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.
1 other identifier
observational
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 24, 2014
CompletedFirst Posted
Study publicly available on registry
March 31, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedMarch 31, 2014
March 1, 2014
1.2 years
March 24, 2014
March 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
UPDRS total score
Unified Parkinson's Disease Rating Scale total score
18 Months
Secondary Outcomes (7)
UPDRS II
18 Months
UPDRS III
18 Months
6MWT
18 Months
BBS
18 Months
TUG
18 Months
- +2 more secondary outcomes
Other Outcomes (1)
L Dopa
18 Months
Study Arms (2)
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).
Control group, only Rotigotine
Group 2 - 20 Patients with PD (H\&Y stages 1,5-2)
Interventions
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 2-8 mg/24 h
Eligibility Criteria
Parkinson's disease "de novo" Patients
You may qualify if:
- 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.
You may not qualify if:
- Atypical Parkinsonisms, cognitive impairment (MMSE \< 26), other comorbidities not related to PD, vestibular/visual dysfunction limiting locomotor or balance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Ospedale Generale di Zona "Moriggia-Pelascini"
Gravedona, Como, 22015, Italy
Riabilitazione Neuromotoria, Istituto Scientifico di Montescano
Montescano, Pavia, 27040, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Frazzitta, MD
Ospedale generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti 22015 - CO, Italy
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 18 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2014
First Posted
March 31, 2014
Study Start
January 1, 2013
Primary Completion
March 1, 2014
Study Completion
June 1, 2014
Last Updated
March 31, 2014
Record last verified: 2014-03