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

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05381220
• Other study ID #: 202202035RINC
• Status: Completed
• Phase: N/A
• Start date: April 14, 2022
• Est. completion date: April 10, 2023

Study information

• Verified date: April 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 10, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Must be over 20 years old.
• Patients diagnosed with infarct or hemorrhagic stroke 24 to 72 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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei county

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess changes in functional status	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.	Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.
Primary	Assess changes in sychological distress	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.	Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.
Primary	Assess changes in quality of life	The Stroke Impact Scale (SIS) assesses other dimensions of health related quality of life: emotion, communication, memory and thinking, and social role function, The total SIS score was ranged from 16 to 90. The higher scores mean a better outcome.	Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.