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Randomized Controlled Trial
. 2021 Jun 21:16:1173-1184.
doi: 10.2147/CIA.S306255. eCollection 2021.

Effectiveness of Rehabilitation Nursing versus Usual Therapist-Led Treatment in Patients with Acute Ischemic Stroke: A Randomized Non-Inferiority Trial

Jianmiao Wang  1 , Yuping Zhang  1 , Yuanyuan Chen  2 , Mei Li  1 , Hongyan Yang  2 , Jinhua Chen  2 , Qiaomin Tang  2 , Jingfen Jin  1   3
Affiliations
Randomized Controlled Trial

Effectiveness of Rehabilitation Nursing versus Usual Therapist-Led Treatment in Patients with Acute Ischemic Stroke: A Randomized Non-Inferiority Trial

Jianmiao Wang et al. Clin Interv Aging. .

Abstract

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: acute ischemic stroke; motor function; nursing; rehabilitation.

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Conflict of interest statement

The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Flow chart of participants.
Figure 2
Figure 2
Treatment difference and non-inferiority margin. (A) Non-inferiority test for the modified intention-to-treat dataset, n = 209. (B) Non-inferiority test for the per-protocol dataset, n = 200.
See this image and copyright information in PMC

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