|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT02100176 |
|
Date of registration:
|
24/03/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
MIRT and Rotigotine in the Early Stage of PD
MIRT-RT |
|
Scientific title:
|
Multidisciplinary Intensive Rehabilitation Treatment and Rotigotine in the Early Stages of Parkinson's Disease: a Randomized Controlled Study. |
|
Date of first enrolment:
|
January 2013 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT02100176 |
|
Study type:
|
Observational [Patient Registry] |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Italy
| | | | | | | |
|
Contacts
|
|
Name:
|
Giuseppe Frazzitta, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Ospedale generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti 22015 - CO, Italy |
|
|
Name:
|
Giuseppe Frazzitta, MD |
|
Address:
|
|
|
Telephone:
|
+39034492552 |
|
Email:
|
frazzittag62@gmail.com |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
50 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Parkinson's Disease
|
|
Intervention(s)
|
|
Drug: Rotigotine
|
|
Other: Multidisciplinary intensive rehabilitation treatment
|
|
Primary Outcome(s)
|
|
UPDRS total score
[Time Frame: 18 Months]
|
|
Secondary Outcome(s)
|
|
6MWT
[Time Frame: 18 Months]
|
|
UPDRS II
[Time Frame: 18 Months]
|
|
UPDRS III
[Time Frame: 18 Months]
|
|
BBS
[Time Frame: 18 Months]
|
|
CGS and FGS
[Time Frame: 18 Months]
|
|
SPDDS
[Time Frame: 18 Months]
|
|
TUG
[Time Frame: 18 Months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|