Effectiveness of Intensive Rehabilitation in Advanced Stages of Parkinson's Disease.
1 other identifier
interventional
439
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Jan 2014
Longer than P75 for not_applicable parkinson-disease
1 active site
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
CompletedFirst Submitted
Initial submission to the registry
April 2, 2016
CompletedFirst Posted
Study publicly available on registry
April 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedApril 4, 2017
April 1, 2017
2.7 years
April 2, 2016
April 3, 2017
Conditions
Keywords
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)
EXPERIMENTALMIRT 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)
Interventions
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
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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