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

• ClinicalTrials.gov Identifier: NCT04778852
• Recruitment Status: Recruiting
• First Posted: March 3, 2021
• Last Update Posted: May 10, 2023
• Sponsor: University of Padova
• Collaborators: Fresco Parkinson Center Villa Margherita, Vicenza, Italy; Fresco Institute for Parkinson's & Movement Disorders, NYU Langone
• Information provided by (Responsible Party): ZIMI SAWACHA., University of Padova

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Device: Experimental: EksoGT; Other: Functional kinematic training	Not Applicable

Detailed Description:

Full Title: QUANTITATIVE ASSESSMENT OF TRAINING EFFECTS USING A WEARABLE EXOSKELETON IN PARKINSON DISEASE PATIENTS

RESEARCH PLAN

Specific Aims

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 proposed 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. Human movement analysis quantitatively assesses the neuromuscular and biomechanical features of movement. Recent literature has highlighted the benefit of coupling gait analysis (GA) and neuromusculoskeletal modeling (NMSM) for treatment planning and supplementing this approach with robotic rehabilitation. Another stalwart of PD research has been electroencephalography (EEG), which is widely used to evaluate executive dysfunction while functional magnetic resonance imaging (fMRI) can detect cortical changes in motor activations during motor tasks. 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. As health care professionals and researchers need objective, reliable, and valid tools to plan subject-specific interventions, quantify therapeutic outcomes, and monitor change over time, the proposed study includes estimation of neutrally-informed muscle forces and joint stiffness, which is expected to provide sensitive determinants of PD movement control that could be crucial to inform treatment planning/assessment. Preliminary data are available and showed feasibility of the proposed measurement set up.

Background OWET: Although studies have already shown the many benefits of robotic-assisted gait training in PD patients (i.e. body weight supported treadmill training) as improving gait efficiency modifying spatiotemporal (ST) parameters, these strategies create an environment where the patient has less control over the gait initiation and lacks in variability of visuospatial flow. Therefore, research focusing on optimal rehabilitation methods has been directed towards powered lower-limb exoskeleton, as in post-stroke rehabilitation, where the effect of such a treatment dramatically enhanced potential for patient-specific rehabilitation, showing improvement in ST parameters. Combining the advantages delivered from the grounded robotic devices with the ability to train the patient in a real-world environment, these systems provide a greater level of subject participation for maintaining trunk and balance control, as well as navigating their path over different surfaces and increase subject's functional abilities while the wearable robotic system guarantees less support. Furthermore, the stability the exoskeleton addresses to the patient, allows a hands-free walking trial (with no clutches) which represents an integral part for a physiological locomotion restoration.

As gait involves both CNS and PNS, targeted rehabilitation must restore not only mechanics (speed, stride time and length) but also physiological gait pattern. This requires improvements at the level of both balance and lower limb joint motion. In this direction, wearable lower-limb powered exoskeletons promote functional training in a realistic walking-environment combined with a greater patient's engagement than in grounded devices. Human movement analysis quantitatively assesses the neuromuscular and biomechanical features of movement. Recent literature has highlighted the benefit of coupling GA and NMSM for treatment planning and supplementing this approach with robotic rehabilitation, however there is no study investigating gait effects from an OWET in those with PD, and no assessment that uses comprehensive GA and NMSM to reveal mechanistic changes as a result of therapy.

Neurophysiology of PD: A stalwart of PD research has been EEG, which is widely used to evaluate executive dysfunction while fMRI can detect cortical changes in motor activations during motor tasks. The protocol to use GA in combination with fMRI has already been adopted by the investigators in order to display the impacts of the rehabilitation process on the reorganization of the neural network, describing and quantifying the neural activity and the recovery after the treatment.

Motion analysis in PD: Gait in people with PD has been thoroughly studied with 3D GA systems in recent years, documenting a typical hypokinetic gait reduction of the stride-length with asymmetry between the strides, an increment of the cadence, the stance and double support phases, which compensates for the reduced stride length.

