Feasibility and Effectiveness of Rehabilitation Nursing for Acute Stroke

NCT04402736 | Completed

• 1 other identifier: 2018LS112
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke; Nursing

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• The completion rate

  Day 7

• The adverse events rate

  Day 7

Study Arms (2)

Modified Barthel Index-based rehabilitation nursing program

EXPERIMENTAL

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

Behavioral: The modified Barthel Index-based rehabilitation nursing program

Usual care

OTHER

Patients received the usual care.

Behavioral: Usual care

Interventions

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.

Modified Barthel Index-based rehabilitation nursing program

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.

Usual care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jingfen Jin, Master

  The Second Affiliated Hospital of Medical College of Zhejiang University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2020
• First Posted: May 27, 2020
• Study Start: January 4, 2018
• Primary Completion: October 29, 2018
• Study Completion: November 20, 2018
• Last Updated: November 12, 2020

Record last verified: 2020-05

Locations

CN (1)