Activity Levels and Rehabilitation Outcomes of Patients Post-stroke

July 21, 2020 updated by: Sherry Alexander, Florida Gulf Coast University

The Correlation Between Activity Levels and Rehabilitation Outcomes of Patients Post-stroke in an In-patient Rehabilitation Center

Patients admitted to the in-patient rehabilitation center with a diagnosis of stroke will be recruited into the study. The participants will wear two activity monitors (one commercial grade and one research grade) for the duration of their rehab stay. Data from the monitors will be correlated with rehab outcomes, therapy units billed, and length of stay.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

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
    • Florida
      • Fort Myers, Florida, United States, 33965
        • Florida Gulf Coast University
      • Naples, Florida, United States, 34110
        • Brookdale Center for Healthy Aging & Rehabilitation

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

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will include only people with a diagnosis of stroke who have been admitted to the in-patient rehabilitation facility "Brookdale Center for Healthy Aging & Rehabilitation" in Naples, FL. The side of the stroke, the type of the stroke, or a history of prior stroke are not considerations. The study is intended to be very clinically focused to better understand the activity level of the population seen at the facility. This study is purposely not controlling the population to a very narrow presentation so that the results will speak directly to the facility and their outcomes

Description

Inclusion Criteria:

  • diagnosis of stroke
  • patient at the Brookdale Center for Healthy Aging & Rehabilitation
  • not greater than maximum assistance to walk 10 feet
  • walking re-training included in the therapy plan of care

Exclusion Criteria:

  • primary diagnosis other than stroke
  • allergy or reaction to the wrist bands of the activity monitors

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity Level
Time Frame: from the date of recruitment to the date of discharge or up to 45 days whichever comes first
Amount of physical activity each day and throughout rehab stay as measured by 2 activity monitors beginning at admission and ending at discharge from the facility
from the date of recruitment to the date of discharge or up to 45 days whichever comes first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
therapy units billed
Time Frame: from the date of recruitment to the date of discharge or up to 45 days whichever comes first
therapy units are billed 15 minute time blocks; the number of each type of unit will be assessed at discharge from the facility
from the date of recruitment to the date of discharge or up to 45 days whichever comes first
Functional Independence Measure (FIM)
Time Frame: from the date of recruitment to the date of discharge or up to 45 days whichever comes first
FIM is a standard rehabilitation outcome used in all rehabilitation hospitals; measured at admission and discharge from the facility
from the date of recruitment to the date of discharge or up to 45 days whichever comes first

Collaborators and Investigators

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

Sponsor

Florida Gulf Coast University

Collaborators

Brookdale Center for Healthy Aging & Rehabilitation

Investigators

  • Principal Investigator: Mollie Venglar, DSc, Florida Gulf Coast University

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)

July 12, 2017

Primary Completion (Actual)

July 21, 2020

Study Completion (Actual)

July 21, 2020

Study Registration Dates

First Submitted

April 24, 2017

First Submitted That Met QC Criteria

August 18, 2017

First Posted (Actual)

August 22, 2017

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared outside of the research team

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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