NCT02719470

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
438

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

March 6, 2016

Last Update Submit

March 24, 2016

Conditions

Parkinson's Disease

Keywords

Cognition ImpairmentRehabilitationParkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • Unified Parkinson's Disease Rating Scale

    4 weeks

Secondary Outcomes (1)

  • Berg Balance Scale

    4 weeks

Other Outcomes (3)

  • Timed Up and Go Test

    4 weeks

  • Six Minutes Walking Test

    4 weeks

  • Parkinson's Disease Disability Scale

    4 weeks

Study Arms (5)

normal cognition

EXPERIMENTAL

Group 1: patients with normal cognitive profile, assessed with MMSE (27 ≤ correct score ≤ 30) undergoing MIRT

Behavioral: MIRT

mildly impaired cognition

EXPERIMENTAL

Group 3: patients with middle cognitive decline, assessed with MMSE (20 ≤ correct score \< 27) undergoing MIRT

Behavioral: MIRT

moderately-severely impaired cognition

EXPERIMENTAL

Group 2: patients cognitive decline, assessed with MMSE (correct score \< 20) undergoing MIRT

Behavioral: MIRT

patients with normal executive functions

EXPERIMENTAL

Group 4: patients with pathological executive functions, assessed with FAB (FAB ≥ 13.8) undergoing MIRT

Behavioral: MIRT

pathological executive functions

EXPERIMENTAL

Group 5: patients with pathological executive functions, assessed with FAB (FAB \< 13.8) undergoing MIRT

Behavioral: MIRT

Interventions

MIRTBEHAVIORAL

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

mildly impaired cognitionmoderately-severely impaired cognitionnormal cognitionpathological executive functionspatients with normal executive functions

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinsonian patients according to the UK Brain Bank criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Gravedona Ed Uniti, Como, 22015, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Giuseppe Frazzitta, MD

    Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital - Gravedona ed Uniti (CO, Italy)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 6, 2016

First Posted

March 25, 2016

Study Start

January 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 25, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)