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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02719470
Enrollment
438
Registered
2016-03-25
Start date
2014-01-31
Completion date
2015-05-31
Last updated
2016-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Cognition Impairment, Rehabilitation, Parkinson's Disease

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).

Interventions

BEHAVIORALMIRT

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

Sponsors

Ospedale Generale Di Zona Moriggia-Pelascini
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Unified Parkinson's Disease Rating Scale4 weeks

Secondary

MeasureTime frame
Berg Balance Scale4 weeks

Other

MeasureTime frame
Timed Up and Go Test4 weeks
Six Minutes Walking Test4 weeks
Parkinson's Disease Disability Scale4 weeks

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026