Contemporary Clinical Trials Communications (Aug 2022)
Quantitative assessment of training effects using EksoGT® exoskeleton in Parkinson's disease patients: A randomized single blind clinical trial
Abstract
Background: Gait alterations are among the most disabling motor-symptoms associated with Parkinson's Disease (PD): reduced stride length, stride velocity and lower limb joint range of motion are hallmarks of parkinsonian gait. Research focusing on optimal functional rehabilitation methods has been directed towards powered lower-limb exoskeletons which combines the advantages delivered from the grounded robotic devices with the ability to train the patient in a real-world environment. As gait involves both central (CNS) and peripheral nervous systems (PNS), targeted rehabilitation must restore not only mechanics but also neurophysiological gait patterns. Methods: Two cohorts of subjects will be enrolled and equally distributed between one group (n = 25) who will undergo a functional kinematic therapy, and one group (n = 25) who will undergo an overground wearable-exoskeleton training. Participants are evaluated at three time points: before the therapy (T0), after the therapy (T1), 4-weeks after T1 (T2). Comprehensive gait analysis and surface electromyography will be combined into neuromusculoskeletal modelling to determine modifications at the PNS level. Functional magnetic resonance imaging coupled with electroencephalography will be used to determine modifications at the CNS level. Conclusion: The findings of the proposed trial will likely give substantial solutions for the management of gait and postural disorders in PD where valid interventions are lacking. The coupling of movement evaluation, which assesses neuromuscular and biomechanical features, with neurological data, will better define the impact of the therapy on the relationship between PD motor alterations and brain activity. This will provide an active treatment that is personalized and shared to large populations.
