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Impact of Rehabilitation in Quality of Life in PD

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ClinicalTrials.gov Identifier: NCT02756676
Recruitment Status : Completed
First Posted : April 29, 2016
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Ilaria Zivi, 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.

Condition or disease Intervention/treatment
Parkinson Disease Procedure: Multidisciplinary Intensive Rehabilitation Treatment (MIRT)

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of an Intensive Multi-Disciplinary Rehabilitation Treatment on Quality Of Life in Subjects With Parkinson's Disease
Actual Study Start Date : April 2015
Primary Completion Date : September 2016
Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Rehabilitative treatment (MIRT)
Rehabilitative treatment MIRT consist in daily sessions of: motor treatment, occupational therapy and language speech therapy
Procedure: Multidisciplinary Intensive Rehabilitation Treatment (MIRT)
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 Measures :
  1. 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 Outcome Measures :
  1. Unified Parkinson's disease Rating Scale (UPDRS) [ Time Frame: 6 month ]
  2. six minute walking test (6MWT) [ Time Frame: 6 month ]
  3. Berg Balance Scale (BBS) [ Time Frame: 6 month ]
  4. Freezing of Gait Questionnaire (FoG) [ Time Frame: 6 month ]
  5. Parkinson Disease Disability Scale [ Time Frame: 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parkinson Disease
  • MMSE ≥ 24

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02756676


Locations
Italy
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
Gradevole ed Uniti, Como, Italy, 22015
Sponsors and Collaborators
Ospedale Generale Di Zona Moriggia-Pelascini
Investigators
Principal Investigator: Giuseppe Frazzitta, MD Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital - Gravedona ed Uniti (CO, Italy)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ilaria Zivi, MD, Ospedale Generale Di Zona Moriggia-Pelascini
ClinicalTrials.gov Identifier: NCT02756676     History of Changes
Other Study ID Numbers: QoL and rehab in PD
First Posted: April 29, 2016    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini:
Parkinson Disease
Quality of Life
Rehabilitation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases