Impact of More Frequent PT Services

November 27, 2023 updated by: Christine Holmstedt, Medical University of South Carolina

Impact of Intense Physical Therapy on Functional Mobility Outcomes in the Acute Stroke Population (<24 Hours Post-stroke)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Length of Stay
Time Frame: From hospital admission to hospital discharge
Average hospitalization (measured in days)
From hospital admission to hospital discharge
Change in Score of Postural Assessment Stroke Scale (PASS)
Time Frame: From date of hospital admission up until 90 day post hospital discharge 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.
From date of hospital admission up until 90 day post hospital discharge follow up
Change in Modified Rankin Scale
Time Frame: From date of hospital admission up until 90 days post hospital discharge 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 days follow up post discharge, 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.
From date of hospital admission up until 90 days post hospital discharge follow up
Change in Activity Measure for Post-Acute Care (AMPAC) Score
Time Frame: From date of hospital admission up until 90 day post hospital discharge 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.
From date of hospital admission up until 90 day post hospital discharge follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 24 hours of hospital admission to stroke service
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.
Within 24 hours of hospital admission
Change in National Institutes of Health Stroke Scale (NIHSS) Score
Time Frame: From date of hospital admission up until 90 day post hospital discharge 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.
From date of hospital admission up until 90 day post hospital discharge follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

National Institutes of Health (NIH)
National Institute of General Medical Sciences (NIGMS)

Investigators

  • Principal Investigator: Christine Holmstedt, DO, Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Actual)

October 14, 2022

Study Completion (Actual)

October 14, 2022

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00108635
  • 5P20GM109040 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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