Robot Walking Rehabilitation in Parkinson’s Disease

Related Clinical Trial
Unstructured Eye Tracking as a Diagnostic and Prognostic Biomarker in Parkinsonian Disorders Study of Comprehensive ANd Multimodal Marker-based Cohort of Progressive Supranuclear Palsy(PSP) Personalized Parkinson Project PSP Cohort Cholinergic Mechanisms of Attentional-motor Integration and Gait Dysfunction in Parkinson Disease (UDALL) Tau Protein and SV2a Imaging in Patients With Tau Protein-related Diseases Building Online Community for Parkinson’s Palliative Care Test-retest Study With [18F]PI-2620 in PSP-RS and NDC Evaluation of the Efficacy of a Two-week EMST on Dysphagia in Parkinsonian Patients Optimization of Morphomer-based Alpha-synuclein PET Tracers Evaluation of [18F]APN-1607 as a PET Biomarker A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP) RT001 in Patients With Progressive Supranuclear Palsy (PSP) PROGRESSIVE SUPRANUCLEAR PALSY Complex Eye Movements in Parkinson’s Disease and Related Movement Disorders tDCS and Speech Therapy for Motor Speech Disorders Caused by FTLD Syndromes: a Feasibility Study Application od Machine Learning Method in Validation of Screening Cognitive Test for Parkinsonisms Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA) Remote Monitoring in Progressive Supranuclear Palsy (PSP) Trial of Parkinson’s And Zoledronic Acid Rho Kinase (ROCK) Inhibitor in Tauopathies – 1 UPenn Observational Research Repository on Neurodegenerative Disease Evaluation of Imaging Characteristics of [18F]PI-2620 PET in AD and PSP Patients Using High and Low Specific Activity Systematic Assessment of Laryngopharyngeal Function in Patients With MSA, PD, and 4repeat Tauopathies The MOTIVE-PSP Initiative A Study to Test the Safety and Tolerability of Long-term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) in Progressive Supranuclear Palsy (PSP) (STIM-PSP) Image Characteristic and Longitudinal Follow up of 18F-PMPBB3 (APN-1607) PET for Progressive Supranuclear Palsy Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of NIO752 in Progressive Supranuclear Palsy Misfolded Proteins in the Skin of People With Parkinson’s Disease and Other Parkinsonism Neurodegenerative Diseases Registry Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy 18F-PM-PBB3 PET Study in Tauopathy Including Alzheimer’s Disease, Other Dementias and Normal Controls Brain Network Activation in Patients With Movement Disorders Neurologic Stem Cell Treatment Study ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) Transcranial Duplex Scanning and Single Photon Emission Computer Tomography (SPECT) in Parkinsonian Syndromes ADDIA Proof-of-Performance Clinical Study Defining Phenotypes of Movement Disorders :Parkinson’s Plus Disorders (PD), Essential Tremor (ET), Cortical Basal Degeneration (CBD), Multiple Systems Atrophy (MSA), Magnetoencephalography. Gait Analysis in Neurological Disease Diagnosing Frontotemporal Lobar Degeneration Evaluation of [18F]MNI-815 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Tauopathies Study of the Neural Basis of Analogical Reasoning Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Phase 1 Test-retest Evaluation of [18F]MNI-958 PET Diagnostic and Prognostic Biomarkers in Parkinson Disease Tau Imaging With JNJ067 Research of Biomarkers in Parkinson Disease More Than a Movement Disorder: Applying Palliative Care to Parkinson’s Disease Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism Identifying Biomarkers of Parkinson’s Disease Using Magnetic Resonance Imaging (MRI) Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL) Davunetide (AL-108) in Predicted Tauopathies – Pilot Study Robot Walking Rehabilitation in Parkinson’s Disease Human CNS Tau Kinetics in Tauopathies 4-Repeat Tauopathy Neuroimaging Initiative – Cycle 2 In-Home Care for Patients With PSP and Related Disorders Facilitating Diagnostics and Prognostics