Clinical trial NCT05381220: The Effects of Early Mobilization in Stroke Patients on Functional Status, Psychological Distress, and Quality of Life
Official title: The Effects of Early Mobilization in Stroke Patients on Functional Status, Psychological Distress, and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Acute
Keywords: stroke
early mobilization
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 102
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Assess changes in functional status
timeFrame: Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.
measure: Assess changes in sychological distress
timeFrame: Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.
measure: Assess changes in quality of life
timeFrame: Data were collected at three measurement time points: baseline, the fourth week, and the 12th week after stroke.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital, Taiwan
name: Hsiao Lan Wang, University
role: PRINCIPAL_INVESTIGATOR
References: