RESUMO
Reducing energy consumption during walking is a critical goal for transtibial amputees. The study presents the evaluation of a semi-active prosthesis with five transtibial amputees. The prosthesis has a low-power actuator integrated in parallel into an energy-storing-and-releasing foot. The actuator is controlled to compress the foot during the stance phase, supplementing the natural compression due to the user's dynamic interaction with the ground, particularly during the ankle dorsiflexion phase, and to release the energy stored in the foot during the push-off phase, to enhance propulsion. The control strategy is adaptive to the user's gait patterns and speed. The clinical protocol to evaluate the system included treadmill and overground walking tasks. The results showed that walking with the semi-active prosthesis reduced the Physiological Cost Index of transtibial amputees by up to 16% compared to walking using the subjects' proprietary prosthesis. No significant alterations were observed in the spatiotemporal gait parameters of the participants, indicating the module's compatibility with users' natural walking patterns. These findings highlight the potential of the mechatronic actuator in effectively reducing energy expenditure during walking for transtibial amputees. The proposed prosthesis may bring a positive impact on the quality of life, mobility, and functional performance of individuals with transtibial amputation.
Assuntos
Amputados , Membros Artificiais , Humanos , Articulação do Tornozelo/fisiologia , Fenômenos Biomecânicos , Marcha/fisiologia , Desenho de Prótese , Qualidade de Vida , Caminhada/fisiologiaRESUMO
Background: Intensive treadmill training (TT) has been documented to improve gait parameters and functional independence in Parkinson's Disease (PD), but the optimal intervention protocol and the criteria for tailoring the intervention to patients' performances are lacking. TT may be integrated with augmented virtual reality (AVR), however, evidence of the effectiveness of this combined treatment is still limited. Moreover, prognostic biomarkers of rehabilitation, potentially useful to customize the treatment, are currently missing. The primary aim of this study is to compare the effects on gait performances of TT + AVR versus TT alone in II-III stage PD patients with gait disturbance. Secondary aims are to assess the effects on balance, gait parameters and other motor and non-motor symptoms, and patient's satisfaction and adherence to the treatment. As an exploratory aim, the study attempts to identify biomarkers of neuroplasticity detecting changes in Neurofilament Light Chain concentration T0-T1 and to identify prognostic biomarkers associated to blood-derived Extracellular Vesicles. Methods: Single-center, randomized controlled single-blind trial comparing TT + AVR vs. TT in II-III stage PD patients with gait disturbances. Assessment will be performed at baseline (T0), end of training (T1), 3 (T2) and 6 months (T3, phone interview) from T1. The primary outcome is difference in gait performance assessed with the Tinetti Performance-Oriented Mobility Assessment gait scale at T1. Secondary outcomes are differences in gait performance at T2, in balance and spatial-temporal gait parameters at T1 and T2, patients' satisfaction and adherence. Changes in falls, functional mobility, functional autonomy, cognition, mood, and quality of life will be also assessed at different timepoints. The G*Power software was used to estimate a sample size of 20 subjects per group (power 0.95, α < 0.05), raised to 24 per group to compensate for potential drop-outs. Both interventions will be customized and progressive, based on the participant's performance, according to a predefined protocol. Conclusion: This study will provide data on the possible superiority of AVR-associated TT over conventional TT in improving gait and other motor and non-motor symptoms in persons with PD and gait disturbances. Results of the exploratory analysis could add information in the field of biomarker research in PD rehabilitation.