Feasibility and Effectiveness of Rehabilitation Nursing for Acute Stroke
Primary Purpose
Acute Ischemic Stroke, Nursing
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The modified Barthel Index-based rehabilitation nursing program
Usual care
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Ischemic Stroke
Eligibility Criteria
Inclusion Criteria:
- diagnosed with ischemic stroke and met the diagnostic criteria of the World Health Organization;
- initial stroke within seven days, with limb dysfunction;
- NIHSS scale consciousness scores of 0 or 1;
- provided informed consent form.
Exclusion Criteria:
- incomplete clinical data;
- having a physical disability or other diseases that affect the limb function;
- having cognitive impairment or other diseases that interfere with participation;
- having serious cardiopulmonary dysfunction or another disease that requires absolute bed rest;
- having progressive stroke or having severe complications that patients drop the study before completion.
Sites / Locations
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Modified Barthel Index-based rehabilitation nursing program
Usual care
Arm Description
Patients received the Modified Barthel Index based rehabilitation nursing from qualified nurses.
Patients received the usual care.
Outcomes
Primary Outcome Measures
Change from baseline the Modified Barthel Index (MBI) on day 7
The MBI score ranges from 0 to 100, the higher scores mean a better outcome.
Change from baseline the motor assessment scale (MAS) on day 7
The MAS scale excluding general tonus, may be summed to provide an overall score out of a possible 48 points and the higher scores mean a better outcome.
Change from baseline the National Institute of Health Stroke Scale (NIHSS) on day 7
The NIHSS scale ranges from 0 to 42, and the higher scores mean a worse outcome.
Secondary Outcome Measures
The completion rate
The completion means participants completed all the study stage and all the data collection.
The adverse events rate
The adverse events including pneumonia, stroke progression or recurrent, fall.
Full Information
NCT ID
NCT04402736
First Posted
May 16, 2020
Last Updated
November 9, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT04402736
Brief Title
Feasibility and Effectiveness of Rehabilitation Nursing for Acute Stroke
Official Title
Feasibility and Effectiveness of a Modified Barthel Index-based Rehabilitation Nursing Program for Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
January 4, 2018 (Actual)
Primary Completion Date
October 29, 2018 (Actual)
Study Completion Date
November 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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
In the clinical setting, it is difficult to obtain effective rehabilitation during the acute phase, the reasons may include insufficient awareness of early rehabilitation due mainly to a limitation in number and variety of rehabilitation professionals in Low- and middle-income countries. It is necessary to shift tasks to other healthcare providers who are trained to provide rehabilitation like nurses. The purpose of this study is to examine the feasibility and effectiveness of a modified Barthel Index based rehabilitation nursing program on acute stroke inpatients.
Detailed Description
Ischemic stroke is the main cause of disability in the world. More than 70% of stroke patients show various degrees of neural function impairment. Early rehabilitation in acute phase is beneficial for improving patient's activity of daily livings and motor function. However, it is difficult to obtain effective rehabilitation during the acute phase of stroke because of the insufficiency of professional rehabilitation therapists in stroke wards in China. The investigators assume that implementing program based on modified Barthel Index can realize nursing-directed motor rehabilitation during acute phase of ischemic stroke. The present study is to conduct quasi-experimental research to confirm the feasibility and effectiveness of nursing-directed precision rehabilitation in acute stroke patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke, Nursing
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified Barthel Index-based rehabilitation nursing program
Arm Type
Experimental
Arm Description
Patients received the Modified Barthel Index based rehabilitation nursing from qualified nurses.
Arm Title
Usual care
Arm Type
Other
Arm Description
Patients received the usual care.
Intervention Type
Behavioral
Intervention Name(s)
The modified Barthel Index-based rehabilitation nursing program
Intervention Description
The intervention with the program based on the MBI classified function of patients into five levels, with every 20 points as a level, Each level corresponds to different training items. Training items included self-care training and training in transfer activities, sitting balance, walking, and sit-to-stand, etc. Each training session lasting at least 30 minutes, two sessions per day, for seven continuous days. During the intervention, the rehabilitation therapist's conventional treatment is not interfered.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Patients in the control group received clinical usual care including the activities of daily living assessment, early mobilization guide and health education. During the intervention, the rehabilitation therapist's conventional treatment is not interfered.
Primary Outcome Measure Information:
Title
Change from baseline the Modified Barthel Index (MBI) on day 7
Description
The MBI score ranges from 0 to 100, the higher scores mean a better outcome.
Time Frame
Day 0 and day 7
Title
Change from baseline the motor assessment scale (MAS) on day 7
Description
The MAS scale excluding general tonus, may be summed to provide an overall score out of a possible 48 points and the higher scores mean a better outcome.
Time Frame
Day 0 and day 7
Title
Change from baseline the National Institute of Health Stroke Scale (NIHSS) on day 7
Description
The NIHSS scale ranges from 0 to 42, and the higher scores mean a worse outcome.
Time Frame
Day 0 and day 7
Secondary Outcome Measure Information:
Title
The completion rate
Description
The completion means participants completed all the study stage and all the data collection.
Time Frame
Day 7
Title
The adverse events rate
Description
The adverse events including pneumonia, stroke progression or recurrent, fall.
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosed with ischemic stroke and met the diagnostic criteria of the World Health Organization;
initial stroke within seven days, with limb dysfunction;
NIHSS scale consciousness scores of 0 or 1;
provided informed consent form.
Exclusion Criteria:
incomplete clinical data;
having a physical disability or other diseases that affect the limb function;
having cognitive impairment or other diseases that interfere with participation;
having serious cardiopulmonary dysfunction or another disease that requires absolute bed rest;
having progressive stroke or having severe complications that patients drop the study before completion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jingfen Jin, Master
Organizational Affiliation
The Second Affiliated Hospital of Medical College of Zhejiang University
Official's Role
Study Director
Facility Information:
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
12. IPD Sharing Statement
Learn more about this trial
Feasibility and Effectiveness of Rehabilitation Nursing for Acute Stroke
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