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

Study Overview
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Brief Summary
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the purpose of this study was to investigate the effect of early activity intervention on the functional status, psychological distress and quality of life of stroke patients. It is expected that through early activities, the degree of disability of acute cerebral stroke patients can be reduced, the hemiplegic limbs can be restored, the function of activities of daily living can be improved, and anxiety and depression after stroke can be reduced, thereby greatly improving the quality of life.

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

Conditions
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Stroke, Acute

Intervention / Treatment
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* Other: early mobilization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: early mobilization in stroke patients<br>The first day is to elevate the head of the bed and sit for 5 minutes The second day is to elevate the head of the bed for 10 minutes and sit on the edge of the bed for 5 minutes. The third day, sit on the edge of the bed for 10 minutes, get out of bed and stand for 10 minutes, and standing still for 5 minutes. The activity time is about 25 minutes each time, and the activity frequency is 2 times a day for 3 days. | Other: early mobilization<br>* Received early activities provided by the Institute 24 hours after stroke<br>|
| No Intervention: usual care in stroke patients<br>usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline psychological distress at 1and 3 months. | 
| 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. | Change from Baseline functional status at 2 weeks, 1, and 3 months. | 
| 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. | Change from Baseline quality of life at 1and 3 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, early mobilization