Clinical trial NCT02731170: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Advanced Stages
Rehabilitation
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 439
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

clinica diagnosis of Parkinson Disease

Exclusion Criteria:

comorbidity with other neurological conditions

Primary outcomes:
measure: Unified Parkinson Disease Rating Scale
timeFrame: 4 weeks
measure: six-minutes walking test
timeFrame: 4 weeks
measure: Time up and go Test
timeFrame: 4 weeks
measure: Berg Balance Scale
timeFrame: 4 weeks
measure: Freezing of Gait Questionnaire
timeFrame: 4 weeks
measure: Parkinson's Disease Disability Scale
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gravedona ed Uniti
country: Italy
facility: Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
state: Como
Study officials:
References: