- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01668407
Robot Walking Rehabilitation in Parkinson's Disease (ROBOPARK)
Use of a Robot for the Rehabilitation of Walking in Patients With Parkinson's Disease.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ancona, Italy
- Polytecnic University of Marche
-
Cassino, Italy, 03043
- San Raffaele Cassino
-
Rome, Italy, 00163
- IRCCS San Raffaele Pisana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Robot-Assisted Gait Training (RAGT)
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.
|
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 Names:
|
Active Comparator: Treadmill Gait Training (TT)
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
6 minutes walking test.
Time Frame: Change from Baseline in gait speed at 6 months follow up.
|
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 session) (T1) (no later than 1 day > last training session) at the follow-up examination after 6 months from the treatments conclusion (T2).
|
Change from Baseline in gait speed at 6 months follow up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time Up and Go test.
Time Frame: baseline, weekly during intervention, 6 months follow up.
|
Time Up and Go test will be collected 1 hour after oral assumption of levodopa at baseline (inclusion)(T0) and endpoint (after 20 robot session) (T1) (no later than 1 day > last training session) at the follow-up examination after 6 months from the treatments conclusion (T2).
|
baseline, weekly during intervention, 6 months follow up.
|
Gait Parameters
Time Frame: baseline, weekly during intervention, 6 months follow up.
|
Gait Analysis will be collected 1 hour after oral assumption of levodopa at baseline (inclusion)(T0) and endpoint (after 20 robot session) (T1) (no later than 1 day > last training session) at the follow-up examination after 6 months from the treatments conclusion (T2).
|
baseline, weekly during intervention, 6 months follow up.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrizio Sale, MD, IRCCS San Raffale Pisana
Publications and helpful links
General Publications
- Sale P, Stocchi F, Galafate D, De Pandis MF, Le Pera D, Sova I, Galli M, Foti C, Franceschini M. Effects of robot assisted gait training in progressive supranuclear palsy (PSP): a preliminary report. Front Hum Neurosci. 2014 Apr 17;8:207. doi: 10.3389/fnhum.2014.00207. eCollection 2014.
- Sale P, De Pandis MF, Le Pera D, Sova I, Cimolin V, Ancillao A, Albertini G, Galli M, Stocchi F, Franceschini M. Robot-assisted walking training for individuals with Parkinson's disease: a pilot randomized controlled trial. BMC Neurol. 2013 May 24;13:50. doi: 10.1186/1471-2377-13-50.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Tauopathies
- Cranial Nerve Diseases
- Ocular Motility Disorders
- Paralysis
- Ophthalmoplegia
- Parkinson Disease
- Supranuclear Palsy, Progressive
Other Study ID Numbers
- RP 04/12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Progressive Supranuclear Palsy
-
Novartis PharmaceuticalsActive, not recruitingProgressive Supranuclear Palsy (PSP)Germany, United Kingdom, Canada, United States
-
AbbVieTerminatedProgressive Supranuclear Palsy (PSP)United States, Australia, Canada, Italy, Japan
-
AbbVieCompletedProgressive Supranuclear Palsy (PSP)United States
-
Assistance Publique Hopitaux De MarseilleCompletedProgressive Supranuclear Palsy (PSP)France
-
Oregon Health and Science UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingSupranuclear Palsy, Progressive | Palsy SupranuclearUnited States
-
University of California, San FranciscoNational Institutes of Health (NIH); National Institute on Aging (NIA)Active, not recruitingProgressive Supranuclear Palsy (PSP) | Corticobasal Degeneration (CBD) | Nonfluent Variant Primary Progressive Aphasia (nfvPPA) | Corticobasal Syndrome (CBS) | Cortical-basal Ganglionic Degeneration (CBGD) | Oligosymptomatic/Variant Progressive Supranuclear Palsy (o/vPSP)United States, Canada
-
University of California, San FranciscoTau Consortium; CBD SolutionsCompletedProgressive Supranuclear Palsy (PSP) | Corticobasal Degeneration (CBD) | Corticobasal Syndrome (CBS) | Primary Four Repeat Tauopathies (4RT)United States
-
UCB Biopharma SRLCompletedProgressive Supranuclear PalsyBelgium, Germany, Spain, United Kingdom
-
Centre Hospitalier Universitaire de Pointe-a-PitreGroupe Hospitalier Pitie-Salpetriere; University Hospital Center of MartiniqueCompletedProgressive Supranuclear Palsy
-
University of LouisvilleCompletedProgressive Supranuclear PalsyUnited States
Clinical Trials on Robot-Assisted Gait Training (RAGT)
-
IRCCS San Raffaele RomaFondazione Don Carlo Gnocchi OnlusCompletedCardiovascular Diseases | Brain Diseases | Central Nervous System Diseases | Gait, Hemiplegic | Acute Stroke | Cerebrovascular Disease | Severe Stroke | Mild StrokeItaly
-
Hadassah Medical OrganizationCompleted
-
Yonsei UniversityRecruitingAcute Hemiplegic Stroke Including Subacute PhasesKorea, Republic of
-
IRCCS Eugenio MedeaCompletedCerebral Palsy | Acquired Brain InjuryItaly
-
Hangang Sacred Heart HospitalMinistry of Health, Republic of KoreaCompletedBurns | Gait Disorder, SensorimotorKorea, Republic of
-
National Rehabilitation Center, Seoul, KoreaCompletedStrokeKorea, Republic of
-
Hangang Sacred Heart HospitalNot yet recruitingBurns | Spinal Cord Injuries | Gait Disorder, Sensorimotor
-
Erenköy Physical Therapy and Rehabilitation HospitalUnknownSpinal Cord InjuriesTurkey
-
Seoul National University HospitalCompletedParkinson Disease | Gait Disorders, NeurologicKorea, Republic of
-
Spaulding Rehabilitation HospitalCompletedCerebral PalsyUnited States