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

NCT04540978 | Completed

• 1 other identifier: 0787-16-TLV
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• Barriers for getting out of bed.

  Barriers are documented daily in a follow-up table.

  Two weeks from admission or or until discharge.

Secondary Outcomes (2)

• Longest sitting time according to shift (i.e. morning or evening).

  Two weeks from admission or or until discharge.

• Longest walking time according to shift (i.e. morning or evening).

  Two weeks from admission or or until discharge.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Haifa: lead
• Tel Aviv Medical Center: collaborator

Study Sites (1)

Tel Aviv Souraski Medical Center, Neurology Department

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Michal Kafri, PhD

  University of Haifa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 7, 2020
• Study Start: March 1, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2017
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)