Impact of Rehabilitation in Quality of Life in PD

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Procedure: Multidisciplinary Intensive Rehabilitation Treatment (MIRT)

• Registration Number: NCT02756676
• Lead Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

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).

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-04-02
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-29
• Primary Completion: 2016-09
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-03
• Last Update Posted: 2017-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Parkinson Disease
• MMSE ≥ 24

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rehabilitative treatment (MIRT)	Multidisciplinary Intensive Rehabilitation Treatment (MIRT)	Rehabilitative treatment MIRT consist in daily sessions of: motor treatment, occupational therapy and language speech therapy

Primary Outcome Measures

Name	Time	Method
Parkinson Disease Questionnaire (PDQ39)	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital; 🇮🇹 Gradevole ed Uniti, Como, Italy