Does Cognitive Impairment Affect Rehabilitation Outcome in Parkinson's Disease?

Ospedale Generale Di Zona Moriggia-Pelascini

Status: Completed

Conditions: Parkinson's Disease

Treatments: Behavioral: MIRT

Study type: Interventional

Funder types: Other

Identifiers

NCT02719470

Cognition and reahb in PD

Details and patient eligibility

About

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.

Full 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).

Enrollment: 438 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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438 participants in 5 patient groups

normal cognition

Experimental group

Description:

Group 1: patients with normal cognitive profile, assessed with MMSE (27 ≤ correct score ≤ 30) undergoing MIRT

Treatment:

Behavioral: MIRT

mildly impaired cognition

Experimental group

Description:

Group 3: patients with middle cognitive decline, assessed with MMSE (20 ≤ correct score \< 27) undergoing MIRT

Treatment:

Behavioral: MIRT

moderately-severely impaired cognition

Experimental group

Description:

Group 2: patients cognitive decline, assessed with MMSE (correct score \< 20) undergoing MIRT

Treatment:

Behavioral: MIRT

patients with normal executive functions

Experimental group

Description:

Group 4: patients with pathological executive functions, assessed with FAB (FAB ≥ 13.8) undergoing MIRT

Treatment:

Behavioral: MIRT

pathological executive functions

Experimental group

Description:

Group 5: patients with pathological executive functions, assessed with FAB (FAB \< 13.8) undergoing MIRT

Treatment:

Behavioral: MIRT