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MIRT and Rotigotine in the Early Stage of PD

NCT ID: NCT02100176

Last Updated: 2014-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Parkinson's Disease

Keywords

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Rehabilitation treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Multidisciplinary intensive rehabilitation treatment

Intervention Type 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.

Rotigotine

Intervention Type DRUG

Rotigotine 2-8 mg/24 h

Control group, only Rotigotine

Group 2 - 20 Patients with PD (H\&Y stages 1,5-2)

Rotigotine

Intervention Type DRUG

Rotigotine 2-8 mg/24 h

Interventions

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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.

Intervention Type OTHER

Rotigotine

Rotigotine 2-8 mg/24 h

Intervention Type DRUG

Other Intervention Names

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Dopamine agonist drug

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Generale Di Zona Moriggia-Pelascini

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giuseppe Frazzitta, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti 22015 - CO, Italy

Locations

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Ospedale Generale di Zona "Moriggia-Pelascini"

Gravedona, Como, Italy

Site Status RECRUITING

Riabilitazione Neuromotoria, Istituto Scientifico di Montescano

Montescano, Pavia, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giuseppe Frazzitta, MD

Role: CONTACT

Phone: +39034492552

Email: [email protected]

Facility Contacts

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Giuseppe Ferrazzoli, MD

Role: primary

Giuseppe Frazzitta, MD

Role: primary

Other Identifiers

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MIRT-RT

Identifier Type: OTHER

Identifier Source: secondary_id

MIRT-RT

Identifier Type: -

Identifier Source: org_study_id