Clinical trial NCT02719470: Does Cognitive Impairment Affect Rehabilitation Outcome in Parkinson's Disease?
Official title: Does Cognitive Impairment Affect Rehabilitation Outcome in Parkinson's Disease?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Cognition Impairment
Rehabilitation
Parkinson's Disease
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2016-03-25
Enrollment: 438
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In order to explore the question how an intensive, goal-based and aerobic rehabilitation treatment, addressed to act on motor and mental aspects, affects motor and functional symptoms in PD patients with normal cognition and with different level of cognitive impairment. Hypothesis is that a specific rehabilitation program based on motor-cognitive training and repetition, can affect positively the rehabilitation outcome regardless of baseline cognitive profile.

Detailed description: Objective: This study is aimed to evaluate the impact of cognitive decline on rehabilitation outcomes in Parkinson's disease (PD). While cognitive status is considered as a determinant of rehabilitation outcome, no studies about this issue have been performed before.

Methods: 438 PD patients hospitalized for a 4-weeks Multidisciplinary Intensive Rehabilitation Treatment (MIRT) were enrolled. According to Mini Mental State Examination (MMSE), patients were divided into: normal cognition (MMSE 27-30), mild cognitive impairment (MMSE 21-26), moderate or severe cognitive impairment (MMSE ≤ 20). According to Frontal Assessment Battery (FAB), subjects were divided into patients with normal (FAB ≥ 13.8) and pathological (FAB \< 13.8) score. The outcomes measures were: Unified Parkinson's Disease Rating Scale (UPDRS), Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Six Minutes Walking Test (6MWT), Parkinson's Disease Disability Scale (PDDS).

Eligibility criteria: Inclusion Criteria:

* Parkinsonian patients according to the UK Brain Bank criteria

Exclusion Criteria:

* Major stroke, possible hydrocephalus or brain tumor observed on CT scan or brain MRI
* Major depression, active psychosis or clinically significant psychiatric disorders
* Visual or auditory disturbances that prevent the neuropsychological assessment
* The increase in drug dosage during hospitalization

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: 4 weeks
Other outcomes:
measure: Timed Up and Go Test
timeFrame: 4 weeks
measure: Six Minutes Walking Test
timeFrame: 4 weeks
measure: Parkinson's Disease Disability Scale
timeFrame: 4 weeks
Locations:
city: Gravedona ed Uniti
country: Italy
facility: Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
state: Como
Study officials:
affiliation: Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital - Gravedona ed Uniti (CO, Italy)
name: Giuseppe Frazzitta, MD
role: PRINCIPAL_INVESTIGATOR
References: