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Impact of Rehabilitation in Quality of Life in PD

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Multidisciplinary Intensive Rehabilitation Treatment (MIRT)
Sponsored by
Ospedale Generale Di Zona Moriggia-Pelascini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Quality of Life, Rehabilitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Parkinson Disease
  • MMSE ≥ 24

Exclusion Criteria:

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

Sites / Locations

  • Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rehabilitative treatment (MIRT)

Arm Description

Rehabilitative treatment MIRT consist in daily sessions of: motor treatment, occupational therapy and language speech therapy

Outcomes

Primary Outcome Measures

Parkinson Disease Questionnaire (PDQ39)
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

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

Full Information

First Posted
April 2, 2016
Last Updated
April 3, 2017
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
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1. Study Identification

Unique Protocol Identification Number
NCT02756676
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson Disease, Quality of Life, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rehabilitative treatment (MIRT)
Arm Type
Experimental
Arm Description
Rehabilitative treatment MIRT consist in daily sessions of: motor treatment, occupational therapy and language speech therapy
Intervention Type
Procedure
Intervention Name(s)
Multidisciplinary Intensive Rehabilitation Treatment (MIRT)
Intervention Description
MIRT consists of a 4-week physical therapy that entails four daily sessions, five days a week, in a hospital setting. The duration of each session is about one hour. The first session comprise cardiovascular warm-up activities, relaxation, muscle- stretching, exercises to improve the range of motion of spinal, pelvic and scapular joints, exercises to improve the functionality of the abdominal muscles, and postural changes in the supine position. The second session includes aerobic exercises to improve balance and gait using a stabilometric platform, treadmill plus, crossover and cycloergometer. The third is a session of occupational therapy to improve autonomy in daily living activities. The last session includes one hour of speech therapy.
Primary Outcome Measure Information:
Title
Parkinson Disease Questionnaire (PDQ39)
Description
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
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Unified Parkinson's disease Rating Scale (UPDRS)
Time Frame
6 month
Title
six minute walking test (6MWT)
Time Frame
6 month
Title
Berg Balance Scale (BBS)
Time Frame
6 month
Title
Freezing of Gait Questionnaire (FoG)
Time Frame
6 month
Title
Parkinson Disease Disability Scale
Time Frame
6 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Parkinson Disease MMSE ≥ 24 Exclusion Criteria: Co-morbidity with other neurological disease Visual and auditory dysfunctions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Frazzitta, MD
Organizational Affiliation
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital - Gravedona ed Uniti (CO, Italy)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
City
Gradevole ed Uniti
State/Province
Como
ZIP/Postal Code
22015
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29321141
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.
Results Reference
derived

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Impact of Rehabilitation in Quality of Life in PD

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