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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719470
• Other study ID #: Cognition and reahb in PD
• Status: Completed
• Phase: N/A
• First received: March 6, 2016
• Last updated: March 24, 2016
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: March 2016
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Local Scientific Committee and Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
Italy	Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital	Gravedona ed Uniti	Como

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Timed Up and Go Test		4 weeks	Yes
Other	Six Minutes Walking Test		4 weeks	Yes
Other	Parkinson's Disease Disability Scale		4 weeks	Yes
Primary	Unified Parkinson's Disease Rating Scale		4 weeks	Yes
Secondary	Berg Balance Scale		4 weeks	Yes