Clinical trial NCT04540978: Motor Activity and Its Barriers at the Early Phase Post-stroke in Acute Care Setting.
Official title: Motor Activity and Its Barriers at the Early Phase Post-stroke.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: University of Haifa
Sponsor class: OTHER
Collaborators: name: Tel Aviv Medical Center
First posted: 2020-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after ischemic stroke who are admitted to Neurological department, and who are having mild-moderate stroke-related symptoms.

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* Hemorrhagic stroke
* Heart failure
* Unstable hemodynamics
* Fractures
* Terminally ill

Primary outcomes:
measure: Time in sitting according to shift (i.e. morning or evening).
timeFrame: Two weeks from admission or or until discharge.
measure: Number of steps according to shift (i.e. morning or evening).
timeFrame: Two weeks from admission or or until discharge.
measure: Barriers for getting out of bed.
timeFrame: Two weeks from admission or or until discharge.
Secondary outcomes:
measure: Longest sitting time according to shift (i.e. morning or evening).
timeFrame: Two weeks from admission or or until discharge.
measure: Longest walking time according to shift (i.e. morning or evening).
timeFrame: Two weeks from admission or or until discharge.
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Souraski Medical Center, Neurology Department
Study officials:
affiliation: University of Haifa
name: Michal Kafri, PhD
role: PRINCIPAL_INVESTIGATOR
References: