StrokeNCT04540978
Motor Activity and Its Barriers at the Early Phase Post-stroke in Acute Care Setting.
An observational study of Stroke, run by University of Haifa at 1 site in Israel.
Trial summary
Being active early after stroke prevents secondary complications, reduces hospital length of stay and improves long-term functional outcomes. Early mobilization and early rehabilitation are the means to achieve activity at the early phase post-stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2017to 30 Sep 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after ischemic stroke who are admitted to Neurological department, and who are having mild-moderate stroke-related symptoms.
Who may be able to join
- Ischemic stroke
- Admitted to the hospital within 48 hours of symptom onset
- Passed routine initial neurologic and nursing examinations within 48 hours of admission
- Score of 5-18 on the National Institutes of Health Stroke Scale (NIHSS).
Who cannot join
- Hemorrhagic stroke
- Heart failure
- Unstable hemodynamics
- Fractures
- Terminally ill
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motor Activity and Its Barriers at the Early Phase Post-stroke.
Being active early after stroke prevents secondary complications, reduces hospital length of stay and improves long-term functional outcomes. Early mobilization and early rehabilitation are the means to achieve activity at the early phase post-stroke. Performance of out-of-bed activity at an acute care setting is partially dependent on the routines used in the acute care setting, however, knowledge the knowledge about associations between clinical routines and the characteristics of out-of-bed activity is limited. Also, there is limited knowledge about institutional barriers to such activity.
Accordingly, the goal of the current study is, in acute hospital inpatient setting, to: 1) characterize stroke patients' activity according to shifts (i.e. morning and evening), 2) test associations between out-of-bed activity and patients' clinical status and 3) identify barriers to activity.
Read more
The study is a prospective observational study that monitors physical activity in people after stroke while they in an acute stroke care setting, and records berries for out-of-bed activity including being in sitting or standing and walking.
Patients are included if they admitted to the hospital within 48 hours of symptom onset, passed routine initial neurologic and nursing examinations within 48 hours of admission, and have score of 5-18 on the National Institutes of Health Stroke Scale (NIHSS). Patients are excluded if they had hemorrhagic stroke, and if they have heart failure, acute coronary syndrome, unstable hemodynamics and fractures, or if they are terminally ill.
Read the detailed description
Not required
- Conditions
- Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in sitting according to shift (i.e. morning or evening).
Body position is measured by activity monitor located at the lumbar spine.
Measured: Two weeks from admission or or until discharge.
Number of steps according to shift (i.e. morning or evening).
Number of steps is recorded by activity monitor located at the lumbar spine.
Measured: Two weeks from admission or or until discharge.
Barriers for getting out of bed.
Barriers are documented daily in a follow-up table.
Measured: Two weeks from admission or or until discharge.
Secondary outcomes (2)
Longest sitting time according to shift (i.e. morning or evening).
Body position is measured by activity monitor located at the lumbar spine.
Measured: Two weeks from admission or or until discharge.
Longest walking time according to shift (i.e. morning or evening).
Walking time is recorded by activity monitor located at the lumbar spine.
Measured: Two weeks from admission or or until discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Mar 2017
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Haifa
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv Medical Center
- Responsible party
- Principal investigator, Michal Kafri, PhD, University of Haifa
- Investigators
- Michal Kafri, PhD, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540978
- Sponsor's protocol ID
- 0787-16-TLV
- Status last verified
- Sep 2020
- First submitted
- 1 Sep 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Activity and Its Barriers at the Early Phase Post-stroke.
- ClinicalTrials.gov ID
- NCT04540978
- Acronym / sponsor ID
- 0787-16-TLV
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of HaifaUniversity, hospital or other
- Collaborators
- Tel Aviv Medical Center
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 7 Sep 2020 (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.
Being active early after stroke prevents secondary complications, reduces hospital length of stay and improves long-term functional outcomes. Early mobilization and early rehabilitation are the means to achieve activity at the early phase post-stroke. Performance of out-of-bed activity at an acute care setting is partially dependent on the routines used in the acute care setting, however, knowledge the knowledge about associations between clinical routines and the characteristics of out-of-bed activity is limited. Also, there is limited knowledge about institutional barriers to such activity.
Accordingly, the goal of the current study is, in acute hospital inpatient setting, to: 1) characterize stroke patients' activity according to shifts (i.e. morning and evening), 2) test associations between out-of-bed activity and patients' clinical status and 3) identify barriers to activity.
The study is a prospective observational study that monitors physical activity in people after stroke while they in an acute stroke care setting, and records berries for out-of-bed activity including being in sitting or standing and walking.
Patients are included if they admitted to the hospital within 48 hours of symptom onset, passed routine initial neurologic and nursing examinations within 48 hours of admission, and have score of 5-18 on the National Institutes of Health Stroke Scale (NIHSS). Patients are excluded if they had hemorrhagic stroke, and if they have heart failure, acute coronary syndrome, unstable hemodynamics and fractures, or if they are terminally ill.
Detailed description
Not required
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after ischemic stroke who are admitted to Neurological department, and who are having mild-moderate stroke-related symptoms.
Key inclusion criteria (4 listed)
- Ischemic stroke
- Admitted to the hospital within 48 hours of symptom onset
- Passed routine initial neurologic and nursing examinations within 48 hours of admission
- Score of 5-18 on the National Institutes of Health Stroke Scale (NIHSS).
Key exclusion criteria (5 listed)
- Hemorrhagic stroke
- Heart failure
- Unstable hemodynamics
- Fractures
- Terminally ill
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time in sitting according to shift (i.e. morning or evening).
Time frame: Two weeks from admission or or until discharge.
Body position is measured by activity monitor located at the lumbar spine.
Number of steps according to shift (i.e. morning or evening).
Time frame: Two weeks from admission or or until discharge.
Number of steps is recorded by activity monitor located at the lumbar spine.
Barriers for getting out of bed.
Time frame: Two weeks from admission or or until discharge.
Barriers are documented daily in a follow-up table.
2 secondary outcomes
Longest sitting time according to shift (i.e. morning or evening).
Time frame: Two weeks from admission or or until discharge.
Longest walking time according to shift (i.e. morning or evening).
Time frame: Two weeks from admission or or until discharge.
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 9 Sep 2020.
- Individual participant dataSharing planned: No
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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.
Michal Kafri, PhD principal investigator
University of Haifa
1 site 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 University of Haifa at 1 site in Israel.
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 5 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 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Time in sitting according to shift (i.e. morning or evening). (time frame: Two weeks from admission or or until discharge.). The study lists 3 primary outcomes in all. 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 9 Sep 2020.