Completed

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

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What is being tested

Robot-Assisted Gait Training (RAGT)

+ Treadmill Gait Training (TT)

DeviceProcedure
Who is being recruted

Synucleinopathies+16

+ Basal Ganglia Diseases

+ Brain Diseases

From 18 to 80 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 2012
See protocol details

Summary

Principal SponsorIRCCS San Raffaele Roma
Last updated: April 10, 2024
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorIRCCS San Raffaele Roma
Last updated: April 10, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

SynucleinopathiesBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesCranial Nerve DiseasesEye DiseasesMovement DisordersNervous System DiseasesNeurologic ManifestationsOphthalmoplegiaParalysisSigns and SymptomsPathological Conditions, Signs and SymptomsOcular Motility DisordersNeurodegenerative DiseasesParkinsonian DisordersTauopathiesParkinson DiseaseSupranuclear Palsy, Progressive

Criteria

5 inclusion criteria required to participate
Able to walk 25 feet unassisted or with minimal assistance

Age between 18-80

Diagnosis of idiopathic PD or PSP by UK Brain Bank criteria

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

Show More Criteria

1 exclusion criteria prevent from participating
Other significant neurological or orthopedic problems

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

Active Comparator
Treadmill Gait Training (TT): Subjects (at least 40) 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.

Study 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

Polytecnic University of Marche

Ancona, ItalyOpen Polytecnic University of Marche in Google Maps

San Raffaele Cassino

Cassino, Italy

IRCCS San Raffaele Pisana

Rome, Italy
Completed3 Study Centers