Feasibility and Effectiveness of Rehabilitation Nursing for Acute Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

Feasibility and Effectiveness of a Modified Barthel Index-based Rehabilitation Nursing Program for Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04402736
• Other study ID #: 2018LS112
• Status: Completed
• Phase: N/A
• Start date: January 4, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: May 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: November 20, 2018
• Est. primary completion date: October 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Nursing
• Stroke

Intervention

Behavioral:
• The modified Barthel Index-based rehabilitation nursing program
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.
• Usual care
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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0 and day 7
Primary	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.	Day 0 and day 7
Primary	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.	Day 0 and day 7
Secondary	The completion rate	The completion means participants completed all the study stage and all the data collection.	Day 7
Secondary	The adverse events rate	The adverse events including pneumonia, stroke progression or recurrent, fall.	Day 7