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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02731170
Enrollment
439
Registered
2016-04-07
Start date
2014-01-31
Completion date
2017-06-30
Last updated
2017-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson Disease, Advanced Stages, Rehabilitation

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.

Interventions

BEHAVIORALMIRT

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

Sponsors

Ospedale Generale Di Zona Moriggia-Pelascini
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

clinica diagnosis of Parkinson Disease

Exclusion criteria

comorbidity with other neurological conditions

Design outcomes

Primary

MeasureTime frame
Unified Parkinson Disease Rating Scale4 weeks
six-minutes walking test4 weeks
Time up and go Test4 weeks
Berg Balance Scale4 weeks
Freezing of Gait Questionnaire4 weeks
Parkinson's Disease Disability Scale4 weeks

Countries

Italy

Contacts

Primary ContactGiuseppe Frazzitta
ortellipaola73@gmail.com+393442719916
Backup ContactPaola Ortelli
frazzitta62@gmail.com+39 0344 92706

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026