Motor Activity and Its Barriers at the Early Phase Post-stroke in Acute Care Setting.

Stroke Clinical Trial

Official title:

Motor Activity and Its Barriers at the Early Phase Post-stroke.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04540978
• Other study ID #: 0787-16-TLV
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: September 2020
• Source: University of Haifa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Description:

Not required

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Israel	Tel Aviv Souraski Medical Center, Neurology Department	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
University of Haifa	Tel Aviv Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in sitting according to shift (i.e. morning or evening).	Body position is measured by activity monitor located at the lumbar spine.	Two weeks from admission or or until discharge.
Primary	Number of steps according to shift (i.e. morning or evening).	Number of steps is recorded by activity monitor located at the lumbar spine.	Two weeks from admission or or until discharge.
Primary	Barriers for getting out of bed.	Barriers are documented daily in a follow-up table.	Two weeks from admission or or until discharge.
Secondary	Longest sitting time according to shift (i.e. morning or evening).	Body position is measured by activity monitor located at the lumbar spine.	Two weeks from admission or or until discharge.
Secondary	Longest walking time according to shift (i.e. morning or evening).	Walking time is recorded by activity monitor located at the lumbar spine.	Two weeks from admission or or until discharge.