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

Not Applicable

Completed

• Conditions: Parkinson's Disease
• Interventions: Behavioral: MIRT

• Registration Number: NCT02719470
• Lead Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

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).

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-03
• Study First Submitted: 2016-03-06
• Study First Submitted QC: 2016-03-24
• Last Update Submitted: 2016-03-24
• Study First Posted: 2016-03-25
• Last Update Posted: 2016-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 438

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with normal executive functions	MIRT	Group 4: patients with pathological executive functions, assessed with FAB (FAB ≥ 13.8) undergoing MIRT
moderately-severely impaired cognition	MIRT	Group 2: patients cognitive decline, assessed with MMSE (correct score \< 20) undergoing MIRT
pathological executive functions	MIRT	Group 5: patients with pathological executive functions, assessed with FAB (FAB \< 13.8) undergoing MIRT
normal cognition	MIRT	Group 1: patients with normal cognitive profile, assessed with MMSE (27 ≤ correct score ≤ 30) undergoing MIRT
mildly impaired cognition	MIRT	Group 3: patients with middle cognitive decline, assessed with MMSE (20 ≤ correct score \< 27) undergoing MIRT

Primary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale	4 weeks

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale	4 weeks

Trial Locations

Locations (1)

Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital; 🇮🇹 Gravedona ed Uniti, Como, Italy