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Completed

NCT Number: NCT04402736

Feasibility and Effectiveness of Rehabilitation Nursing for Acute 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.

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Nursing Stroke Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The modified Barthel Index-based rehabilitation nursing program

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

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.

Primary outcomes

  1. Change from baseline the Modified Barthel Index (MBI) on day 7

    Time frame: Day 0 and day 7

    The MBI score ranges from 0 to 100, the higher scores mean a better outcome.

  2. Change from baseline the motor assessment scale (MAS) on day 7

    Time frame: Day 0 and 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.

  3. Change from baseline the National Institute of Health Stroke Scale (NIHSS) on day 7

    Time frame: Day 0 and day 7

    The NIHSS scale ranges from 0 to 42, and the higher scores mean a worse outcome.

Secondary outcomes

  1. The completion rate

    Time frame: Day 7

    The completion means participants completed all the study stage and all the data collection.

  2. The adverse events rate

    Time frame: Day 7

    The adverse events including pneumonia, stroke progression or recurrent, fall.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 27, 2020
Registry last updated
Nov 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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