Impact of More Frequent PT Services
Condition: Mobility Limitation; Physical Disability; Stroke, Acute
MeSH terms: Stroke; Mobility Limitation
Study type: Interventional

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.
    

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
    

Intervention name(s): Intensive therapy; Standard of care therapy
Intervention type(s): Other; Other
Intervention description(s): PT services twice a day for 3-5 days and then daily for the remainder of hospital stay; PT services 3-5 times a week for 15 to 30 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment