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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05381220

Collaborator

(none)

102

Enrollment

Locations

Arms

11.9

Anticipated Duration (Months)

Patients Per Site

4.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute	Other: early mobilization	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Apr 14, 2022

Anticipated Primary Completion Date :

May 16, 2022

Anticipated Study Completion Date :

Apr 11, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: early mobilization in stroke patients 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 Received early activities provided by the Institute 24 hours after stroke
No Intervention: usual care in stroke patients usual care

Arm

Intervention/Treatment

Experimental: early mobilization in stroke patients

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

Received early activities provided by the Institute 24 hours after stroke

No Intervention: usual care in stroke patients

usual care

Outcome Measures

Primary Outcome Measures

Assess changes in functional status [Change from Baseline psychological distress at 1and 3 months.]
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 [Change from Baseline functional status at 2 weeks, 1, and 3 months.]
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 [Change from Baseline quality of life at 1and 3 months.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei county		Taiwan
2	National Taiwan University Hospital	Taipei		Taiwan

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator: Hsiao Lan Wang, University, National Taiwan University Hospital, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT05381220

Other Study ID Numbers:

202202035RINC

First Posted:

May 19, 2022

Last Update Posted:

May 26, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Taiwan University Hospital

stroke

early mobilization

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of May 26, 2022