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| ID | Type | Description | Link |
|---|---|---|---|
| MIRT-RT | Other Identifier | Ospedale Generale di Zona "Moriggia-Pelascini" |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
| |
| Control group, only Rotigotine | Group 2 - 20 Patients with PD (H&Y stages 1,5-2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidisciplinary intensive rehabilitation treatment | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| UPDRS total score | Unified Parkinson's Disease Rating Scale total score | 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| UPDRS II | Unified Parkinson's disease Rating Scale II | 18 Months |
| UPDRS III | Unified Parkinson's disease Rating Scale | 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| L Dopa | levo-dopa equivalent dosage | 18 Months |
Inclusion Criteria:
Exclusion Criteria:
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Parkinson's disease "de novo" Patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giuseppe Frazzitta, MD | Contact | +39034492552 | frazzittag62@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe Frazzitta, MD | Ospedale generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti 22015 - CO, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Generale di Zona "Moriggia-Pelascini" | Recruiting | Gravedona | Como | 22015 | Italy |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C047508 | rotigotine |
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| Rotigotine | Drug | Rotigotine 2-8 mg/24 h |
|
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| 6MWT | Six Minutes Walking Test | 18 Months |
| BBS | Berg Balance Scale | 18 Months |
| TUG | Time up and go test | 18 Months |
| CGS and FGS | Comfortable and fast gait speed | 18 Months |
| SPDDS | Self-Assessment Parkinson's Disease Disability Scale | 18 Months |
| Riabilitazione Neuromotoria, Istituto Scientifico di Montescano | Recruiting | Montescano | Pavia | 27040 | Italy |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |