Abstract
BACKGROUND: For effective rehabilitation after stroke, it is essential to conduct an objective assessment of the patient's functional status. Several stroke severity scales have been used for this purpose, but such scales have various limitations. OBJECTIVE: Gait analysis using smart insole technology can be applied continuously, objectively, and quantitatively, thereby overcoming the shortcomings of other assessment tools. METHODS: To confirm the reliability of gait analysis using smart insole technology, normal healthy controls wore insoles in their shoes during the Timed Up and Go (TUG) test. The gait parameters were compared with the manually collected data. To determine the gait characteristics of patients with hemiplegia due to stroke, they were asked to wear insoles and take the TUG test; gait parameters were calculated and compared with those of control subjects. To investigate whether the gait analysis accurately reflected the patients' clinical condition, we analyzed the relationships of 22 gait parameters on 4 stroke severity scales. RESULTS: The smart insole gait parameter data were similar to those calculated manually. Among the 18 gait parameters tested, 14 were significantly effective at distinguishing patients from healthy controls. The smart insole data revealed that the stance duration on both sides was longer in patients than controls, which has proven difficult to show using other methods. Furthermore, the sound side in patients showed a markedly longer stance duration. Regarding swing duration, that of the sound side was shorter in patients than controls, whereas that of the hemiplegic side was longer. We identified 10 significantly correlated gait parameters on the stroke severity scales. Notably, the difference in stance duration between the sound and hemiplegic sides was significantly correlated with the Fugl-Meyer Assessment (FMA) lower extremity score. CONCLUSIONS: This study confirmed the feasibility and applicability of the smart insole as a device to assess the gait of patients with hemiplegia due to stroke. In addition, we demonstrated that the FMA score was significantly correlated with the smart insole data. Providing an environment where stroke patients can easily measure walking ability helps to maintain chronic functions as well as acute rehabilitation. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000041646, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047538.