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Completed

NCT Number: NCT02719470

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

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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Gravedona Ed Uniti, Como, 22015, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MIRT

Behavioral

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 outcomes

  1. Unified Parkinson's Disease Rating Scale

    Time frame: 4 weeks

Secondary outcomes

  1. Berg Balance Scale

    Time frame: 4 weeks

Other outcomes

  1. Timed Up and Go Test

    Time frame: 4 weeks

  2. Six Minutes Walking Test

    Time frame: 4 weeks

  3. Parkinson's Disease Disability Scale

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Ospedale Generale Di Zona Moriggia-Pelascini

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 25, 2016
Registry last updated
Mar 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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