MIRT and Rotigotine in the Early Stage of PD (MIRT-RT)

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson's Disease
• Intervention / Treatment: Other: Multidisciplinary intensive rehabilitation treatment; Drug: Rotigotine

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Giuseppe Frazzitta, MD; Phone Number: +39034492552; Email: frazzittag62@gmail.com

Study Locations

• Italy
  • Como
    • Gravedona, Como, Italy, 22015
      • Recruiting
      • Ospedale Generale di Zona "Moriggia-Pelascini"
      • Contact: Giuseppe Ferrazzoli, MD; Phone Number: +39034492552; Email: frazzittag62@gmail.com
  • Pavia
    • Montescano, Pavia, Italy, 27040
      • Recruiting
      • Riabilitazione Neuromotoria, Istituto Scientifico di Montescano
      • Contact: Giuseppe Frazzitta, MD; Phone Number: +39034492552; Email: frazzittag62@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Parkinson's disease "de novo" Patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	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; Other Names: Dopamine agonist drug
Control group, only Rotigotine; Group 2 - 20 Patients with PD (H&Y stages 1,5-2)	Drug: Rotigotine; Rotigotine 2-8 mg/24 h; 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
L Dopa	levo-dopa equivalent dosage	18 Months

Collaborators and Investigators

• Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: March 24, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (Estimate): March 31, 2014

Study Record Updates

• Last Update Posted (Estimate): March 31, 2014
• Last Update Submitted That Met QC Criteria: March 26, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Rehabilitation treatment
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Cardiotonic Agents; Dopamine Agents; Sympathomimetics; Rotigotine; Dopamine; Dopamine Agonists
• Other Study ID Numbers: MIRT-RT (Other Identifier: Ospedale Generale di Zona "Moriggia-Pelascini")