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Feasibility and Effectiveness of Rehabilitation Nursing for Acute Stroke

NCT ID: NCT04402736

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-04

Study Completion Date

2018-11-20

Brief Summary

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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

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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.

Conditions

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Acute Ischemic Stroke Nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Modified Barthel Index-based rehabilitation nursing program

Patients received the Modified Barthel Index based rehabilitation nursing from qualified nurses.

Group Type EXPERIMENTAL

The modified Barthel Index-based rehabilitation nursing program

Intervention Type BEHAVIORAL

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 received the usual care.

Group Type OTHER

Usual care

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jingfen Jin, Master

Role: STUDY_DIRECTOR

The Second Affiliated Hospital of Medical College of Zhejiang University

Locations

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2018LS112

Identifier Type: -

Identifier Source: org_study_id