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OpenTrials
Completed

NCT Number: NCT04540978

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tel Aviv Souraski Medical Center, Neurology Department

Tel Aviv, Israel

About this study

Not required

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Longest sitting time 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.

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

    Time frame: Two weeks from admission or or until discharge.

    Walking time is recorded by activity monitor located at the lumbar spine.

Sponsors and collaborators

Lead sponsor

University of Haifa

Other

Collaborators

  • Tel Aviv Medical Center

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 7, 2020
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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