Robot Walking Rehabilitation in Parkinson’s Disease

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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