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Original Research

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

ORCID Icon, , , ORCID Icon, , , & show all
Pages 1173-1184 | Published online: 21 Jun 2021

Figures & data

Figure 1 Flow chart of participants.

Abbreviations: mITT, modified intention-to-treat, all participants followed the random allocation with outcome data; PP, per-protocol, participants followed the random allocation with outcome data and attending the final outcome assessment.
Figure 1 Flow chart of participants.

Table 1 Baseline Demographic and Clinical Characteristics Between Groups

Table 2 Between-Group Difference on Primary Outcomes After 7 Days Treatment (PP Analysis, n=200)

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.

Notes: Data are means (symbols) and 95% CIs (error bars) for the primary outcome difference (T-C) between nurse-led (the test group, T) and therapist-led (the control group, C) rehabilitation after seven days of treatment. The dotted lines represent the non-inferiority margins (δ).
Abbreviations: MAS, Motor Assessment Scale, δ = −6.94; FMA, Fugl-Meyer Assessment, δ = −12; ARAT, Action Research Arm Test, δ = −10.
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.

Table 3 Median (IQR) Secondary Outcomes Scores for Each Group, and Results of GEE Analysis (PP Analysis, n = 200; Experimental Group n = 105, Control Group n = 95)