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

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ClinicalTrials.gov Identifier: NCT04778852
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
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

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

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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
Estimated Primary Completion Date : June 12, 2022
Estimated Study Completion Date : June 12, 2023

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04778852


Contacts
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Contact: Zimi Sawacha, PhD +39 0498277633 zimi.sawacha@dei.unipd.it
Contact: Marco Romanato, MSEng +39 0498277805 romanato@dei.unipd.it

Locations
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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
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Principal Investigator: Zimi Sawacha, PhD University of Padova
Additional Information:
Publications:

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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    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021

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