Activity Levels and Rehabilitation Outcomes of Patients Post-stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257111
• Other study ID #: 2016-104
• Status: Completed
• Start date: July 12, 2017
• Est. completion date: July 21, 2020

Study information

• Verified date: February 2018
• Source: Florida Gulf Coast University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 21, 2020
• Est. primary completion date: July 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Florida Gulf Coast University	Fort Myers	Florida
United States	Brookdale Center for Healthy Aging & Rehabilitation	Naples	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida Gulf Coast University	Brookdale Center for Healthy Aging & Rehabilitation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Level	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	therapy units billed	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
Secondary	Functional Independence Measure (FIM)	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