Quantitative Assessment of Training Effects Using a Wearable Exoskeleton in Parkinson Disease Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Change in joint kinematics after 60 days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in joint kinematics after 60 days
时间窗: Day 60
Joint kinematics (degrees): trunk, pelvis, hip, knee, ankle (flexion-extension, ab-adduction, internal - external rotation)
Change in Spatiotemporal parameters after 60 days - Gait velocity
时间窗: Day 60
Gait velocity (meters/seconds)
Change in Temporal parameters after 60 days
时间窗: Day 60
Step duration (seconds), gait period (seconds),stance period (seconds), swing period (seconds), double support (seconds)
Change in balance after 60 days - center of pressure velocity
时间窗: Day 60
Balance during Romberg Test. From the center of pressure (COP) the following parameters will be extracted: mean COP velocity (mm/s)
Change in Spatiotemporal parameters after 30 days - Gait velocity
时间窗: Day 30
Gait velocity (meters/seconds)
Change in balance after 60 days - center of pressure frequency
时间窗: 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.
Change in balance after 60 days - center of pressure sway area
时间窗: 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).
Change in Spatial parameters after 60 days
时间窗: Day 60
Step width (meters), step length (meters)
Change in Temporal parameters after 30 days
时间窗: Day 30
Step duration (seconds), gait period (seconds),stance period (seconds), swing period (seconds), double support (seconds)
Change in balance after 60 days - center of pressure spatial parameters
时间窗: 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)
Change in Spatiotemporal parameters after 30 days - Cadence
时间窗: Day 30
Cadence (steps/minute)
Change in Spatiotemporal parameters after 60 days - Cadence
时间窗: Day 60
Cadence (steps/minute)
Change in muscle forces after 60 days
时间窗: Day 60
Musculotendon forces estimated via musculoskeletal modeling (OpenSim, CEINMS)
Change in joint kinematics after 30 days
时间窗: Day 30
Joint kinematics (degrees): trunk, pelvis, hip, knee, ankle (flexion-extension, ab-adduction, internal - external rotation)
Change in Spatial parameters after 30 days
时间窗: Day 30
Step width (meters), step length (meters)
Change in balance after 30 days - center of pressure spatial parameters
时间窗: 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).
Change in balance after 30 days - center of pressure velocity
时间窗: Day 30
Balance during Romberg Test. From the center of pressure (COP) the following parameters will be extracted: mean COP velocity (mm/s)
Change in balance after 30 days - center of pressure ellipse parameters
时间窗: 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).
Change in balance after 30 days - center of pressure frequency
时间窗: 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.
Change in balance after 60 days - center of pressure ellipse parameters
时间窗: 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).
Change in balance after 30 days - center of pressure sway area
时间窗: 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).
Change in muscle forces after 30 days
时间窗: Day 30
Musculotendon forces estimated via musculoskeletal modeling (OpenSim, CEINMS)
次要结局
- Change in Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) after 30 days(Day 30)
- Change in Timed Up and Go test (TUG) after 60 days(Day 60)
- Change in Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) after 60 days(Day 60)
- Change The New Freezing of Gait Questionnaire (N-FOGQ) severity after 60 days(Day 60)
- Change in neurophysiological assessment after 30 days : electromyography (EMG)(Day 30)
- Change in neurophysiological assessment after 30 days : functional Magnetic Resonance Imaging (fMRI)(Day 30)
- Change in Timed Up and Go test (TUG) after 30 days(Day 30)
- Change in Berg Balance Scale (BBS) after 30 days(Day 30)
- Change in Falls Efficacy Scale (FES) after 60 days(Day 60)
- Change in 6 minutes walking test (6-WT) after 60 days(Day 60)
- Change in Ziegler Protocol for the assessment of Freezing of Gait (FOG) severity after 30 days(Day 30)
- Change in Ziegler Protocol for the assessment of Freezing of Gait (FOG) severity after 60 days(Day 60)
- Change in neurophysiological assessment after 60 days : electroencephalogram (EEG)(Day 60)
- Change in Berg Balance Scale (BBS) after 60 days(Day 60)
- Change in Falls Efficacy Scale (FES) after 30 days(Day 30)
- Change in 6 minutes walking test (6-WT) after 30 days(Day 30)
- Change The New Freezing of Gait Questionnaire (N-FOGQ) severity after 30 days(Day 30)
- Change in neurophysiological assessment after 60 days : electromyography (EMG)(Day 60)
- Change in neurophysiological assessment after 30 days : electroencephalogram (EEG)(Day 30)
- Change in neurophysiological assessment after 60 days : functional Magnetic Resonance Imaging (fMRI)(Day 60)
研究者
ZIMI SAWACHA.
Associate Professor
University of Padova