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Jianmiao Wang,1 Yuping Zhang,1 Yuanyuan Chen,2 Mei Li,1 Hongyan Yang,2 Jinhua Chen,2 Qiaomin Tang,2 Jingfen Jin1,3
1Nursing
Department, The Second Affiliated Hospital of Zhejiang University
School of Medicine, Hangzhou, Zhejiang Province, People’s Republic of
China; 2Neurology Department, The Second Affiliated Hospital
of Zhejiang University School of Medicine, Hangzhou, Zhejiang Province,
People’s Republic of China; 3Changxing Branch Hospital, The
Second Affiliated Hospital of Zhejiang University School of Medicine,
Huzhou, Zhejiang Province, People’s Republic of China
Correspondence: Jingfen Jin
The
Second Affiliated Hospital of Zhejiang University School of Medicine,
No. 88 Jiefang Road, Shangcheng District, Hangzhou, Zhejiang Province,
310009, People’s Republic of China
Fax +86-0571-87783778
Email zrjzkhl@zju.edu.cn
Purpose:
To determine the effectiveness of rehabilitation nursing program interventions in patients with acute ischemic stroke.
Patients and Methods:
An assessment-blinded randomized controlled trial was conducted at a
tertiary referral hospital in China. Eligible patients were stratified
according to their weighted corticospinal tract lesion load and then
randomly assigned to an experimental group (n = 121) or a control group
(n = 103). The experimental group received rehabilitation nursing from
well-trained, qualified nurses (30 minutes per session, two sessions per
day for seven consecutive days). The control group received
therapist-led rehabilitation with the same timing and frequency.
Comparative analysis of the primary outcomes was performed to determine
non-inferiority with a predetermined non-inferiority margin. The primary
outcomes were the Motor Assessment Scale, Fugl-Meyer Assessment, and
the Action Research Arm Test assessed at baseline and after seven days
of treatment. The secondary outcomes were the modified Barthel Index,
the National Institutes of Health Stroke Scale, and the modified Rankin
Scale, evaluated before and after the intervention and at 4 and 12 weeks
of follow-up.
Results:
Two hundred participants
completed the trial. In both groups, all outcomes improved significantly
after seven days and at follow-ups. The rehabilitation nursing program
was non-inferior to therapist-led treatment with lower 95% confidence
limits beyond the margins for primary outcomes (P < 0.001).
Conclusion:
Both treatments had comparable effects; however, no definite conclusion
could be drawn. Adequately powered studies are required.
Keywords: rehabilitation, nursing, acute ischemic stroke, motor function
Introduction
Stroke is the leading cause of mortality and disability worldwide;
87% of all deaths from stroke and 89% of all stroke-related
disability-adjusted life-years occur in low- and middle-income countries
(LMICs).1
In contrast to the global downward trend, the incidence is rising in
LMICs, with approximately 2.4 million new stroke cases each year in
China; more than one-third of acute ischemic stroke (AIS) patients die
or become disabled within three months or one year.2 The high risk of disability and dysfunction may be related to the aging of the population.3 By 2050, one in six people in the world will be 65 years of age or older.4 COVID-19-related ischemic stroke leads to worse functional outcomes and higher mortality.5
Secondary stroke risk increased not only because of the disease
characteristics of COVID-19 but also because of lack of physical
activity due to isolation or restriction of access to treatments.6
Due to limited medical resources and isolation policies, access to
services has been significantly reduced, and the burden of disability
has increased further.