NMSM: Combining GA and NMSM enables one to track disease progression with enhanced precision. This has been demonstrated across a range of neuromuscular pathologies and healthy individuals. Critically, for each individual a neuromusculoskeletal model is created, driven by the individual's own EMG signals, and tracking their biomechanics, as has recently applied in neurologically impaired individuals. This creates a novel model that links in vivo neuromuscular functions to the individual, thus providing new biomarkers to assess and track PD motor impairment. Furthermore, since joint stiffness depends both on neural recruitment and mechanical properties, it is likely to provide a potent representation of neural and musculoskeletal PD impairment.

Significance and potential impact This project addresses the potential for OWET to restore normal gait in PD patients. OWET aims to improve overall body motion and lower joint stiffness in those with PD, thereby improving function, quality of life, and reducing risk of injurious falls. The proposed robotic device (Ekso GT™, EksoBionics, Richmond, CA, USA) relies functions by providing passive assistance to the ankle joint, which affects the rest of the body through mechanical coupling. Currently, the amount of device assistance is estimated based on a therapist experience and expertise. Modern motion analysis methods enable us to objectively assess the required assistance providing a means to tailor the assistance to each individual and remove the risks of clinical guesswork. Robotic devices assist the physical therapist by providing task-specific repeatable mechanical action to support therapies and enable higher intensity of training. OWET aims to reduce lower limb joint stiffness, which is a recognized biomarker of PD, thereby enhancing rehabilitation for PD patients.

Findings linked with the proposed study will likely give substantial solutions to the management of gait and postural disorders (posture, balance, and gait) in PD where valid interventions (pharmacological, neurosurgery, traditional physiotherapy) are lacking. Moreover, a NMSM that identifies patient-specific variables for therapy could be used to assess treatment outcomes but also to conduct on-line rehabilitation therapy by means remote control of the assistive device. This will provide a number of advantages over conventional approaches proposing an active treatment that is personalized and scalable to large populations and including a standardized training environment and an adaptable support that has the ability to increase the treatment intensity and dose, without being a burden on therapists. OWET is thus an ideal means to complete conventional therapy in clinic, while rehabilitation robots bear the potential for continued home therapy using simpler devices.

Study design The study will be carried out over 36 months. Patients with clinically established diagnosis of PD according to the U.K. Parkinson's Disease Society Brain Bank Diagnostic criteria will be recruited. The diagnosis will be reviewed by a neurologist specialized on movement disorders. Briefly, 50 patients with mild to moderate disease severity, will be enrolled according to the inclusion\exclusion criteria included in the dedicated section below.

The activities will be organized into 4 work packages (WP), each with measurable outputs verified by scheduled deliverables/milestones.

• WP1: Clinical Trial. The sample size has been defined based on published data of gait velocity in PD subjects, and a target sample of fifty PD individuals (divided in two separate cohorts) has been selected to achieve a power of at least 80% for detecting a mean group differences in mean gait velocity (p = 0.05). One cohort (n=25) will undergo a multidisciplinary intensive rehabilitation treatment, and the other will be treated with OWET. At baseline (T0) subjects will undergo neurophysiological evaluation (EEG-fMRI) and GA. Participants will then undergo an 8-weeks OWET. After the therapy (T1), the subjects will be evaluated, with the same protocol as at T0. After another 2 months, a follow-up (T2) will be conducted using the same protocol as T0.
• WP2: Motion analysis. State-of-the-art posture and GA will be performed pre- and post-rehabilitation.
• WP3: NMSM. Using the data collected in WP1 and WP2, NMSM will be performed to obtain muscular force and joint stiffness. This NMSM will be used to assess PD neuromuscular function pre- and post-rehabilitation.
• WP4: Neurophysiological assessment. A 256 channel High Density EEG (HD-EEG) recordings and analysis will be used to assess brain oscillation activity changes before and after the treatment. Multimodal brain imaging will be performed by simultaneous acquisition and analysis of neurophysiological signals (EEG/EMG) and fMRI data to assess the resting state connectivity and activation differences between pre- and post-treatment and to identify if the changes in the cortical activity is linked with the changes detected in WP3.

Anticipated Results Locomotor functions are positively recovered by a functional gait training. Indeed, in post-stroke subjects, patients who underwent this therapy have already shown to be more likely to achieve an independent walking than people who did not receive the same treatment.

