MIRT and Rotigotine in the Early Stage of PD

• Conditions: Parkinson's Disease
• Interventions: Other: Multidisciplinary intensive rehabilitation treatment; Drug: Rotigotine

• Registration Number: NCT02100176
• Lead Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

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).

Study Timeline

• Study Start: 2013-01
• Status Verified: 2014-03
• Primary Completion: 2014-03
• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-03-26
• Last Update Submitted: 2014-03-26
• Study First Posted: 2014-03-31
• Last Update Posted: 2014-03-31
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rotigotine and MIRT	Multidisciplinary intensive rehabilitation treatment	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	Rotigotine	Group 2 - 20 Patients with PD (H\&Y stages 1,5-2)
Rotigotine and MIRT	Rotigotine	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).

Primary Outcome Measures

Name	Time	Method
UPDRS total score	18 Months	Unified Parkinson's Disease Rating Scale total score

Secondary Outcome Measures

Name	Time	Method
UPDRS II	18 Months	Unified Parkinson's disease Rating Scale II
UPDRS III	18 Months	Unified Parkinson's disease Rating Scale
6MWT	18 Months	Six Minutes Walking Test
BBS	18 Months	Berg Balance Scale
TUG	18 Months	Time up and go test
CGS and FGS	18 Months	Comfortable and fast gait speed
SPDDS	18 Months	Self-Assessment Parkinson's Disease Disability Scale

Trial Locations

Locations (2)

Riabilitazione Neuromotoria, Istituto Scientifico di Montescano; 🇮🇹 Montescano, Pavia, Italy

Ospedale Generale di Zona "Moriggia-Pelascini"; 🇮🇹 Gravedona, Como, Italy