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NCT Number: NCT05381220

The Effects of Early Mobilization in Stroke Patients on Functional Status, Psychological Distress, and Quality of Life

This study aims to investigate the effects of an early mobilization intervention in improving functional status, psychological distress, and quality of life in stroke patients. We hypothesize that this intervention method can significantly alleviate patient anxiety and depression, thereby promoting functional recovery and enhancing overall quality of life. Through this research, we hope to provide stroke patients with more effective exercise programs to help them regain health and well-being.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital, Taipei, Taiwan

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About this study

This study employs an experimental design conducted on patients in the stroke unit of the hospital who are over 20 years old and have either ischemic or hemorrhagic stroke with stable vital signs post-stroke onset, limb muscle strength greater than 3 points, and good communication skills in Chinese and Taiwanese, or they can read Chinese. Eligible participants are divided into an experimental group and a control group. All participants receive standard stroke unit care, while the intervention group additionally undergoes a 3-day activity protocol. The primary and secondary outcomes are assessed at baseline and at 1, 4, and 12 weeks post-stroke. Finally, the study analyzes the effect of early intervention on improving the prognosis of stroke patients.

The data collected in this study, whether in paper form or electronically, will be documented on a computer. After completing the research report, any recordings and paper documents will be destroyed. Once the data is documented, identifiable patient information will be removed, and each record will be assigned a unique code, making individual data unidentifiable.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must be over 20 years old.
  • Patients diagnosed with infarct or hemorrhagic stroke 24 to 48 hours later. -Patients with stable vital signs, systolic blood pressure between 140- 220mmHg, heartbeat 40-130bpm, blood oxygen >92%.
  • The muscle strength of the limbs is greater than 3 points.
  • Can communicate in Chinese and Taiwanese.

Exclusion criteria

  • Patients with severe mental illness, critically ill patients and cognitive dysfunction.
  • Surgery patients, aphasia patients.
  • NIHSS greater than 16 points for severe stroke

Treatment and study plan

Early mobilization

Other

Patients will receive early mobilization measures within 24 to 48 hours after the onset of stroke.

Primary outcomes

  1. Assess changes in functional status

    Time frame: Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.

    Functional status was assessed by Barthel Activity Daily Index (BI) and modified Rankin scale (mRS) were applied to assess activities of daily life with stroke patients. The BI is consisting of 10 common activities of daily living activities. Eight of the ten items represent activities related to personal care; the remaining 2 are related to mobility. A total score out of 100; the higher the score, the greater the degree of functional independence. The mRS scale runs from 0-6, the score of 0 is no disability, 5 is disability requiring constant care for all needs, and 6 is death.

  2. Assess changes in sychological distress

    Time frame: Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.

    Psychological distress was measured using the Hospital Anxiety and Depression Scale (HADS) scale. It consists of 14 items, which can be divided into two subscales of seven items each: the anxiety subscale (HADS-A) and the depression subscale (HADS-D). The total HADS score was ranged from 0 to 21. A score greater than or equal to 11 indicates that the patient has anxiety or depression.

Secondary outcomes

  1. Assess changes in quality of life

    Time frame: Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.

    Quality of life was assessed using the Stroke Impact Scale (SIS) Version 3.0, which contains 59 items covering eight domains, including strength, memory and thinking, emotion, communication, activities of daily living/instrumental activities of daily living (ADL/IADL), mobility, hand function, and participation, plus one recovery item. Each domain is scored from 0 to 100, with higher scores indicating better quality of life.

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 19, 2022
Registry last updated
Nov 19, 2025

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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