NCT03257111

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

July 12, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 22, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2020

Completed
Last Updated

July 23, 2020

Status Verified

February 1, 2018

Enrollment Period

3 years

First QC Date

April 24, 2017

Last Update Submit

July 21, 2020

Conditions

Keywords

rehabilitation outcomesactivity level

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • therapy units billed

    from the date of recruitment to the date of discharge or up to 45 days whichever comes first

  • Functional Independence Measure (FIM)

    from the date of recruitment to the date of discharge or up to 45 days whichever comes first

Interventions

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 Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Florida Gulf Coast University

Fort Myers, Florida, 33965, United States

Location

Brookdale Center for Healthy Aging & Rehabilitation

Naples, Florida, 34110, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Mollie Venglar, DSc

    Florida Gulf Coast University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Compliance Coordinator

Study Record Dates

First Submitted

April 24, 2017

First Posted

August 22, 2017

Study Start

July 12, 2017

Primary Completion

July 21, 2020

Study Completion

July 21, 2020

Last Updated

July 23, 2020

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

IPD will not be shared outside of the research team

Locations