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

NCT05381220 | Completed

• 1 other identifier: 202202035RINC
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke, Acute

Keywords

stroke; early mobilization

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Secondary Outcomes (1)

• Assess changes in quality of life

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

Study Arms (2)

early mobilization in stroke patients

EXPERIMENTAL

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.

Other: early mobilization

usual care in stroke patients

NO INTERVENTION

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

Interventions

early mobilization OTHER

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

early mobilization in stroke patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

National Taiwan University Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei County, Taiwan

Location

MeSH Terms

Conditions

Stroke

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Hsiao Lan Wang, University

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: May 19, 2022
• Study Start: April 14, 2022
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: November 19, 2025

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)