Feasibility and Effectiveness of Rehabilitation Nursing for Acute Stroke

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Ischemic Stroke; Nursing
• Intervention / Treatment: Behavioral: The modified Barthel Index-based rehabilitation nursing program; Behavioral: Usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Second Affiliated Hospital, School of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Modified Barthel Index-based rehabilitation nursing program; Patients received the Modified Barthel Index based rehabilitation nursing from qualified nurses.	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.
OTHER: Usual care; Patients received the usual care.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The completion rate	The completion means participants completed all the study stage and all the data collection.	Day 7
The adverse events rate	The adverse events including pneumonia, stroke progression or recurrent, fall.	Day 7

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 4, 2018
• Primary Completion (ACTUAL): October 29, 2018
• Study Completion (ACTUAL): November 20, 2018

Study Registration Dates

• First Submitted: May 16, 2020
• First Submitted That Met QC Criteria: May 24, 2020
• First Posted (ACTUAL): May 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: 2018LS112

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No