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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04402736
Enrollment
104
Registered
2020-05-27
Start date
2018-01-04
Completion date
2018-11-20
Last updated
2020-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke, Nursing

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.

Interventions

BEHAVIORALThe 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.

BEHAVIORALUsual 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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline the Modified Barthel Index (MBI) on day 7Day 0 and day 7The MBI score ranges from 0 to 100, the higher scores mean a better outcome.
Change from baseline the motor assessment scale (MAS) on day 7Day 0 and day 7The 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.
Change from baseline the National Institute of Health Stroke Scale (NIHSS) on day 7Day 0 and day 7The NIHSS scale ranges from 0 to 42, and the higher scores mean a worse outcome.

Secondary

MeasureTime frameDescription
The completion rateDay 7The completion means participants completed all the study stage and all the data collection.
The adverse events rateDay 7The adverse events including pneumonia, stroke progression or recurrent, fall.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026