NCT02731170

Brief Summary

this study is aimed to evaluate the effectiveness of an Multidisciplinary Intensive Rehabilitation Treatment in Advanced Stages of Parkinson's Disease. In the last years, several evidences highlighted the need of a multidisciplinary and intensive approach to achieve good results in early stage of disease. Hypothesis is that this approach is effectiveness also in moderate and advanced stages of disease

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
439

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 4, 2017

Status Verified

April 1, 2017

Enrollment Period

2.7 years

First QC Date

April 2, 2016

Last Update Submit

April 3, 2017

Conditions

Keywords

Parkinson DiseaseAdvanced StagesRehabilitation

Outcome Measures

Primary Outcomes (6)

  • Unified Parkinson Disease Rating Scale

    4 weeks

  • six-minutes walking test

    4 weeks

  • Time up and go Test

    4 weeks

  • Berg Balance Scale

    4 weeks

  • Freezing of Gait Questionnaire

    4 weeks

  • Parkinson's Disease Disability Scale

    4 weeks

Study Arms (1)

rehabilitation treatment (MIRT)

EXPERIMENTAL

MIRT consists of a 4-week physical therapy. daily sessions are subdivided in: motor treatment (2 hour), occupational therapy (1 hour) and speech Therapy (1 hour)

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

rehabilitation treatment (MIRT)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • clinica diagnosis of Parkinson Disease

You may not qualify if:

  • comorbidity with other neurological conditions

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

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 2, 2016

First Posted

April 7, 2016

Study Start

January 1, 2014

Primary Completion

September 1, 2016

Study Completion

June 1, 2017

Last Updated

April 4, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations