NCT02719470

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 438 (actual)
• Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini · Academic / Other
• Sex: All
• Age: 60 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
BEHAVIORAL	MIRT	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

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2016-03-25
• Last updated: 2016-03-25

Locations

1 site across 1 country: Italy