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

Overview

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 Title of Study: “Does Cognitive Impairment Affect Rehabilitation Outcome in Parkinson’s Disease?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: May 2015

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).

Interventions

  • Behavioral: MIRT
    • MIRT consists of a 4-week physical therapy, in a hospital setting, which entails four daily sessions for five days and one hour of physical exercise on the sixth day. The duration of each session is about one hour. The first session consists of a one-to-one session with physical therapist involving muscle stretching. The second session includes aerobic exercises to improve balance and gait using different devices: a stabilometric platform, treadmill plus, crossover and cycloergometer. The third is a session of occupational therapy to improve autonomy in everyday activities. The last session includes one hour of speech therapy

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Unified Parkinson’s Disease Rating Scale
    • Time Frame: 4 weeks

Secondary Measures

  • Berg Balance Scale
    • Time Frame: 4 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ospedale Generale Di Zona Moriggia-Pelascini
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ilaria Zivi, MD – Ospedale Generale Di Zona Moriggia-Pelascini
  • Overall Official(s)
    • Giuseppe Frazzitta, MD, Principal Investigator, Department of Parkinson’s Disease and Brain Injury Rehabilitation, of the ‘Moriggia-Pelascini’ Hospital – Gravedona ed Uniti (CO, Italy)

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