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