MIRT and Rotigotine in the Early Stage of PD

Study Overview
=================
Brief 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.

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).

Official Title
-----------------
Multidisciplinary Intensive Rehabilitation Treatment and Rotigotine in the Early Stages of Parkinson's Disease: a Randomized Controlled Study.

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: Multidisciplinary intensive rehabilitation treatment
* Drug: Rotigotine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: Atypical Parkinsonisms, cognitive impairment (MMSE < 26), other comorbidities not related to PD, vestibular/visual dysfunction limiting locomotor or balance.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rotigotine and MIRT<br>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). | Other: Multidisciplinary intensive rehabilitation treatment<br>* 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.<br>Drug: Rotigotine<br>* Rotigotine 2-8 mg/24 h<br>* Other names: Dopamine agonist drug;|
| Control group, only Rotigotine<br>Group 2 - 20 Patients with PD (H&Y stages 1,5-2) | Drug: Rotigotine<br>* Rotigotine 2-8 mg/24 h<br>* Other names: Dopamine agonist drug;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| UPDRS total score | Unified Parkinson's Disease Rating Scale total score | 18 Months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation treatment