Idiopathic Parkinson's DiseaseROBOPARKNCT01668407
Robot Walking Rehabilitation in Parkinson's Disease
A study testing Robot-Assisted Gait Training (RAGT) and Treadmill Gait Training (TT) in people with Idiopathic Parkinson's Disease and Progressive Supranuclear Palsy, run by IRCCS San Raffaele Roma at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Idiopathic Parkinson's Disease, Progressive Supranuclear Palsy
- What is being tested?
- Robot-Assisted Gait Training (RAGT) and Treadmill Gait Training (TT)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesItaly
- Study dates
- 30 Mar 2012to 31 Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Other significant neurological or orthopedic problems.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Polytecnic University of Marche
Ancona
San Raffaele Cassino
Cassino, 03043
IRCCS San Raffaele Pisana
Rome, 00163
About this study
Official title: Use of a Robot for the Rehabilitation of Walking in Patients With Parkinson's Disease.
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.
Read the 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.
- Being tested
- Robot-Assisted Gait Training (RAGT), Treadmill Gait Training (TT)
- Keywords
- Parkinson's disease, PSP, Robot, Gait rehabilitation
- Medical subject headings
- Parkinson Disease, Supranuclear Palsy, Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted Gait Training (RAGT)Device
Also called End effector G-EO System
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.
Treadmill Gait Training (TT)Procedure or surgery
Also called TREADMILL
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.
| Study group | Role | What they receive |
|---|---|---|
| Robot-Assisted Gait Training (RAGT) | 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. Receives: Device: Robot-Assisted Gait Training (RAGT) |
| Treadmill Gait Training (TT) | 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. Receives: Procedure: Treadmill Gait Training (TT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walking test.
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).
Measured: Change from Baseline in gait speed at 6 months follow up.
Secondary outcomes (2)
Time Up and Go test.
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).
Measured: baseline, weekly during intervention, 6 months follow up.
Gait Parameters
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).
Measured: baseline, weekly during intervention, 6 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study start30 Mar 2012
- Primary completion30 Aug 2015
- Study completion31 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrizio Sale, MD, Principal investigator, IRCCS San Raffale Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668407
- Sponsor's protocol ID
- RP 04/12
- Acronym
- ROBOPARK
- Status last verified
- Apr 2024
- First submitted
- 8 May 2012
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24860459Sale 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.
PubMed 23706025
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Robot for the Rehabilitation of Walking in Patients With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT01668407
- Acronym / sponsor ID
- ROBOPARK / RP 04/12
- Keywords
- Parkinson's disease, PSP, Robot, Gait rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 30 Mar 2012 (actual)
- Primary completion
- 30 Aug 2015 (actual)
- Study completion
- 31 Mar 2016 (actual)
- First posted
- 20 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot-Assisted Gait Training (RAGT) | Experimental | Device: 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. |
| Treadmill Gait Training (TT) | Active comparator | Procedure: 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Other significant neurological or orthopedic problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-Assisted Gait Training (RAGT)Also: End effector G-EO SystemSubjects (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 Gait Training (RAGT) |
| Treadmill Gait Training (TT)Also: TREADMILLSubjects (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. | Procedure or surgery | Treadmill Gait Training (TT) |
Primary outcome
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).
2 secondary outcomes
Time Up and Go test.
Time frame: baseline, weekly during intervention, 6 months follow up.
Gait Parameters
Time frame: baseline, weekly during intervention, 6 months follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 24860459Sale 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.
- Derived from this study: PubMed 23706025Sale 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrizio Sale, MD principal investigator
IRCCS San Raffale Pisana
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Assisted Gait Training (RAGT) and Treadmill Gait Training (TT) in people with Idiopathic Parkinson's Disease and Progressive Supranuclear Palsy, run by IRCCS San Raffaele Roma at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minutes walking test. (time frame: Change from Baseline in gait speed at 6 months follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01668407, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.