OWET will improve quality of gait and balance. Effects with OWET will impact the quality of life. The results with OWET will provide innovative information for rehabilitative programs. The impact of the intervention will be assessed by measurable outcomes listed in the dedicated section below.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Quantitative Assessment of Training Effects Using a Wearable Exoskeleton in Parkinson Disease Patients
• Actual Study Start Date: June 12, 2020
• Actual Primary Completion Date: June 12, 2022
• Estimated Study Completion Date: December 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: EksoGT; Device: EksoGT. EksoGT is an overground wearable gait trainer. The therapy will be carried out 3 days a week for 4 weeks.	Device: Experimental: EksoGT; EksoGT is an overground wearable gait trainer. The therapy will be carried out 3 days a week for 4 weeks.
Active Comparator: 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.	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.

Outcome Measures

Primary Outcome Measures :

1. Change in joint kinematics after 30 days [ Time Frame: Day 30 ]
   Joint kinematics (degrees): trunk, pelvis, hip, knee, ankle (flexion-extension, ab-adduction, internal - external rotation)
2. Change in joint kinematics after 60 days [ Time Frame: Day 60 ]
   Joint kinematics (degrees): trunk, pelvis, hip, knee, ankle (flexion-extension, ab-adduction, internal - external rotation)
3. Change in Spatiotemporal parameters after 30 days - Gait velocity [ Time Frame: Day 30 ]
   Gait velocity (meters/seconds)
4. Change in Spatiotemporal parameters after 60 days - Gait velocity [ Time Frame: Day 60 ]
   Gait velocity (meters/seconds)
5. Change in Spatial parameters after 30 days [ Time Frame: Day 30 ]
   Step width (meters), step length (meters)
6. Change in Spatial parameters after 60 days [ Time Frame: Day 60 ]
   Step width (meters), step length (meters)
7. Change in Temporal parameters after 30 days [ Time Frame: Day 30 ]
   Step duration (seconds), gait period (seconds),stance period (seconds), swing period (seconds), double support (seconds)
8. Change in Temporal parameters after 60 days [ Time Frame: Day 60 ]
   Step duration (seconds), gait period (seconds),stance period (seconds), swing period (seconds), double support (seconds)
9. Change in Spatiotemporal parameters after 30 days - Cadence [ Time Frame: Day 30 ]
   Cadence (steps/minute)
10. Change in Spatiotemporal parameters after 60 days - Cadence [ Time Frame: Day 60 ]
    Cadence (steps/minute)
11. Change in balance after 30 days - center of pressure spatial parameters [ Time Frame: Day 30 ]
    Balance during Romberg Test. From the center of pressure (COP) the following parameters will be extracted: mean distance from centre of COP trajectory (mm), root mean square of COP time series (mm), sway path, total COP trajectory length (mm), range of COP displacement (mm).
12. Change in balance after 60 days - center of pressure spatial parameters [ Time Frame: Day 60 ]
    Balance during Romberg Test. From the center of pressure (COP) the following parameters will be extracted: mean distance from centre of COP trajectory (mm), root mean square of COP time series (mm), sway path, total COP trajectory length (mm), range of COP displacement (mm)
13. Change in balance after 30 days - center of pressure velocity [ Time Frame: Day 30 ]
    Balance during Romberg Test. From the center of pressure (COP) the following parameters will be extracted: mean COP velocity (mm/s)
14. Change in balance after 60 days - center of pressure velocity [ Time Frame: Day 60 ]
    Balance during Romberg Test. From the center of pressure (COP) the following parameters will be extracted: mean COP velocity (mm/s)
15. Change in balance after 30 days - center of pressure frequency [ Time Frame: Day 30 ]
    Balance during Romberg Test. From the center of pressure (COP) the following parameters will be extracted: mean frequency (Hz), i.e., number, per second, of loops that have to be run by COP to cover total trajectory equal to sway path ; median frequency (Hz), frequency below which 50% of total power is present; 95% power frequency (Hz), frequency below which 95% of total power is present, centroidal frequency (Hz), frequency at which spectral mass is concentrated.
16. Change in balance after 60 days - center of pressure frequency [ Time Frame: Day 60 ]
    Balance during Romberg Test. From the center of pressure (COP) the following parameters will be extracted: mean frequency (Hz), i.e., number, per second, of loops that have to be run by COP to cover total trajectory equal to sway path ; median frequency (Hz), frequency below which 50% of total power is present; 95% power frequency (Hz), frequency below which 95% of total power is present, centroidal frequency (Hz), frequency at which spectral mass is concentrated.
17. Change in balance after 30 days - center of pressure ellipse parameters [ Time Frame: Day 30 ]
    Balance during Romberg Test. From the center of pressure (COP) the following parameters will be extracted: area of 95% confidence circumference (mm^2), area of 95% confidence ellipse (mm^2).
18. Change in balance after 60 days - center of pressure ellipse parameters [ Time Frame: Day 60 ]
    Balance during Romberg Test. From the center of pressure (COP) the following parameters will be extracted: area of 95% confidence circumference (mm^2), area of 95% confidence ellipse (mm^2).
19. Change in balance after 30 days - center of pressure sway area [ Time Frame: Day 30 ]
    Balance during Romberg Test. From the center of pressure (COP) the following parameters will be extracted: sway area, computed as area included in COP displacement per unit of time (mm^2/seconds).
20. Change in balance after 60 days - center of pressure sway area [ Time Frame: Day 60 ]
    Balance during Romberg Test. From the center of pressure (COP) the following parameters will be extracted: sway area, computed as area included in COP displacement per unit of time (mm^2/seconds).
21. Change in muscle forces after 30 days [ Time Frame: Day 30 ]
    Musculotendon forces estimated via musculoskeletal modeling (OpenSim, CEINMS)
22. Change in muscle forces after 60 days [ Time Frame: Day 60 ]
    Musculotendon forces estimated via musculoskeletal modeling (OpenSim, CEINMS)

