NCT02756676

Brief Summary

This study is aimed to evaluate the impact of an intensive, multidisciplinary rehabilitative program on quality of life in patients with Parkinson's Disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2015

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

April 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 2, 2016

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

1.4 years

First QC Date

April 2, 2016

Last Update Submit

April 3, 2017

Conditions

Parkinson Disease

Keywords

Parkinson DiseaseQuality of LifeRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Parkinson Disease Questionnaire (PDQ39)

    The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month Each dimension total score range from 0 (never have difficulty) to 100 (always have difficulty). Lower scores reflect better QoL

    6 month

Secondary Outcomes (5)

  • Unified Parkinson's disease Rating Scale (UPDRS)

    6 month

  • six minute walking test (6MWT)

    6 month

  • Berg Balance Scale (BBS)

    6 month

  • Freezing of Gait Questionnaire (FoG)

    6 month

  • Parkinson Disease Disability Scale

    6 month

Study Arms (1)

Rehabilitative treatment (MIRT)

EXPERIMENTAL

Rehabilitative treatment MIRT consist in daily sessions of: motor treatment, occupational therapy and language speech therapy

Procedure: Multidisciplinary Intensive Rehabilitation Treatment (MIRT)

Interventions

Multidisciplinary Intensive Rehabilitation Treatment (MIRT)PROCEDURE

MIRT consists of a 4-week physical therapy that entails four daily sessions, five days a week, in a hospital setting. The duration of each session is about one hour. The first session comprise cardiovascular warm-up activities, relaxation, muscle- stretching, exercises to improve the range of motion of spinal, pelvic and scapular joints, exercises to improve the functionality of the abdominal muscles, and postural changes in the supine position. The second session includes aerobic exercises to improve balance and gait using a stabilometric platform, treadmill plus, crossover and cycloergometer. The third is a session of occupational therapy to improve autonomy in daily living activities. The last session includes one hour of speech therapy.

Rehabilitative treatment (MIRT)

Eligibility Criteria

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

You may qualify if:

  • Parkinson Disease
  • MMSE ≥ 24

You may not qualify if:

  • Co-morbidity with other neurological disease
  • Visual and auditory dysfunctions

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

Gradevole Ed Uniti, Como, 22015, Italy

Location

Related Publications (1)

  • Ferrazzoli D, Ortelli P, Zivi I, Cian V, Urso E, Ghilardi MF, Maestri R, Frazzitta G. Efficacy of intensive multidisciplinary rehabilitation in Parkinson's disease: a randomised controlled study. J Neurol Neurosurg Psychiatry. 2018 Aug;89(8):828-835. doi: 10.1136/jnnp-2017-316437. Epub 2018 Jan 10.

    PMID: 29321141DERIVED

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
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 29, 2016

Study Start

April 1, 2015

Primary Completion

September 1, 2016

Study Completion

December 1, 2016

Last Updated

April 5, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)