Impact of Rehabilitation in Quality of Life in PD

NCT ID: NCT02756676

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-12-31

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).

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rehabilitative treatment (MIRT)

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

Group Type: EXPERIMENTAL

Multidisciplinary Intensive Rehabilitation Treatment (MIRT)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Parkinson Disease
• MMSE ≥ 24

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Generale Di Zona Moriggia-Pelascini

OTHER

Sponsor Role: lead

Responsible Party

Ilaria Zivi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giuseppe Frazzitta, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital - Gravedona ed Uniti (CO, Italy)

Locations

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

Gradevole Ed Uniti, Como, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 29321141 (View on PubMed)

Other Identifiers

QoL and rehab in PD

Identifier Type: -

Identifier Source: org_study_id