Objective: To investigate the external validation of the previously reported minimal important change (MIC) in the 6-minute walk test (6MWT) and update it for patients with subacute stroke hospitalized in rehabilitation unit.
Design: Longitudinal study SETTING: : Rehabilitation unit of a neurosurgical hospital.
Participants: One hundred and seven patients with subacute stroke.
Intervention: Not applicable.
Main outcome measure(s): The 6MWT, modified Rankin Scale (mRS), Functional Ambulation Categories (FAC), and Functional Independence Measure (FIM) were assessed at 30 (baseline) and 60 (follow-up) days after stroke onset. Patients were divided into two groups according to improvements of mRS by ≥1, FAC by ≥1, or FIM by ≥22. The change in the 6MWT between baseline and follow-up was calculated and patients were divided into two groups according to improvements of 6MWT by ≥71 m. External validation was performed using likelihood ratio (LR) between change of 6MWT by ≥71 m and improvement of mRS. An LR+>2.0 and LR-<0.5 was considered valid. The new MIC of the 6MWT was calculated for the mRS, FAC, and FIM using the receiver operating characteristic curve (MICROC) and adjusted predictive modeling method (MICadjusted).
Results: No external validation was achieved (LR+ of 1.41, LR- of 0.77). The MICROC values for mRS, FAC, and FIM were 22.0 m, 69.0 m, and 22.0 m, respectively. The MICadjusted values for the mRS, FAC, and FIM were 68.7 m, 63.1 m, and 83.1 m, respectively. Only the MIC of the 6MWT for FAC was validated.
Conclusions: The previously reported MIC of the 6MWT was not suitable for patients with subacute stroke hospitalized in rehabilitation units; however, the newly determined MIC was useful.
Keywords: 6-minute walk test; Functional Ambulation Categories; Functional Independence Measure; external validity; minimal important change; modified Rankin Scale; stroke.
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