of Parkinsonian Syndromes Using Neuroimaging Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA) Biomarkers in Parkinsonian Syndromes Evaluation of [18F]MNI-952 as a Potential PET Radioligand for Imaging Tau Protein in the Brain Effects of Coenzyme Q10 in PSP and CBD 2-(1-{6-[(2-[F-18]Fluoroethyl) (Methyl)Amino]-2-naphthyl} Ethylidene) Malononitrile-PET for in Vivo Diagnose of Tauopathy in Unclassified Parkinsonism Oxford Study of Quantification in Parkinsonism A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese Patients Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects The Neural Basis for Frontotemporal Degeneration Analysis of the Enteric Nervous System Using Colonic Biopsies Evaluation of Tolfenamic Acid in Individuals With PSP at 12-Weeks Chromatic Pupillometry to Assess the Melanopsin-Light Pathway in Progressive Supranuclear Palsy 4 Repeat Tauopathy Neuroimaging Initiative A Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 in Patients With PSP Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson’s Disease and Progressive Supranuclear Palsy. Safety Study of TPI-287 to Treat CBS and PSP Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain Neuroprotection and Natural History in Parkinson’s Plus Syndromes (NNIPPS) Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy A 6 Month, Open-Label, Pilot Futility Clinical Trial of Oral Salsalate for Progressive Supranuclear Palsy Pathophysiology of Gait and Posture in Progressive Supranuclear Palsy A Pilot Clinical Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy. Clinical Trial to Evaluate Bone Marrow Stem Cell Therapy for PSP, a Rare Form of Parkinsonism tDCS Plus Physical Therapy for Progressive Supranuclear Palsy Repetitive Transcranial Magnetic Stimulation (TMS) for Progressive Supranuclear Palsy and Corticobasal Degeneration Risk Factors for Progressive Supranuclear Palsy (PSP) Continuously Infused Recombinant-Methionyl Human Glial Cell Line-Derived Neurotrophic Factor (GDNF) to Treat Progressive Supranuclear Palsy Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy Neuropsychological Evaluation for Early Diagnosis of PSP Evaluating Cerebrospinal Fluid Biomarkers in Alzheimer’s, Progressive Supranuclear Palsy Subjects, and Controls A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104 Study About Safety and Efficacy of Coenzyme Q10 in Progressive Supranuclear Palsy Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003 PROgressive Supranuclear Palsy CorTico-Basal Syndrome Multiple System Atrophy Longitudinal Study UK The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy Young Plasma Transfusions for Progressive Supranuclear Palsy Study of BIIB092 in Participants With Progressive Supranuclear Palsy A Study to Test the Safety and Tolerability of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP) Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy Deep TMS for the Treatment of Patients With Parkinson’s Disease and Progressive Supranuclear Palsy Rehabilitation in Patients With Progressive Supranuclear Palsy A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy Alpha-lipoic Acid/L-acetyl Carnitine for Progressive Supranuclear Palsy Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear Palsy Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP) Quality of Life of the Patient and the Burden of the Caregiver in Progressive Supranuclear Palsy An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP) A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP). Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy (Depakine) Safety, Tolerability, and Efficacy of Two Different Oral Doses of NP031112 Versus Placebo in the Treatment of Patients With Mild-to-Moderate Progressive Supranuclear Palsy Efficacy, Tolerability and Safety of Azilect in Subjects With Progressive Supranuclear Palsy Postural Instability in Progressive Supranuclear Palsy

