ROBOPARKUse of a Robot for the Rehabilitation of Walking in Patients With Parkinson's Disease.
Robot-Assisted Gait Training (RAGT)
+ Treadmill Gait Training (TT)
Synucleinopathies+16
+ Basal Ganglia Diseases
+ Brain Diseases
Treatment Study
Summary
Study start date: March 30, 2012
Actual date on which the first participant was enrolled.The specific aims of this project are: 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; to analyze possible improvements in terms of physiological biomechanical gait through analysis of kinematics , kinetics and EMG evaluation; 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; to evaluate the kinematic, kinetic and EMG quantitative data during selected movements (gait, posture, ) compared with age matched reference data; 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
San Raffaele Cassino
Cassino, ItalyIRCCS San Raffaele Pisana
Rome, Italy