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Clinical Trials/NCT02731170
NCT02731170
Unknown
N/A

Effectiveness of Intensive Rehabilitation in Advanced Stages of Parkinson's Disease.

Ospedale Generale Di Zona Moriggia-Pelascini1 site in 1 country439 target enrollmentJanuary 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Enrollment
439
Locations
1
Primary Endpoint
Unified Parkinson Disease Rating Scale
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
June 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Responsible Party
Principal Investigator
Principal Investigator

Ilaria Zivi

MD

Ospedale Generale Di Zona Moriggia-Pelascini

Eligibility Criteria

Inclusion Criteria

  • clinica diagnosis of Parkinson Disease

Exclusion Criteria

  • comorbidity with other neurological conditions

Outcomes

Primary Outcomes

Unified Parkinson Disease Rating Scale

Time Frame: 4 weeks

six-minutes walking test

Time Frame: 4 weeks

Time up and go Test

Time Frame: 4 weeks

Berg Balance Scale

Time Frame: 4 weeks

Parkinson's Disease Disability Scale

Time Frame: 4 weeks

Freezing of Gait Questionnaire

Time Frame: 4 weeks

Study Sites (1)

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