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Activity Levels and Rehabilitation Outcomes of Patients Post-stroke

This study is not yet open for participant recruitment.
Verified August 2017 by Mollie Venglar DSc, MSPT, NCS, Florida Gulf Coast University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03257111
First Posted: August 22, 2017
Last Update Posted: August 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Brookdale Center for Healthy Aging & Rehabilitation
Information provided by (Responsible Party):
Mollie Venglar DSc, MSPT, NCS, Florida Gulf Coast University
  Purpose
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.

Condition Intervention
Stroke Other: activity monitors

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Correlation Between Activity Levels and Rehabilitation Outcomes of Patients Post-stroke in an In-patient Rehabilitation Center

Resource links provided by NLM:


Further study details as provided by Mollie Venglar DSc, MSPT, NCS, Florida Gulf Coast University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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

  • 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


Estimated Enrollment: 120
Anticipated Study Start Date: August 2017
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: activity monitors
    activity monitors are worn on the wrist, much like a watch. Data from the activity monitors will be downloaded once a week and at discharge. Normal hospital and therapy activities will not be altered.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
  Contacts and Locations
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): NCT03257111


Contacts
Contact: Mollie Venglar, DSc 239-590-7559 mvenglar@fgcu.edu
Contact: Renee Jeffreys-Heil, PhD 239-590-1169 rjeffreysheil@fgcu.edu

Locations
United States, Florida
Florida Gulf Coast University Not yet recruiting
Fort Myers, Florida, United States, 33965
Contact: Mollie Venglar, DSc    239-590-7559    mvenglar@fgcu.edu   
Brookdale Center for Healthy Aging & Rehabilitation Not yet recruiting
Naples, Florida, United States, 34110
Contact: Mollie Venglar, DSc    239-590-7559    mvenglar@fgcu.edu   
Sponsors and Collaborators
Florida Gulf Coast University
Brookdale Center for Healthy Aging & Rehabilitation
Investigators
Principal Investigator: Mollie Venglar, DSc Florida Gulf Coast University
  More Information

Responsible Party: Mollie Venglar DSc, MSPT, NCS, Assistant Professor, Florida Gulf Coast University
ClinicalTrials.gov Identifier: NCT03257111     History of Changes
Other Study ID Numbers: 2016-104
First Submitted: April 24, 2017
First Posted: August 22, 2017
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared outside of the research team

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mollie Venglar DSc, MSPT, NCS, Florida Gulf Coast University:
rehabilitation outcomes
activity level

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases