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Impact of Rehabilitation in Quality of Life in PD

O

Ospedale Generale Di Zona Moriggia-Pelascini

Status

Completed

Conditions

Parkinson Disease

Treatments

Procedure: Multidisciplinary Intensive Rehabilitation Treatment (MIRT)

Study type

Interventional

Funder types

Other

Identifiers

NCT02756676
QoL and rehab in PD

Details and patient eligibility

About

This study is aimed to evaluate the impact of an intensive, multidisciplinary rehabilitative program on quality of life in patients with Parkinson's Disease.

Full 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).

Enrollment

250 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Parkinson Disease
  • MMSE ≥ 24

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

250 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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