Skip to main content
Clinical Trials/NCT02719470
NCT02719470
Completed
Not Applicable

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

Ospedale Generale Di Zona Moriggia-Pelascini1 site in 1 country438 target enrollmentJanuary 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson's Disease
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Enrollment
438
Locations
1
Primary Endpoint
Unified Parkinson's Disease Rating Scale
Status
Completed
Last Updated
10 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
Responsible Party
Principal Investigator
Principal Investigator

Ilaria Zivi

MD

Ospedale Generale Di Zona Moriggia-Pelascini

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

Outcomes

Primary Outcomes

Unified Parkinson's Disease Rating Scale

Time Frame: 4 weeks

Secondary Outcomes

  • Berg Balance Scale(4 weeks)

Study Sites (1)

Loading locations...

Similar Trials