Clinical trial NCT02727257: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
rehabilitation
attention
executive functions
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 103
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Multiple Choice Reaction Time task
timeFrame: 4 weeks
Secondary outcomes:
measure: Simple Choice Reaction Time task
timeFrame: 4 weeks
Other outcomes:
measure: Auditory Reaction Time task
timeFrame: 4 weeks
measure: Visual Reaction Time task
timeFrame: 4 weeks
measure: Unified Parkinson's disease Rating Scale
timeFrame: 4 weeks
measure: Parkinson Disease Questionnaire - 39
timeFrame: 4 weeks
measure: Timed Up and Go Test
timeFrame: 4 weeks
Locations:
city: Gravedona ed Uniti
country: Italy
facility: Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
state: Como
Study officials:
affiliation: Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital - Gravedona ed Uniti (CO, Italy)
name: Giuseppe Frazzitta, MD
role: PRINCIPAL_INVESTIGATOR
References: