Clinical trial NCT04402736: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Nursing
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change from baseline the Modified Barthel Index (MBI) on day 7
timeFrame: Day 0 and day 7
measure: Change from baseline the motor assessment scale (MAS) on day 7
timeFrame: Day 0 and day 7
measure: Change from baseline the National Institute of Health Stroke Scale (NIHSS) on day 7
timeFrame: Day 0 and day 7
Secondary outcomes:
measure: The completion rate
timeFrame: Day 7
measure: The adverse events rate
timeFrame: Day 7
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: The Second Affiliated Hospital of Medical College of Zhejiang University
name: Jingfen Jin, Master
role: STUDY_DIRECTOR
References: