Effectiveness of Intensive Rehabilitation in Advanced Stages of Parkinson's Disease.
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
MIRT
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Advanced Stages, Rehabilitation
Eligibility Criteria
Inclusion Criteria:
clinica diagnosis of Parkinson Disease
Exclusion Criteria:
comorbidity with other neurological conditions
Sites / Locations
- Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rehabilitation treatment (MIRT)
Arm Description
MIRT consists of a 4-week physical therapy. daily sessions are subdivided in: motor treatment (2 hour), occupational therapy (1 hour) and speech Therapy (1 hour)
Outcomes
Primary Outcome Measures
Unified Parkinson Disease Rating Scale
six-minutes walking test
Time up and go Test
Berg Balance Scale
Freezing of Gait Questionnaire
Parkinson's Disease Disability Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT02731170
First Posted
April 2, 2016
Last Updated
April 3, 2017
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
1. Study Identification
Unique Protocol Identification Number
NCT02731170
Brief Title
Effectiveness of Intensive Rehabilitation in Advanced Stages of Parkinson's Disease.
Official Title
Effectiveness of Intensive Rehabilitation in Advanced Stages of Parkinson's Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
this study is aimed to evaluate the effectiveness of an Multidisciplinary Intensive Rehabilitation Treatment in Advanced Stages of Parkinson's Disease.
In the last years, several evidences highlighted the need of a multidisciplinary and intensive approach to achieve good results in early stage of disease.
Hypothesis is that this approach is effectiveness also in moderate and advanced stages of disease
Detailed Description
Parkinson's Disease (PD) is a progressive neurodegenerative disease clinically characterized by motor and non-motor symptoms.
Dopamine replacement therapy (DRT) is the standard treatment for the motor symptom of PD, however DRT does not reduce axial PD symptoms such as freezing of gait, postural instability and balance disturbances. Further, long-term DRT could negatively impact on cognitive and motivational functions and leads to different motor and behavioural side effects. Therefore, the pharmacological approach becomes less effective in the moderate and advanced stages of disease.
The investigators testing the hypothesis that this approach is effectiveness also in moderate and advanced stages of disease In according with Hoehn and Yahr scale (H&Y) we identified 353 parkinsonian patients on stage 3, 79 subjects on stage 4 and 7 subjects on stage 5.
Clinical scores were assessed at baseline and after 4 weeks by neurologists and physiotherapists expert in movement disorders. All evaluations were performed in the morning, one hour after taking drugs. The assessment included: Unified Parkinson's Disease Rating Scale (UPDRS), for clinical evaluation, Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Six Minutes Walking Test (6MWT), Freezing of Gait Questionnaire (FOGQ) and Abnormal Involuntary Movements Scale (AIMS) for motor symptoms evaluation and, finally, Parkinson's Disease Disability Scale (PDDS), for evaluation of the functional impact of the disease. Since in the advanced stages of PD one of the most troublesome complication includes cognitive disorders, a Neuropsychologist performed a cognitive assessment at the admission. The neuropsychological profile was explored using the Mini Mental State Examination (MMSE), a tool for screening of cognitive impairment, and the Frontal Assessment Battery (FAB) for the evaluation of frontal lobe dysfunctions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Advanced Stages, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
439 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rehabilitation treatment (MIRT)
Arm Type
Experimental
Arm Description
MIRT consists of a 4-week physical therapy. daily sessions are subdivided in: motor treatment (2 hour), occupational therapy (1 hour) and speech Therapy (1 hour)
Intervention Type
Behavioral
Intervention Name(s)
MIRT
Intervention Description
MIRT consists of a 4-week physical therapy, in a hospital setting, which entails four daily sessions for five days and one hour of physical exercise on the sixth day. The duration of each session is about one hour. The first session consists of a one-to-one session with physical therapist involving muscle stretching. The second session includes aerobic exercises to improve balance and gait using different devices: a stabilometric platform, treadmill plus, crossover and cycloergometer. The third is a session of occupational therapy to improve autonomy in everyday activities. The last session includes one hour of speech therapy
Primary Outcome Measure Information:
Title
Unified Parkinson Disease Rating Scale
Time Frame
4 weeks
Title
six-minutes walking test
Time Frame
4 weeks
Title
Time up and go Test
Time Frame
4 weeks
Title
Berg Balance Scale
Time Frame
4 weeks
Title
Freezing of Gait Questionnaire
Time Frame
4 weeks
Title
Parkinson's Disease Disability Scale
Time Frame
4 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinica diagnosis of Parkinson Disease
Exclusion Criteria:
comorbidity with other neurological conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Frazzitta
Phone
+393442719916
Email
ortellipaola73@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Ortelli
Phone
+39 0344 92706
Email
frazzitta62@gmail.com
Facility Information:
Facility Name
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
City
Gravedona ed Uniti
State/Province
Como
ZIP/Postal Code
22015
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Frazzitta, MD
Phone
+39034492564
Email
frazzittag62@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Intensive Rehabilitation in Advanced Stages of Parkinson's Disease.
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