MIRT and Rotigotine in the Early Stage of PD

Parkinson's Disease Clinical Trial

— MIRT-RT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02100176
• Other study ID #: MIRT-RT
• Secondary ID: MIRT-RT
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2014
• Last updated: March 26, 2014
• Start date: January 2013
• Est. completion date: June 2014

Study information

• Verified date: March 2014
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: Giuseppe Frazzitta, MD
• Phone: +39034492552
• Email: frazzittag62[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• Multidisciplinary intensive rehabilitation treatment
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.

Drug:
• Rotigotine
Rotigotine 2-8 mg/24 h

Locations

Country	Name	City	State
Italy	Ospedale Generale di Zona "Moriggia-Pelascini"	Gravedona	Como
Italy	Riabilitazione Neuromotoria, Istituto Scientifico di Montescano	Montescano	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	L Dopa	levo-dopa equivalent dosage	18 Months	Yes
Primary	UPDRS total score	Unified Parkinson's Disease Rating Scale total score	18 Months	Yes
Secondary	UPDRS II	Unified Parkinson's disease Rating Scale II	18 Months	Yes
Secondary	UPDRS III	Unified Parkinson's disease Rating Scale	18 Months	Yes
Secondary	6MWT	Six Minutes Walking Test	18 Months	Yes
Secondary	BBS	Berg Balance Scale	18 Months	Yes
Secondary	TUG	Time up and go test	18 Months	Yes
Secondary	CGS and FGS	Comfortable and fast gait speed	18 Months	Yes
Secondary	SPDDS	Self-Assessment Parkinson's Disease Disability Scale	18 Months	Yes