Parkinson's DiseaseMIRT-RTNCT02100176
MIRT and Rotigotine in the Early Stage of PD
An observational study of Parkinson's Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 2 sites in Italy.
Trial summary
To test whether a multidisciplinary intensive rehabilitation treatment (MIRT) slowed down the progression of the disease in Parkinson's disease (PD) "de novo" patients, all treated with Rotigotine, in a randomized controlled study with a 18 months follow-up. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Multidisciplinary intensive rehabilitation treatment and Rotigotine
- How many people
- 40 participants
- Where
- 2 sitesItaly
- Study dates
- Jan 2013to Jun 2014
- How long will I take part?
- 18 Months
- Phase
- Observational
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's disease "de novo" Patients
Who may be able to join
- Idiopathic Parkinson's disease according to Gelb et al., ability to walk without any physical assistance, no cognitive impairment (MMSE score > 26), no comorbidity unrelated to Parkinson's disease, no vestibular/visual dysfunction limiting locomotor or balance.
Who cannot join
- Atypical Parkinsonisms, cognitive impairment (MMSE < 26), other comorbidities not related to PD, vestibular/visual dysfunction limiting locomotor or balance.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Ospedale Generale di Zona "Moriggia-Pelascini"
Gravedona, Como, 22015
Giuseppe Ferrazzoli, MD, +39034492552, frazzittag62@gmail.com
- Recruiting
Riabilitazione Neuromotoria, Istituto Scientifico di Montescano
Montescano, Pavia, 27040
Giuseppe Frazzitta, MD, +39034492552, frazzittag62@gmail.com
About this study
Official title: Multidisciplinary Intensive Rehabilitation Treatment and Rotigotine in the Early Stages of Parkinson's Disease: a Randomized Controlled Study.
To test whether a multidisciplinary intensive rehabilitation treatment (MIRT) slowed down the progression of the disease in Parkinson's disease (PD) "de novo" patients, all treated with Rotigotine, in a randomized controlled study with a 18 months follow-up.
Read the detailed description
In the last years different rehabilitation treatments have been proposed to address specific motor deficits in Parkinson's disease. Nevertheless, the evidence of a possible neuroprotective action of exercise in PD has been obscured by the facts that all studies were performed in patients in different disease stages and under a variety of pharmacological treatments. Our objective is to test whether a multidisciplinary intensive rehabilitation treatment (MIRT) slowed down the progression of the disease in PD "de novo" patients, all treated with Rotigotine, in a randomized controlled study with a 18 months follow-up.
40 Patients at the initial stages of PD (H\&Y stages 1,5-2) treated only with Rotigotine will be enrolled and randomly assigne into two groups. Patients in group 1 (20 subjects) will be undergone 2 MIRT cycle (at T0 and T3). MIRT consist of a 4-week cycle of physiotherapy that entailed three daily sessions 5 days a week (Frazzitta G. et al., Neurorehabilitation [30] 2012, 295-301). Patients in Group 2 (20 subjects) will continue with drug therapy alone.
For the group 1, Unified Parkinson's disease rating scale (UPDRS) II, UPDRS III, six-minute walking test (6MWT), Berg Balance Scale (BBS), Timed-up-and-go test (TUG), comfortable and fast gait speed, Self-assessment Parkinson's disease disability scale and L-dopa equivalents will be assessed at Baseline T0, T1 (discharge after the first MIRT cycle), T2 (control at 6 months after discharge), T3 (hospitalization for second MIRT cycle), T4 (discharge after the second MIRT cycle) and T5 (end of the protocol, 18 months); For the group 2, UPDRS II, UPDRS III, six-minute walking test (6MWT), Berg Balance Scale (BBS), Timed-up-and-go test (TUG), confortable and fast gait speed, Self-assessment Parkinson's disease disability scale and L-dopa equivalents will be assessed at Baseline T0, T1 (check-up at 6 months), T2 (check-up at 12 months), T3 (check-up at 18 months).
- Conditions
- Parkinson's Disease
- Being tested
- Multidisciplinary intensive rehabilitation treatment, Rotigotine
- Keywords
- Rehabilitation treatment
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary intensive rehabilitation treatmentOther
The first session comprises cardiovascular warm-up activities, relaxation exercises, muscle-stretching exercises, exercises to improve the range of motion of spinal, pelvic and scapular joints, exercises to improve the functionality of the abdominal muscles, and postural changes in supine position. The second session comprises exercises to improve balance and gait using a stabilometric platform with a visual cue and treadmill plus. The last session is a session of occupational therapy aimed to improve autonomy in daily living activities.
