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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
MIRT
Sponsored by
Ospedale Generale Di Zona Moriggia-Pelascini
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Cognition Impairment, Rehabilitation, Parkinson's Disease

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

normal cognition

mildly impaired cognition

moderately-severely impaired cognition

patients with normal executive functions

pathological executive functions

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Unified Parkinson's Disease Rating Scale

Secondary Outcome Measures

Berg Balance Scale

Full Information

First Posted
March 6, 2016
Last Updated
March 24, 2016
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
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1. Study Identification

Unique Protocol Identification Number
NCT02719470
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Cognition Impairment, Rehabilitation, Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
438 (Actual)

8. Arms, Groups, and Interventions

Arm Title
normal cognition
Arm Type
Experimental
Arm Description
Group 1: patients with normal cognitive profile, assessed with MMSE (27 ≤ correct score ≤ 30) undergoing MIRT
Arm Title
mildly impaired cognition
Arm Type
Experimental
Arm Description
Group 3: patients with middle cognitive decline, assessed with MMSE (20 ≤ correct score < 27) undergoing MIRT
Arm Title
moderately-severely impaired cognition
Arm Type
Experimental
Arm Description
Group 2: patients cognitive decline, assessed with MMSE (correct score < 20) undergoing MIRT
Arm Title
patients with normal executive functions
Arm Type
Experimental
Arm Description
Group 4: patients with pathological executive functions, assessed with FAB (FAB ≥ 13.8) undergoing MIRT
Arm Title
pathological executive functions
Arm Type
Experimental
Arm Description
Group 5: patients with pathological executive functions, assessed with FAB (FAB < 13.8) undergoing MIRT
Intervention Type
Behavioral
Intervention Name(s)
MIRT
Intervention Description
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
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Timed Up and Go Test
Time Frame
4 weeks
Title
Six Minutes Walking Test
Time Frame
4 weeks
Title
Parkinson's Disease Disability Scale
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Frazzitta, MD
Organizational Affiliation
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital - Gravedona ed Uniti (CO, Italy)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
City
Gravedona ed Uniti
State/Province
Como
ZIP/Postal Code
22015
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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

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