The functional limitations of the trunk and limbs associated with
stroke reduce the ability to participate in activities of daily living
(ADLs), requiring assistance with eating, drinking, moving, toileting,
performing personal hygiene tasks, dressing, and grooming,7 which seriously affects the quality of life of stroke patients.8
The severity and variety of disorders in patients after stroke relate
to the site and infarct size, and motor dysfunction is the principal
problem. The leading causes are damage to the corticospinal tract (CST)
and brain motor centers.9
The CST is the most critical motor control pathway that affects motor
function recovery and outcome from a stroke. Motor function training in
the acute stage (within the first two weeks10) can increase the structural integrity of the ipsilesional CST.11
After a stroke, rehabilitation is essential to help survivors achieve
an optimal functional level and prevent or delay future functional
decline.12 In the first days and weeks, the brain responds most quickly to the stimulus of motor training;13
In appropriate amounts, early training aids recovery and improves
outcomes and quality of life. Early rehabilitation interventions in
acute care settings are critical to optimizing the recovery potential in
repair windows and prevent various complications secondary to the
disability. Guidelines recommend providing early rehabilitation services
for hospitalized stroke patients in an organized, multi-professional
stroke care environment.10,14
Nevertheless, there are few practice guidelines or clinical pathways,
and published guidelines do not guarantee effective implementation in
practice.15
There are gaps between the best evidence and current practice that are
not conducive to clinical intervention implementation or patient
benefits. The consensus reached in the second stroke recovery and
rehabilitation roundtable was to determine knowledge translation
priorities and take specific actions to deal with the practice gaps.16
Inadequate resources for rehabilitation services are the main reason
why clinical practices do not follow guidelines well. Many LMICs provide
some rehabilitation care in acute settings, and transitional and
community rehabilitation are rare.16
The proportion of stroke patients in LMICs receiving rehabilitation
treatment is too small, and rehabilitation or treatment within seven
days after stroke is also limited.17
Currently, there are about 10,000 rehabilitation physicians and 20,000
rehabilitation therapists in China, with an average of 1 to 2 per
100,000 people, much lower than the 40 to 70 per 100,000 in developed
countries.18
According to the World Health Organization’s Rehabilitation 2030
report, the numbers of rehabilitation practitioners, are far below those
of high-income countries, while data on rehabilitation nurses are not
available.19
Access to related rehabilitation services and staffing are systemic
issues that need to be prioritized, and it is recommended that solutions
be implemented to address these issues in the context of local
realities to improve the quality of life of stroke patients.16
In LMICs, localized measures to improve functional outcomes after
stroke with low-cost, resource-saving physical rehabilitation
interventions are possible.20 There is evidence that aerobic programs and rehabilitation assistants increase the intensity of rehabilitation.16
As part of a multidisciplinary team, nurses play critical roles in
facilitating stroke recovery, and recognizing their valuable
contributions is essential.21
Nurses provide rehabilitation services in nursing homes and community
rehabilitation centers and should also provide rehabilitation services
in the acute phase.22
Primary care nurses’ complex interventions increased the number of
objectively measured step-counts and moderate-to-intense physical
activity.23
Enrolling nurses in task-oriented training can create more
opportunities for patients to practice meaningful functional tasks
outside of their regular treatment sessions. When nurses incorporate
rehabilitation goals into nurses’ daily care, they also improve patient
independence.24
However, in current clinical practice, nurses pay more attention to
maintaining safe care and preventing potential problems, including
falls; there is limited practical nursing evidence in the vital areas,
including mobility.25
There is no consensus on acute rehabilitation nursing guidelines or practice activities.26
Stroke nursing includes good limb placement, turning over, and
out-of-bed mobilization education. Rehabilitation principles should be
more integrated into practice. Because the establishment of acute
rehabilitation nursing is best customized locally to match available
resources.27
We developed a rehabilitation nursing program to improve motor
function. Due to insufficient evidence for interventions, based on
expert opinions and combined with feasibility study results, we
considered factors that facilitate or hinder implementation. The main
components of rehabilitation nursing interventions include physical
therapy (PT), occupational therapy (OT), ADLs, following the principles
of repetitive task-oriented training and patient-centered
individualization implementation, as described in our protocol.28
Our research was motivated by the question of whether rehabilitation
nursing interventions are effective, and if so, how effective are they
compared to rehabilitation provided by therapists in current practice?
While standard treatments already exist, some therapies may be safer,
more convenient, or less expensive with similar efficacy. An
educational training program for nurses improved their knowledge and
practice in clinical settings and improved ADLs and self-care abilities
for stroke patients.29
The results of the cost-effectiveness analysis provide evidence that
nursing interventions can save costs for ischemic patients.30
Patients hospitalized in the acute phase are more likely to have access
to nurses; therefore, it is possible to conduct a comparative study of
rehabilitation nursing interventions with therapies used in practice.
This trial aimed to identify an option with comparable efficacy
rather than superior efficacy. Non-inferiority trials attempt to
determine whether a new treatment is inferior to a reference treatment
and define a predetermined non-inferiority margin (δ).31
For this reason, it makes sense to use a non-inferiority trial design
when comparing the effects of nurse-led rehabilitation and therapist-led
rehabilitation. Because multidisciplinary team early rehabilitation is
the guideline-recommended treatment, it would be unethical to use a
placebo or no-treatment control in the study.32 This study could not be designed as a three-arm trial that included a blank control.
Therefore, our objective was a non-inferiority comparison between a
rehabilitation nursing intervention and a therapist-led treatment
regarding motor function assessments (the primary outcomes). Sequence
tests and secondary outcomes were assessed for superiority.