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

Ospedale Generale Di Zona Moriggia-Pelascini

Status: Unknown

Conditions: Parkinson Disease

Treatments: Behavioral: MIRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02731170

Rehabilitation and PD

Details and patient eligibility

About

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

Full 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.

Enrollment: 439 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

clinica diagnosis of Parkinson Disease

Exclusion criteria

comorbidity with other neurological conditions

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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439 participants in 1 patient group

rehabilitation treatment (MIRT)

Experimental group

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)

Treatment:

Behavioral: MIRT