Robot Walking Rehabilitation in Parkinson's Disease (Robopark)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by IRCCS San Raffaele.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Patrizio Sale , MD, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT01668407
First received: May 8, 2012
Last updated: August 17, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Idiopathic Parkinson's Disease
Progressive Supranuclear Palsy
Device: Robot-assisted walking (G-EO-System End Effector lower limb Robot)
Procedure: Inpatient rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Use of a Robot for the Rehabilitation of Walking in Patients With Parkinson's Disease.

Resource links provided by NLM:


Further study details as provided by IRCCS San Raffaele:

Primary Outcome Measures:
  • 6 minuts walking test. [ Time Frame: Change from Baseline in gait speed at 6 months follow up. ] [ Designated as safety issue: No ]
    The 6 minuts walking test as primary outcome assessments will be collected 1 hour after oral assumption of levodopa at baseline (inclusion)(T0) and endpoint (after 20 robot sesion) (T1) (no later than 1 day > last training session) at the follow-up examination after 6 months from the treatments conclusion (T2).


Secondary Outcome Measures:
  • Time Up and Go test. [ Time Frame: baseline, weekly during intervention, 6 months follow up. ] [ Designated as safety issue: No ]
    Time Up and Go test will be collected 1 hour after oral assumption of levodopa at baseline (inclusion)(T0) and endpoint (after 20 robot sesion) (T1) (no later than 1 day > last training session) at the follow-up examination after 6 months from the treatments conclusion (T2).

  • Gait Parameters [ Time Frame: baseline, weekly during intervention, 6 months follow up. ] [ Designated as safety issue: No ]
    Gait Analysis will be collected 1 hour after oral assumption of levodopa at baseline (inclusion)(T0) and endpoint (after 20 robot sesion) (T1) (no later than 1 day > last training session) at the follow-up examination after 6 months from the treatments conclusion (T2).


Estimated Enrollment: 80
Study Start Date: February 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A - Robot-assisted walking
Group A (GA) of subjects (at least 40 subjects) 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.
Device: Robot-assisted walking (G-EO-System End Effector lower limb Robot)
A group A (GA) of subjects (at least 40 subjects) 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.
Other Name: G-EO-System End Effector lower limb Robot
Active Comparator: Group B - Inpatient rehabilitation
Group B (CG) of subjects (at least 40 subjects) will undergo inpatient rehabilitation consisting of a treatment cycle using the treadmill device, according to individually tailored exercise scheduling. The practice included treadmill walking at variable speed for 45 minutes. All participants will start at an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h.
Procedure: Inpatient rehabilitation

A group B (CG) of subjects (at least 40 subjects) will undergo inpatient rehabilitation consisting of a treatment cycle using the treadmill device, according to individually tailored exercise scheduling. The practice included treadmill walking at variable speed for 45 minutes. All participants will start at an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h.

All the treatment consists of 20 sessions for the lower limbs, each lasting 45 minutes, 5 days a week for 4 weeks.

Other Name: TREADMILL

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668407

Locations
Italy
San Raffaele Cassino Not yet recruiting
Cassino, Italy, 03043
Contact: Maria Francesca De Pandis, MD    0652251    maria.depandis@sanraffaele.it   
IRCCS San Raffaele Pisana Recruiting
Rome, Italy, 00163
Contact: Patrizio Sale, MD, PhD    +390652253402    patrizio.sale@sanraffaele.it   
Contact: Marco Franceschini, MD    +390652253402    marco.franceschini@sanraffaele.it   
Principal Investigator: Patrizio Sale, MD, PhD         
Sub-Investigator: Fabrizio Stocchi, MD         
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Principal Investigator: Patrizio Sale, MD IRCCS San Raffale Pisana
  More Information

No publications provided by IRCCS San Raffaele

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patrizio Sale , MD, MD, PhD, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT01668407     History of Changes
Other Study ID Numbers: 545/2012/61/2012
Study First Received: May 8, 2012
Last Updated: August 17, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by IRCCS San Raffaele:
Parkinson's disease
PSP
Robot
Gait rehabilitation

Additional relevant MeSH terms:
Supranuclear Palsy, Progressive
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Neurologic Manifestations
Ocular Motility Disorders
Ophthalmoplegia
Paralysis
Parkinsonian Disorders
Signs and Symptoms
Tauopathies

ClinicalTrials.gov processed this record on October 22, 2014