Back to resultsThe Effect of Early Mobilization in Stroke Patients on Functional Status, Psychological Distress, and Quality of Life
Primary Purpose
Stroke, Acute
Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
early mobilization
Sponsored by
About this trial
This is an interventional supportive care trial for Stroke, Acute focused on measuring stroke, early mobilization
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
Sites / Locations
- National Taiwan University Hospital
- National Taiwan University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
early mobilization in stroke patients
usual care in stroke patients
Arm Description
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.
usual care
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05381220
First Posted
April 24, 2022
Last Updated
January 16, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05381220
Brief Title
The Effect of Early Mobilization in Stroke Patients on Functional Status, Psychological Distress, and Quality of Life
Official Title
The Effect of Early Mobilization in Stroke Patients on Functional Status, Psychological Distress, and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 14, 2022 (Actual)
Primary Completion Date
May 16, 2022 (Actual)
Study Completion Date
April 11, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
stroke, early mobilization
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
102 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
early mobilization in stroke patients
Arm Type
Experimental
Arm Description
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.
Arm Title
usual care in stroke patients
Arm Type
No Intervention
Arm Description
usual care
Intervention Type
Other
Intervention Name(s)
early mobilization
Intervention Description
Received early activities provided by the Institute 24 hours after stroke
Primary Outcome Measure Information:
Title
Assess changes in functional status
Description
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.
Time Frame
Change from Baseline psychological distress at 1and 3 months.
Title
Assess changes in sychological distress
Description
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.
Time Frame
Change from Baseline functional status at 2 weeks, 1, and 3 months.
Title
Assess changes in quality of life
Description
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.
Time Frame
Change from Baseline quality of life at 1and 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsiao Lan Wang, University
Organizational Affiliation
National Taiwan University Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei county
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Early Mobilization in Stroke Patients on Functional Status, Psychological Distress, and Quality of Life
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