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Clinical Trials/NCT02756676
NCT02756676
Completed
N/A

Impact of an Intensive Multi-Disciplinary Rehabilitation Treatment on Quality Of Life in Subjects With Parkinson's Disease

Ospedale Generale Di Zona Moriggia-Pelascini1 site in 1 country250 target enrollmentApril 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Enrollment
250
Locations
1
Primary Endpoint
Parkinson Disease Questionnaire (PDQ39)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

This study is aimed to evaluate the impact of an intensive, multidisciplinary rehabilitative program on quality of life in patients with Parkinson's Disease.

Detailed Description

Parkinson's Disease (PD) is a progressive neurodegenerative disease clinically characterized by rigidity, bradykinesia and resting tremor. Beyond these symptoms the principal feature of this condition is the lost of habitual automatic movements and the disruption of different cognitive-motivational processes. These features are related to a pathological dopaminergic tone that alters the cortico-striatal pathways with several consequences on motor and emotional behaviours. Given its complexity PD impact very seriously on patients' quality of life (QoL). Dopamine replacement therapy (DRT) is the standard treatment for the motor symptom of PD and previous studies have demonstrated its positive effect on QoL. 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. In the last years, rehabilitation has been proposed as an effective and complementary treatment for the management of PD and several evidences highlighted the need of a multidisciplinary and intensive approach to achieve good results. To evaluate the impact of an intensive, multidisciplinary rehabilitation treatment (MIRT), on QoL of subjects with PD. Literature data showed that this type of treatment determine a positive effect on both motor and non-motor symptoms. Starting from these evidences, in this study the investigators have examined whether MIRT act positively on QoL and for how long this potential positive effect is maintained. 250 PD patients with Parkinson's Disease hospitalized for a 4-weeks MIRT were enrolled. PDQ39 was administered at enrolment, and at three points after discharge: at 1, 3 and 6 months. The investigators decided to evaluate QoL after homecoming in order to avoid an inpatient state bias. Other outcome measures were considered and assessed at the enrolment and at discharge: Unified Parkinson's Disease Scale (UPDRS), Parkinson Disease Disability Scale (PDDS), Berg Balance Scale (BBS), FOG (Freezing of Gait Questionnaire), 6MWT (6 minutes walking Test), Time Up and Go test (TUG). Cognitive and psychopathological status of patients was also assessed using Mini Mental State Examination (MMSE), Frontal Assessment Battery (FAB), State Trait Anxiety Inventory (STAY I-II), Beck Depression Inventory (BDI).

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
December 2016
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

  • Parkinson Disease
  • MMSE ≥ 24

Exclusion Criteria

  • Co-morbidity with other neurological disease
  • Visual and auditory dysfunctions

Outcomes

Primary Outcomes

Parkinson Disease Questionnaire (PDQ39)

Time Frame: 6 month

The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better QoL

Secondary Outcomes

  • Unified Parkinson's disease Rating Scale (UPDRS)(6 month)
  • six minute walking test (6MWT)(6 month)
  • Freezing of Gait Questionnaire (FoG)(6 month)
  • Parkinson Disease Disability Scale(6 month)
  • Berg Balance Scale (BBS)(6 month)

Study Sites (1)

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