A wearable system for visual cueing gait rehabilitation in Parkinson's disease: a randomized non-inferiority trial

Abstract

BACKGROUND Gait disturbances represent one of the most disabling features of Parkinson’s disease (PD). AIM The aim of this study was to evaluate the non-inferiority of a new wearable visual cueing system (Q-Walk) for gait rehabilitation in PD subjects, compared to traditional visual cues (stripes on the floor). DESIGN Open-label, monocentric, randomized controlled non-inferiority trial. SETTING Outpatients. POPULATION Patients affected by idiopathic PD without cognitive impairment, Hoehn and Yahr stage II-IV, Unified Parkinson’s Disease Rating Scale motor section III ≥2, stable drug usage since at least 3 weeks. METHODS At the enrollment (T0), all subjects underwent a clinical/functional evaluation and the instrumental gait and postural analysis; then they were randomly assigned to the Study Group (SG) or Control Group (CG). Rehabilitation program consisted in 10 consecutive individual sessions (5 sessions/week for 2 consecutive weeks). Each session included 60 minutes of conventional physiotherapy plus 30 minutes of gait training by Q-Walk (SG) or by traditional visual cues (CG). Follow-up visits were scheduled at the end of the treatment (T1) and after 3 months (T2). RESULTS Fifty-two subjects were enrolled in the study, 26 in each group. The within-groups analysis showed a significant improvement in clinical scales and instrumental data at T1 and at T2, compared to baseline, in both groups. According to the between-group analysis, Q-Walk cueing system was not-inferior to the traditional cues for gait rehabilitation. The satisfaction questionnaire revealed that most subjects described the Q-Walk cueing system as simple, motivating and easily usable, possibly suitable for home use. CONCLUSIONS Data showed that motor rehabilitation of PD subjects performed by means of the new wearable Q-Walk cueing system was feasible and as effective as traditional cues in improving gait parameters and balance. CLINICAL REHABILITATION IMPACT Wearable devices can act as an additional rehabilitation strategy for long-term and continuous care, allowing patients to train intensively and extensively in household settings, favoring a tailor-made and personalized approach as well as remote monitoring.