RotigotineDrug
Also called Dopamine agonist drug
Rotigotine 2-8 mg/24 h
| Study group | Role | What they receive |
|---|---|---|
| Rotigotine and MIRT | Group 1 - 20 Patients with PD (H\&Y stages 1,5-2) in therapy only with Rotigotine will undergo a Multidisciplinary intensive rehabilitation treatment (MIRT). Receives: Other: Multidisciplinary intensive rehabilitation treatment; Drug: Rotigotine | |
| Control group, only Rotigotine | Group 2 - 20 Patients with PD (H\&Y stages 1,5-2) Receives: Drug: Rotigotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS total score
Unified Parkinson's Disease Rating Scale total score
Measured: 18 Months
Secondary outcomes (7)
UPDRS II
Unified Parkinson's disease Rating Scale II
Measured: 18 Months
UPDRS III
Unified Parkinson's disease Rating Scale
Measured: 18 Months
6MWT
Six Minutes Walking Test
Measured: 18 Months
BBS
Berg Balance Scale
Measured: 18 Months
TUG
Time up and go test
Measured: 18 Months
CGS and FGS
Comfortable and fast gait speed
Measured: 18 Months
SPDDS
Self-Assessment Parkinson's Disease Disability Scale
Measured: 18 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startJan 2013
- Primary completionMar 2014
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Frazzitta, MD, Principal investigator, Ospedale generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti 22015 - CO, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100176
- Sponsor's protocol ID
- MIRT-RT
- Other IDs
- MIRT-RT
- Acronym
- MIRT-RT
- Status last verified
- Mar 2014
- First submitted
- 24 Mar 2014
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Intensive Rehabilitation Treatment and Rotigotine in the Early Stages of Parkinson's Disease: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT02100176
- Acronym / sponsor ID
- MIRT-RT / MIRT-RT
- Conditions
- Parkinson's Disease
- Keywords
- Rehabilitation treatment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2014 (estimated)
- First posted
- 31 Mar 2014 (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.
To test whether a multidisciplinary intensive rehabilitation treatment (MIRT) slowed down the progression of the disease in Parkinson's disease (PD) "de novo" patients, all treated with Rotigotine, in a randomized controlled study with a 18 months follow-up.
Detailed description
In the last years different rehabilitation treatments have been proposed to address specific motor deficits in Parkinson's disease. Nevertheless, the evidence of a possible neuroprotective action of exercise in PD has been obscured by the facts that all studies were performed in patients in different disease stages and under a variety of pharmacological treatments. Our objective is to test whether a multidisciplinary intensive rehabilitation treatment (MIRT) slowed down the progression of the disease in PD "de novo" patients, all treated with Rotigotine, in a randomized controlled study with a 18 months follow-up.
40 Patients at the initial stages of PD (H\&Y stages 1,5-2) treated only with Rotigotine will be enrolled and randomly assigne into two groups. Patients in group 1 (20 subjects) will be undergone 2 MIRT cycle (at T0 and T3). MIRT consist of a 4-week cycle of physiotherapy that entailed three daily sessions 5 days a week (Frazzitta G. et al., Neurorehabilitation [30] 2012, 295-301). Patients in Group 2 (20 subjects) will continue with drug therapy alone.
For the group 1, Unified Parkinson's disease rating scale (UPDRS) II, UPDRS III, six-minute walking test (6MWT), Berg Balance Scale (BBS), Timed-up-and-go test (TUG), comfortable and fast gait speed, Self-assessment Parkinson's disease disability scale and L-dopa equivalents will be assessed at Baseline T0, T1 (discharge after the first MIRT cycle), T2 (control at 6 months after discharge), T3 (hospitalization for second MIRT cycle), T4 (discharge after the second MIRT cycle) and T5 (end of the protocol, 18 months); For the group 2, UPDRS II, UPDRS III, six-minute walking test (6MWT), Berg Balance Scale (BBS), Timed-up-and-go test (TUG), confortable and fast gait speed, Self-assessment Parkinson's disease disability scale and L-dopa equivalents will be assessed at Baseline T0, T1 (check-up at 6 months), T2 (check-up at 12 months), T3 (check-up at 18 months).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotigotine and MIRT | – | Other: Multidisciplinary intensive rehabilitation treatment, Drug: RotigotineGroup 1 - 20 Patients with PD (H\&Y stages 1,5-2) in therapy only with Rotigotine will undergo a Multidisciplinary intensive rehabilitation treatment (MIRT). |
| Control group, only Rotigotine | – | Drug: RotigotineGroup 2 - 20 Patients with PD (H\&Y stages 1,5-2) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease "de novo" Patients
Key inclusion criteria (1 listed)
- Idiopathic Parkinson's disease according to Gelb et al., ability to walk without any physical assistance, no cognitive impairment (MMSE score > 26), no comorbidity unrelated to Parkinson's disease, no vestibular/visual dysfunction limiting locomotor or balance.
Key exclusion criteria (1 listed)
- Atypical Parkinsonisms, cognitive impairment (MMSE < 26), other comorbidities not related to PD, vestibular/visual dysfunction limiting locomotor or balance.
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 |
|---|---|---|
| Multidisciplinary intensive rehabilitation treatmentThe first session comprises cardiovascular warm-up activities, relaxation exercises, muscle-stretching exercises, exercises to improve the range of motion of spinal, pelvic and scapular joints, exercises to improve the functionality of the abdominal muscles, and postural changes in supine position. The second session comprises exercises to improve balance and gait using a stabilometric platform with a visual cue and treadmill plus. The last session is a session of occupational therapy aimed to improve autonomy in daily living activities. | Other | Rotigotine and MIRT |
| RotigotineAlso: Dopamine agonist drugRotigotine 2-8 mg/24 h | Drug | Control group, only Rotigotine, Rotigotine and MIRT |
Primary outcome
UPDRS total score
Time frame: 18 Months
Unified Parkinson's Disease Rating Scale total score
7 secondary outcomes
UPDRS II
Time frame: 18 Months
UPDRS III
Time frame: 18 Months
6MWT
Time frame: 18 Months
BBS
Time frame: 18 Months
TUG
Time frame: 18 Months
CGS and FGS
Time frame: 18 Months
SPDDS
Time frame: 18 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2014.
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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.
Giuseppe Frazzitta, MD principal investigator
Ospedale generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti 22015 - CO, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 2 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 1 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: status not confirmed, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Frazzitta, MD (+39034492552, frazzittag62@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPDRS total score (time frame: 18 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2014.