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The Effect of a Motor-cognitive Rehabilitation on Attention in Parkinsonian Patients

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 Parkinson's disease, rehabilitation, attention, executive functions

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stage 2.5-3 according to the Hoehn & Yahr scale
  • pharmacological treatment for the last 8 weeks and during the hospitalization
  • Mini Mental State Examination (MMSE) ≥ 24

Exclusion Criteria:

  • any focal brain lesion detected in brain imaging studies (Computed Tomography or Magnetic Resonance Imaging) performed in the previous twelve months
  • disabling drug-induced dyskinesias
  • disturbing resting and/or action tremor, corresponding to scores 2 to 4 in the specific items of Unified Parkinson's Disease Rating Scale section 3 (UPDRS III)
  • behavioral disturbances (evaluated with Neuropsychiatric Inventory)
  • visual and auditory dysfunctions according to the general clinical evaluation and medical history

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 Type

Experimental

No Intervention

Arm Label

MIRT

healthy controls

Arm Description

MIRT consists of a 4-week physical therapy that entails four daily sessions, five days a week, in a hospital setting. The first session comprise cardiovascular warm-up activities, relaxation, muscle-stretching, exercises to improve the range of motion of spinal, pelvic and scapular joints, exercises to improve the functionality of the abdominal muscles, and postural changes in the supine position. The second session includes aerobic exercises to improve balance and gait using a stabilometric platform, treadmill plus, crossover and cycloergometer. All the exercises are aerobic. The third is a session of occupational therapy to improve autonomy in day living activities. The last session includes one hour of speech therapy.

we assessed the attentive Reaction Times in healthy controls, that don't receive rehabilitative treatment

Outcomes

Primary Outcome Measures

Multiple Choice Reaction Time task
The task consisted of 40 trials. The target was a number (1, 2, 3) whose presentation, on the centre of the screen, was randomized. Each number was associated to a different response buttons . In each single trial subjects had to press as quickly as possible the response button associated with the number that appeared on the screen. We evaluated the accuracy of response and recorded the time between the appearance of target and the subject's response.

Secondary Outcome Measures

Simple Choice Reaction Time task
The task consisted of 40 trials. In each single trial, the subjects had to press the response button as quickly as possible when a red circle appeared on the screen. The appearance of targets was mixed to a variable number of distractors consisting in single green circles. Targets and distractors could appear in different positions of the screen at irregular intervals (1-3 seconds). Distractors remained on the screen for 500 ms, while the target disappeared with the subject's response. We evaluated the accuracy of response and recorded the time between the appearance of target and the subject's response.

Full Information

First Posted
March 6, 2016
Last Updated
July 28, 2016
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
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1. Study Identification

