Clinical trial NCT04778475: Impact of More Frequent PT Services
Official title: Impact of Intense Physical Therapy on Functional Mobility Outcomes in the Acute Stroke Population (<24 Hours Post-stroke)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mobility Limitation
Physical Disability
Stroke, Acute
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2021-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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)

Primary outcomes:
measure: Change in Score of Postural Assessment Stroke Scale (PASS)
timeFrame: From date of hospital admission up until 90 day post hospital discharge follow up
measure: Change in Modified Rankin Scale
timeFrame: From date of hospital admission up until 90 days post hospital discharge follow up
measure: Change in Activity Measure for Post-Acute Care (AMPAC) Score
timeFrame: From date of hospital admission up until 90 day post hospital discharge follow up
measure: Mean Length of Stay
timeFrame: From hospital admission to hospital discharge
Secondary outcomes:
measure: Change in National Institutes of Health Stroke Scale (NIHSS) Score
timeFrame: From date of hospital admission up until 90 day post hospital discharge follow up
measure: Mean National Institute of Health Stroke Scale Score (NIHSS)
timeFrame: within 24 hours of hospital admission to stroke service
measure: Mean Modified Rankin Scale Score
timeFrame: Within 24 hours of hospital admission
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Christine Holmstedt, DO
role: PRINCIPAL_INVESTIGATOR
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