StrokeNCT03257111
Activity Levels and Rehabilitation Outcomes of Patients Post-stroke
An observational study of Stroke, run by Florida Gulf Coast University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- activity monitors
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jul 2017to 21 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- primary diagnosis other than stroke
- allergy or reaction to the wrist bands of the activity monitors
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Florida Gulf Coast University
Fort Myers, Florida, 33965
Brookdale Center for Healthy Aging & Rehabilitation
Naples, Florida, 34110
About this study
Official title: 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.
- Conditions
- Stroke
- Being tested
- activity monitors
- Keywords
- rehabilitation outcomes, activity level
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activity monitorsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from the date of recruitment to the date of discharge or up to 45 days whichever comes first
Secondary outcomes (2)
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
Measured: from the date of recruitment to the date of discharge or up to 45 days whichever comes first
Functional Independence Measure (FIM)
FIM is a standard rehabilitation outcome used in all rehabilitation hospitals; measured at admission and discharge from the facility
Measured: from the date of recruitment to the date of discharge or up to 45 days whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start12 Jul 2017
- Primary completion21 Jul 2020
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida Gulf Coast University
- Sponsor type
- University, hospital or other
- Collaborators
- Brookdale Center for Healthy Aging & Rehabilitation
- Responsible party
- Principal investigator, Sherry Alexander, Florida Gulf Coast University
- Investigators
- Mollie Venglar, DSc, Principal investigator, Florida Gulf Coast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257111
- Sponsor's protocol ID
- 2016-104
- Status last verified
- Feb 2018
- First submitted
- 24 Apr 2017
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared outside of the research team
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Activity Levels and Rehabilitation Outcomes of Patients Post-stroke in an In-patient Rehabilitation Center
- ClinicalTrials.gov ID
- NCT03257111
- Acronym / sponsor ID
- 2016-104
- Conditions
- Stroke
- Keywords
- rehabilitation outcomes, activity level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Florida Gulf Coast UniversityUniversity, hospital or other
- Collaborators
- Brookdale Center for Healthy Aging & Rehabilitation
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 21 Jul 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- primary diagnosis other than stroke
- allergy or reaction to the wrist bands of the activity monitors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| activity monitorsactivity 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. | Other | – |
Primary outcome
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
2 secondary outcomes
therapy units billed
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Individual participant dataSharing planned: No. IPD will not be shared outside of the research team
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mollie Venglar, DSc principal investigator
Florida Gulf Coast University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Florida Gulf Coast University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Activity Level (time frame: from the date of recruitment to the date of discharge or up to 45 days whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.