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

NCT ID: NCT05381220

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-14
• Study Completion Date: 2023-04-10

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 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.

Conditions

Stroke, Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

early mobilization in stroke patients

Participants in the intervention group commenced early mobilization (EM) within 24-48 hours after stroke onset. The structured program included progressive bed mobility, sitting, standing, and ambulation activities, with intensity and duration adjusted according to each patient's tolerance and neurological stability. Each session lasted approximately 30 minutes, performed once or twice daily, five days per week, and continued until hospital discharge. All sessions were conducted under the supervision of trained rehabilitation nurses and physiotherapists, with progression allowed only when vital signs were stable and no neurological deterioration was observed.

Group Type: EXPERIMENTAL

early mobilization

Intervention Type: OTHER

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

usual care in stroke patients

Participants will receive routine rehabilitation once daily, consisting of 20 minutes of bed exercises, including both active and passive joint movements.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

early mobilization

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsiao Lan Wang, University

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

National Taiwan University Hospital

Taipei County, , Taiwan

Countries

Taiwan

Other Identifiers

202202035RINC

Identifier Type: -

Identifier Source: org_study_id