Brief Title

Robot Walking Rehabilitation in Parkinson's Disease

Official Title

Use of a Robot for the Rehabilitation of Walking in Patients With Parkinson's Disease.

Brief Summary

      The effectiveness of non-pharmacological treatment on gait impairment on Parkinson Disease
      (PD) such as exercises has been demonstrated; in particular an example for patient tailored
      exercises is physiotherapy. The goal of physiotherapy treatment is to enable PD patients to
      maintain their maximum level of mobility, activity, and independence. Several systematic
      reviews and clinical studies have shown that physical therapy can contribute to minimize the
      disabling effects of motor and sensory impairments in order to enhance participation in
      societal roles and quality of life. The use of electromechanical devices such as treadmill
      training (a supplement to conventional therapies) in the last years has also been used with
      PD patients and a systematic Cochrane has been conducted by Mehrholz in 2010 to assess the
      effectiveness and acceptability of treadmill training in the treatment of gait disorders for
      patients with PD. In the last years new robotic assisted device can be used in gait training
      in neurological disorder. Till now only few studies, have focused on the effects of
      exoskeleton or end effector robot-assisted training in PD patients, with a interesting
      preliminary results.
    

Detailed Description

      The specific aims of this project are:

        1. to verify whether the robotics lower limb treatment with body weight support is more
           effective than the treadmill treatment in the reduction of motor impairment in PD or PSP
           patients, and to improve the quality of the gait and the endurance;

        2. to analyze possible improvements in terms of physiological biomechanical gait through
           analysis of kinematics , kinetics and EMG evaluation;

        3. to analyze possible improvements in terms of reduction of instable posture and movements
           , which can represent a reduction of the risk of fall typical of these subjects;

        4. to evaluate the kinematic, kinetic and EMG quantitative data during selected movements
           (gait, posture, ) compared with age matched reference data;

        5. to investigate the stability of the effects of robot-assisted treatment at 4/6 months
           follow-up in terms of Quality of Life (QoL).

      A first goal of this project is to investigate the differences in improvement of the quality
      and safety of the gait (motor performance and functional recovery) through kinematic/kinetic
      and EMG parameters (Change in Step Length, Change in Gait Velocity and Change in Stride Time
      Variability, 3D joints kinematics, ground reaction forces, joint kinetics, muscle
      activation,) and traditional clinical scales in Parkinson's patients.

      The second goals is aimed at identifying possible advantages in the QoL of patients
      undergoing such a kind of rehabilitation treatment and at investigating novel methods
      enabling lower limb functional recovery, leading to wide potential for regaining personal
      independence.

      The third goal is to analyze direct cost savings associated with the use of such
      technologies, measured as direct, indirect and intangible costs, through specific HTA
      procedures.
    


Study Type

Interventional


Primary Outcome

6 minutes walking test.

Secondary Outcome

 Time Up and Go test.

Condition

Idiopathic Parkinson's Disease

Intervention

Robot-Assisted Gait Training (RAGT)

Study Arms / Comparison Groups

 Robot-Assisted Gait Training (RAGT)
Description:  Robot-Assisted Gait Training (RAGT): Subjects (at least 40) will undergo inpatient rehabilitation consisting of a treatment cycle using the GE-O system device, according to individually tailored exercise scheduling. The practice will include robot-assisted walking at variable speeds for 45 min with a partial body weight support (BWS). All participants started with 30-40% BWS and an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h before BWS will be decreased.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

80

Start Date

March 30, 2012

Completion Date

March 31, 2016

Primary Completion Date

August 30, 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of idiopathic PD or PSP by UK Brain Bank criteria,

          -  Age between 18-80;

          -  Able to walk 25 feet unassisted or with minimal assistance;

          -  On stable doses of Parkinson's medications for at least 2 weeks prior to study onset;

          -  Endurance sufficient to stand at least 20 minutes unassisted per patient report.

        Exclusion Criteria:

          -  Other significant neurological or orthopedic problems.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Patrizio Sale, MD, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT01668407

Organization ID

545/2012/61/2012


Responsible Party

Principal Investigator

Study Sponsor

IRCCS San Raffaele


Study Sponsor

Patrizio Sale, MD, Principal Investigator, IRCCS San Raffale Pisana


Verification Date

January 2018