Secondary Outcome Measures :

1. Change in Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) after 30 days [ Time Frame: Day 30 ]
   MDS-UPDRS in all its four components (0 no disability - 199 total disability)
2. Change in Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) after 60 days [ Time Frame: Day 60 ]
   MDS-UPDRS in all its four components (0 no disability - 199 total disability)
3. Change in Timed Up and Go test (TUG) after 30 days [ Time Frame: Day 30 ]
   Timed Up and Go test (TUG) (>= 12 seconds risk of falling).
4. Change in Timed Up and Go test (TUG) after 60 days [ Time Frame: Day 60 ]
   Timed Up and Go test (TUG) (>= 12 seconds risk of falling).
5. Change in Berg Balance Scale (BBS) after 30 days [ Time Frame: Day 30 ]
   Berg Balance Scale (BBS) (56 functional balance, < 45 greater risk of falling).
6. Change in Berg Balance Scale (BBS) after 60 days [ Time Frame: Day 60 ]
   Berg Balance Scale (BBS) (56 functional balance, < 45 greater risk of falling).
7. Change in Falls Efficacy Scale (FES) after 30 days [ Time Frame: Day 30 ]
   Falls Efficacy Scale (FES) (16 severe concern about falling - 64 no concern about falling).
8. Change in Falls Efficacy Scale (FES) after 60 days [ Time Frame: Day 60 ]
   Falls Efficacy Scale (FES) (16 severe concern about falling - 64 no concern about falling).
9. Change in 6 minutes walking test (6-WT) after 30 days [ Time Frame: Day 30 ]
   6 minutes walking test (6-WT) (min 311 meters - max 673 meters)
10. Change in 6 minutes walking test (6-WT) after 60 days [ Time Frame: Day 60 ]
    6 minutes walking test (6-WT) (min 311 meters - max 673 meters)
11. Change in Ziegler Protocol for the assessment of Freezing of Gait (FOG) severity after 30 days [ Time Frame: Day 30 ]
    Ziegler Protocol for the assessment of FOG severity (0 no festination, no FOG - 1 festination - 2 FOG).
12. Change in Ziegler Protocol for the assessment of Freezing of Gait (FOG) severity after 60 days [ Time Frame: Day 60 ]
    Ziegler Protocol for the assessment of FOG severity (0 no festination, no FOG - 1 festination - 2 FOG).
13. Change The New Freezing of Gait Questionnaire (N-FOGQ) severity after 30 days [ Time Frame: Day 30 ]
    The New Freezing of Gait Questionnaire (N-FOGQ) (0 never happened, 4 unable to walk for more than 30s).
14. Change The New Freezing of Gait Questionnaire (N-FOGQ) severity after 60 days [ Time Frame: Day 60 ]
    The New Freezing of Gait Questionnaire (N-FOGQ) (0 never happened, 4 unable to walk for more than 30s).
15. Change in neurophysiological assessment after 30 days : electromyography (EMG) [ Time Frame: Day 30 ]
    Magnitude (milliVolt)
16. Change in neurophysiological assessment after 60 days : electromyography (EMG) [ Time Frame: Day 60 ]
    Magnitude (milliVolt)
17. Change in neurophysiological assessment after 30 days : electroencephalogram (EEG) [ Time Frame: Day 30 ]
    Spectral parameters (Hz)
18. Change in neurophysiological assessment after 60 days : electroencephalogram (EEG) [ Time Frame: Day 60 ]
    Spectral parameters (Hz)
19. Change in neurophysiological assessment after 30 days : functional Magnetic Resonance Imaging (fMRI) [ Time Frame: Day 30 ]
    Number of active voxel in the region of interest
20. Change in neurophysiological assessment after 60 days : functional Magnetic Resonance Imaging (fMRI) [ Time Frame: Day 60 ]
    Number of active voxel in the region of interest