Unique Protocol Identification Number
NCT02727257
Brief Title
The Effect of a Motor-cognitive Rehabilitation on Attention in Parkinsonian Patients
Official Title
The Effect of a Motor-cognitive Rehabilitation on Attention in Parkinsonian Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (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 this study the Investigators explore two questions: if the attentive reaction times differs in parkinsonian patients from health controls and if an intensive, focused and aerobic rehabilitation program (Multidisciplinary Intensive Rehabilitation Treatment - MIRT) tailored mainly for motor problems, could have a specific positive effect on multiple choices Reaction Times (RTs) as an indirect marker for an effect on attentional-executive frontal circuits. The hypothesis is that the MIRT could have a positive effect on the top-down control mechanisms, since the continuous feedback given by physiotherapist during exercises and the use of cues and devices (such as treadmill plus and stabilometric platform), stimulate the selective attention processes that enable goal-directed, internally-driven decision, helping the patients to overcome externally-driven decision based on stimulus salience and novelty
Detailed Description
Objective: To evaluate the attentive performances in Parkinsonians in comparison with healthy controls and the effect of motor-cognitive rehabilitation program on attention. Methods: 103 Parkinsonians (stage 2,5-3 H&Y) hospitalized for a 4-week Multidisciplinary Intensive Rehabilitation Treatment and 34 healthy controls were enrolled. All subjects underwent three different attentive tasks: visual reaction times, auditory reaction times and multiple choices reaction times tasks. To evaluate the effect of rehabilitation on attention, patients performed the same battery at discharge. To investigate the effects of MIRT on motor functions and quality of life we also assessed UPDRS III, Timed Up and Go test and Parkinson's Disease Questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, rehabilitation, attention, executive functions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIRT
Arm Type
Experimental
Arm Description
MIRT consists of a 4-week physical therapy that entails four daily sessions, five days a week, in a hospital setting. The first session comprise cardiovascular warm-up activities, relaxation, muscle-stretching, exercises to improve the range of motion of spinal, pelvic and scapular joints, exercises to improve the functionality of the abdominal muscles, and postural changes in the supine position. The second session includes aerobic exercises to improve balance and gait using a stabilometric platform, treadmill plus, crossover and cycloergometer. All the exercises are aerobic. The third is a session of occupational therapy to improve autonomy in day living activities. The last session includes one hour of speech therapy.
Arm Title
healthy controls
Arm Type
No Intervention
Arm Description
we assessed the attentive Reaction Times in healthy controls, that don't receive rehabilitative treatment
Intervention Type
Procedure
Intervention Name(s)
MIRT
Intervention Description
MIRT consists of a 4-week physical therapy that entails four daily sessions, five days a week, in a hospital setting. The duration of each session, including recovery periods, is about one hour. The first session comprise cardiovascular warm-up activities, relaxation, muscle-stretching, exercises to improve the range of motion of spinal, pelvic and scapular joints, exercises to improve the functionality of the abdominal muscles, and postural changes in the supine position. The second session includes aerobic exercises to improve balance and gait using a stabilometric platform, treadmill plus, crossover and cycloergometer. The third is a session of occupational therapy to improve autonomy in day living activities. The last session includes one hour of speech therapy.
Primary Outcome Measure Information:
Title
Multiple Choice Reaction Time task
Description
The task consisted of 40 trials. The target was a number (1, 2, 3) whose presentation, on the centre of the screen, was randomized. Each number was associated to a different response buttons . In each single trial subjects had to press as quickly as possible the response button associated with the number that appeared on the screen. We evaluated the accuracy of response and recorded the time between the appearance of target and the subject's response.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Simple Choice Reaction Time task
Description
The task consisted of 40 trials. In each single trial, the subjects had to press the response button as quickly as possible when a red circle appeared on the screen. The appearance of targets was mixed to a variable number of distractors consisting in single green circles. Targets and distractors could appear in different positions of the screen at irregular intervals (1-3 seconds). Distractors remained on the screen for 500 ms, while the target disappeared with the subject's response. We evaluated the accuracy of response and recorded the time between the appearance of target and the subject's response.
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Auditory Reaction Time task
Description
The task consisted of 40 trials. In each single trial the subjects had to press a response button as quickly as possible at the presentation of the target that consisted of an acoustic stimulus (intensity of 94 dbA) presented at irregular intervals (1-3 seconds). The stimulus ended after the subject's response. The times between the presentation of the target and the subject's response were recorded.
Time Frame
4 weeks
Title
Visual Reaction Time task
Description
The task consisted of 40 trials. In each single trial, the subjects had to press a response button as quickly as possible at the appearance of the target that disappeared after the subject's response. Target was a red circle that appeared on the centre of screen at irregular intervals (1-3 seconds). The times between the appearance of the target and the subject's response were recorded.
Time Frame
4 weeks
Title
Unified Parkinson's disease Rating Scale
Time Frame
4 weeks
Title
Parkinson Disease Questionnaire - 39
Time Frame
4 weeks
Title
Timed Up and Go Test
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stage 2.5-3 according to the Hoehn & Yahr scale pharmacological treatment for the last 8 weeks and during the hospitalization Mini Mental State Examination (MMSE) ≥ 24 Exclusion Criteria: any focal brain lesion detected in brain imaging studies (Computed Tomography or Magnetic Resonance Imaging) performed in the previous twelve months disabling drug-induced dyskinesias disturbing resting and/or action tremor, corresponding to scores 2 to 4 in the specific items of Unified Parkinson's Disease Rating Scale section 3 (UPDRS III) behavioral disturbances (evaluated with Neuropsychiatric Inventory) visual and auditory dysfunctions according to the general clinical evaluation and medical history
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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The Effect of a Motor-cognitive Rehabilitation on Attention in Parkinsonian Patients

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