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

NCT04778852 | Unknown FDA Device

• 1 other identifier: EKSO_PD Protocol number 55-20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease

Keywords

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

Outcome Measures

Primary Outcomes (22)

• Change in joint kinematics after 30 days

  Joint kinematics (degrees): trunk, pelvis, hip, knee, ankle (flexion-extension, ab-adduction, internal - external rotation)

  Day 30

• Change in joint kinematics after 60 days

  Joint kinematics (degrees): trunk, pelvis, hip, knee, ankle (flexion-extension, ab-adduction, internal - external rotation)

  Day 60

• Change in Spatiotemporal parameters after 30 days - Gait velocity

  Gait velocity (meters/seconds)

  Day 30

• Change in Spatiotemporal parameters after 60 days - Gait velocity

  Gait velocity (meters/seconds)

  Day 60

• Change in Spatial parameters after 30 days

  Step width (meters), step length (meters)

  Day 30

• Change in Spatial parameters after 60 days

  Step width (meters), step length (meters)

  Day 60

• Change in Temporal parameters after 30 days

  Step duration (seconds), gait period (seconds),stance period (seconds), swing period (seconds), double support (seconds)

  Day 30

• Change in Temporal parameters after 60 days

  Step duration (seconds), gait period (seconds),stance period (seconds), swing period (seconds), double support (seconds)

  Day 60

• Change in Spatiotemporal parameters after 30 days - Cadence

  Cadence (steps/minute)

  Day 30

• Change in Spatiotemporal parameters after 60 days - Cadence

  Cadence (steps/minute)

  Day 60

• Change in balance after 30 days - center of pressure spatial parameters

  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).

  Day 30

• Change in balance after 60 days - center of pressure spatial parameters

  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)

  Day 60

• Change in balance after 30 days - center of pressure velocity

  Balance during Romberg Test. From the center of pressure (COP) the following parameters will be extracted: mean COP velocity (mm/s)

  Day 30

• Change in balance after 60 days - center of pressure velocity

  Balance during Romberg Test. From the center of pressure (COP) the following parameters will be extracted: mean COP velocity (mm/s)

  Day 60

• Change in balance after 30 days - center of pressure frequency

  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.

  Day 30

• Change in balance after 60 days - center of pressure frequency

  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.

  Day 60

• Change in balance after 30 days - center of pressure ellipse parameters

  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).

  Day 30

• Change in balance after 60 days - center of pressure ellipse parameters

  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).

  Day 60

• Change in balance after 30 days - center of pressure sway area

  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).

  Day 30

• Change in balance after 60 days - center of pressure sway area

  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).

  Day 60

• Change in muscle forces after 30 days

  Musculotendon forces estimated via musculoskeletal modeling (OpenSim, CEINMS)

  Day 30

• Change in muscle forces after 60 days

  Musculotendon forces estimated via musculoskeletal modeling (OpenSim, CEINMS)

  Day 60

Secondary Outcomes (20)

• Change in Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) after 30 days

  Day 30

• Change in Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) after 60 days

  Day 60

• Change in Timed Up and Go test (TUG) after 30 days

  Day 30

• Change in Timed Up and Go test (TUG) after 60 days

  Day 60

• Change in Berg Balance Scale (BBS) after 30 days

  Day 30

Study Arms (2)

EksoGT

EXPERIMENTAL

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

Functional kinematic training

ACTIVE COMPARATOR

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

Interventions

Experimental: EksoGT DEVICE

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

EksoGT

Functional kinematic training OTHER

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.

Functional kinematic training

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead
• Fresco Parkinson Center Villa Margherita, Vicenza, Italy: collaborator
• Fresco Institute for Parkinson's & Movement Disorders, NYU Langone: collaborator

Study Sites (2)

University of Padova

Padua, 35128, Italy

RECRUITING

Fresco Parkinson Center, Villa Margherita

Vicenza, 36057, Italy

RECRUITING

Related Publications (22)

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Related Links

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

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Zimi Sawacha, PhD

  University of Padova

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zimi Sawacha, PhD

CONTACT

+39 0498277633; zimi.sawacha@dei.unipd.it

Marco Romanato, MSEng

CONTACT

+39 0498277805; romanato@dei.unipd.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: March 3, 2021
• Study Start: June 12, 2020
• Primary Completion: June 12, 2022
• Study Completion: December 31, 2023
• Last Updated: May 10, 2023

Record last verified: 2022-05

Locations

IT (2)