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Patient with rigid-acinetic bilateral PD form
• Hoehn-Yahr between 3-4
• At least 4 years of disease history
• Stable drug therapy response without any change performed in the 3 months before the study
• Presence of freezing (FOG) and of postural instability not responding to parkinsonian therapy
• Mini Mental State Evaluation > 24/30

Exclusion Criteria:

• Systemic illness
• Presence of cardiac pacemaker
• Postural abnormalities, orthopedic comorbidities that do not match the active physiotherapy treatment
• Presence of deep brain stimulation
• Presence of severe disautonomia with marked hypotension
• Obsessive-Compulsive disorder (OCD)
• Major depression
• Dementia and psychosis
• History or active neoplasia
• Pregnancy
• Other criteria that do not respect the device counterindications

Contacts and Locations

Contacts

Contact: Zimi Sawacha, PhD; +39 0498277633; zimi.sawacha@dei.unipd.it

Contact: Marco Romanato, MSEng; +39 0498277805; romanato@dei.unipd.it

Locations

Italy

University of Padova; Recruiting

Padova, Italy, 35128

Contact: zimi sawacha, PhD +39 0498277633 zimi.sawacha@dei.unipd.it

Contact: marco romanato, MSEng +39 0498277805 romanato@dei.unipd.it

Fresco Parkinson Center, Villa Margherita; Recruiting

Vicenza, Italy, 36057

Contact: Daniele Volpe, MD daniele.volpe@casadicuravillamargherita.it

Sponsors and Collaborators

University of Padova

Fresco Parkinson Center Villa Margherita, Vicenza, Italy

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

Investigators

• Principal Investigator: Zimi Sawacha, PhD; University of Padova

More Information

Additional Information:

Dennis R. Louie, Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review 

A De Luca, Exoskeleton for Gait Rehabilitation: Effects of Assistance, Mechanical Structure, and Walking Aids on Muscle Activations 

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• Responsible Party: ZIMI SAWACHA., Associate Professor, University of Padova
• ClinicalTrials.gov Identifier: NCT04778852
• Other Study ID Numbers: EKSO_PD Protocol number 55-20
• First Posted: March 3, 2021
• Last Update Posted: May 10, 2023
• Last Verified: May 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by ZIMI SAWACHA., University of Padova:

Parkinson Disease; rehabilitation exhoskeleton; gait analysis; fMRI; Electroencephalogram

Additional relevant MeSH terms:

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases