Quantitative Assessment of Training Effects Using EKSOGT Exoskeleton in Quantitative Assessment of Training Effects Using EKSOGT Exoskeleton in Parkinson Disease Patients

Summary

The ability to walk independently is a primary goal when rehabilitating an individual with Parkinson Disease (PD). Indeed, PD patients display a flexed posture that coupled with an excessive joint stiffness lead to a poor walking mechanics that increase their risk of falls. Although studies have already shown the many benefits of robotic-assisted gait training in PD patients, research focusing on optimal rehabilitation methods has been directed towards powered lower-limb exoskeleton. Combining the advantages delivered from the grounded devices with the ability to train in a real-world environment, these systems provide a greater level of subject participation and increase subject's functional abilities while the wearable robotic system guarantees less support. The purpose of the present work is to evaluate the effects of an Over-ground Wearable Exoskeleton Training (OWET) on gait impairments in comparison with a multidisciplinary intensive rehabilitation treatment. As gait is a complex task that involves both central (CNS) and peripheral nervous systems (PNS), targeted rehabilitation must restore not only gait mechanics (ST parameters) but also physiological gait pattern (joint kinematics and dynamics). To this aim the impact of OWET on both CNS and PNS will be evaluated. Thus, a quantitative assessment of an individual's gait and neuromuscular function to robustly evaluate recovery of altered sensorimotor function at both the PNS and CNS is proposed. To this aim, comprehensive GA (spatiotemporal (ST) parameter, joint kinematics, joint stiffness) and electromyography (EMG) will be combined to determine PNS improvements, and fMRI with EEG will be used to assess CNS improvements.

Conditions

• Parkinson Disease

Interventions

DEVICE

Experimental: EksoGT

EksoGT is an overground wearable gait trainer. The therapy will be carried out 3 days a week for 4 weeks.

OTHER

Functional kinematic training

Device: No device. The functional kinematic training will be delivered as comparator treatment and will be carried out 3 days a week for 4 weeks.

Sponsors & Collaborators

• Fresco Parkinson Center Villa Margherita, Vicenza, Italy

  collaborator UNKNOWN

• Fresco Institute for Parkinson's & Movement Disorders, NYU Langone

  collaborator UNKNOWN

• University of Padova

  lead OTHER

Principal Investigators

• Zimi Sawacha, PhD · University of Padova

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-12

Primary Completion

2022-06-12

Completion

2023-12-31

FDA Device

Yes

Countries

• Italy

Study Locations