Clinical trial NCT02756676: Impact of Rehabilitation in Quality of Life in PD
Official title: Impact of an Intensive Multi-Disciplinary Rehabilitation Treatment on Quality Of Life in Subjects With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Quality of Life
Rehabilitation
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 250
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 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).

Eligibility criteria: Inclusion Criteria:

* Parkinson Disease
* MMSE ≥ 24

Exclusion Criteria:

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

Primary outcomes:
measure: Parkinson Disease Questionnaire (PDQ39)
timeFrame: 6 month
Secondary outcomes:
measure: Unified Parkinson's disease Rating Scale (UPDRS)
timeFrame: 6 month
measure: six minute walking test (6MWT)
timeFrame: 6 month
measure: Berg Balance Scale (BBS)
timeFrame: 6 month
measure: Freezing of Gait Questionnaire (FoG)
timeFrame: 6 month
measure: Parkinson Disease Disability Scale
timeFrame: 6 month
Other outcomes:
Locations:
city: Gradevole ed Uniti
country: Italy
facility: Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
state: Como
Study officials:
affiliation: Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital - Gravedona ed Uniti (CO, Italy)
name: Giuseppe Frazzitta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ferrazzoli D, Ortelli P, Zivi I, Cian V, Urso E, Ghilardi MF, Maestri R, Frazzitta G. Efficacy of intensive multidisciplinary rehabilitation in Parkinson's disease: a randomised controlled study. J Neurol Neurosurg Psychiatry. 2018 Aug;89(8):828-835. doi: 10.1136/jnnp-2017-316437. Epub 2018 Jan 10.