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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02731170
• Other study ID #: Rehabilitation and PD
• Status: Recruiting
• Phase: N/A
• First received: April 2, 2016
• Last updated: April 3, 2017
• Start date: January 2014
• Est. completion date: June 2017

Study information

• Verified date: April 2017
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: Giuseppe Frazzitta
• Phone: +393442719916
• Email: ortellipaola73[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 439
• Est. completion date: June 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

clinica diagnosis of Parkinson Disease

Exclusion Criteria:

comorbidity with other neurological conditions

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• MIRT
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

Locations

Country	Name	City	State
Italy	Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital	Gravedona ed Uniti	Como

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Parkinson Disease Rating Scale		4 weeks
Primary	six-minutes walking test		4 weeks
Primary	Time up and go Test		4 weeks
Primary	Berg Balance Scale		4 weeks
Primary	Freezing of Gait Questionnaire		4 weeks
Primary	Parkinson's Disease Disability Scale		4 weeks