scale (PASS) [ Time Frame: Within 24 hours of hospital admission and at 90 day stroke clinic follow up ]
    The scale measures 12 items of balance in sitting, lying and standing with increasing amounts of difficulty. It consists of a 4 point scale, measured from 0 to 3 with scores that range from 0-36. Patients with a lower score have a more severe impairment, and patients with a higher score have a less severe impairment.

  4. Change in score on National Institutes of Health Stroke Scale (NIHSS) Score [ Time Frame: Within 24 hours of hospital admission and at 90 day stroke clinic follow up ]
    The scale measures the severity of symptoms associated with patient's stroke. It assesses the severity of impairments related to stroke. The impairments are graded on a 3-4 point scale with scores that range from 0-42. Patients with a higher score have a more severe impairment, and patients with a lower score have a less severe impairment.

  5. Overall Change Activity Measure for Post-Acute Care (AMPAC) Score [ Time Frame: Within 24 hours of hospital admission and at 90 day stroke clinic follow up ]
    The scale measures basic mobility in the hospital setting including moving around in bed, getting out of bed, sitting and standing, moving from a bed to a chair, walking, and going up and down stairs. It consists of a 4 point scale measured from 1 to 4 with scores that range from 6 to 24. Patients with a lower score have a more severe impairment, and patients with a higher score have a less severe impairment.

  6. Change in Modified Rankin Scale [ Time Frame: With 24 hours of discharge from hospital system to 90 day stroke clinic follow up ]
    The scale is a questionnaire that asks patients about their ability to perform activities of daily living (ADL's) taking into account their physical, mental, and speech performance. On admission the questionnaire focuses on their ability to perform ADL's prior to their stroke. At discharge and at 90 day follow up the questionnaire focuses on their ability to perform ADL's at that time point. It is scored from 0 to 5. Patients with a lower score have a less severe impairment, and patients with a higher score have a more severe impairment.


Secondary Outcome Measures :
  1. Change in Activity Measure for Post-Acute Care (AMPAC) Score while inpatient [ Time Frame: Within 24 hours of hospital admission and within 24 hours of prior to discharge from hospital system ]
    The scale measures basic mobility in the hospital setting including moving around in bed, getting out of bed, sitting and standing, moving from a bed to a chair, walking, and going up and down stairs. It consists of a 4 point scale measured from 1 to 4 with scores that range from 6 to 24. Patients with a lower score have a more severe impairment, and patients with a higher score have a less severe impairment.

  2. Change in Activity Measure for Post-Acute Care (AMPAC) Score from discharge to follow up [ Time Frame: Within 24 hours of hospital discharge and at 90 day stroke clinic follow up ]
    The scale measures basic mobility in the hospital setting including moving around in bed, getting out of bed, sitting and standing, moving from a bed to a chair, walking, and going up and down stairs. It consists of a 4 point scale measured from 1 to 4 with scores that range from 6 to 24. Patients with a lower score have a more severe impairment, and patients with a higher score have a less severe impairment.

  3. Change in National Institutes of Health Stroke Scale (NIHSS) Score [ Time Frame: Within 24 hours of hospital admission and within 24 hours of discharge from hospital system ]
    The scale measures the severity of symptoms associated with patient's stroke. It assesses the severity of impairments related to stroke. The impairments are graded on a 3-4 point scale with scores that range from 0-42. Patients with a higher score have a more severe impairment, and patients with a lower score have a less severe impairment.

  4. Change in National Institutes of Health Stroke Scale (NIHSS) Score [ Time Frame: Within 24 hours of hospital discharge and at 90 day stroke clinic follow up ]
    The scale measures the severity of symptoms associated with patient's stroke. It assesses the severity of impairments related to stroke. The impairments are graded on a 3-4 point scale with scores that range from 0-42. Patients with a higher score have a more severe impairment, and patients with a lower score have a less severe impairment.

  5. Mean National Institute of Health Stroke Scale Score (NIHSS) [ Time Frame: within 24 hours of hospital admission to stroke service ]
    The scale measures the severity of symptoms associated with patient's stroke. It assesses the severity of impairments related to stroke. The impairments are graded on a 3-4 point scale with scores that range from 0-42. Patients with a higher score have a more severe impairment, and patients with a lower score have a less severe impairment.

  6. Mean Modified Rankin Scale Score [ Time Frame: Within 24 hours of hospital admission ]
    The scale is a questionnaire that asks patients about their ability to perform activities of daily living (ADL's) taking into account their physical, mental, and speech performance. On admission the questionnaire focuses on their ability to perform ADL's prior to their stroke. At discharge and at 90 day follow up the questionnaire focuses on their ability to perform ADL's at that time point. It is scored from 0 to 5. Patients with a lower score have a less severe impairment, and patients with a higher score have a more severe impairment.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute stroke
  • NIH score of 2-15 with motor involvement
  • Age </=80yo
  • Medical stability for increased therapy services( determined by Stroke Service NP)

Exclusion Criteria:

  • Inability or unwillingness of subject or legal guardian/representative to give -informed consent
  • Medical instability or cerebral perfusion dependence, requiring bed rest
  • Pregnancy (noted in chart)
  • Inmates (noted in chart)
  • COVID-19 infection (PCR positive labs)
  • Dialysis (noted in chart & performed while inpatient)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04778475


Contacts
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Contact: Christine Holmstedt, DO 8437923020 holmstedt@musc.edu

Sponsors and Collaborators
Medical University of South Carolina
National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Investigators
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Principal Investigator: Christine Holmstedt, DO Medical University of South Carolina
Publications:

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Responsible Party: Christine Holmstedt, Professor of Neurology and Emergency Medicine, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04778475    
Other Study ID Numbers: 00108635
5P20GM109040 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Mobility Limitation
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases