Obviously neither one is effective since no one talks about getting to 100% recovery. My definition of efficacy is 100% recovery, what is yours? Anything less than 100% recovery should be fireable for all involved.
Effectiveness of Rehabilitation Nursing versus Usual Therapist-Led Treatment in Patients with Acute Ischemic Stroke: A Randomized Non-Inferiority Trial
Received 15 February 2021
Accepted for publication 13 May 2021
Published 21 June 2021 Volume 2021:16 Pages 1173—1184
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Prof. Dr. Zhi-Ying Wu
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
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
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).
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
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.