Parkinson DiseaseNCT02731170
Effectiveness of Intensive Rehabilitation in Advanced Stages of Parkinson's Disease.
A study testing MIRT in people with Parkinson Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- MIRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 439 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clinica diagnosis of Parkinson Disease
Who cannot join
- comorbidity with other neurological conditions
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
Gravedona Ed Uniti, Como, 22015
Giuseppe Frazzitta, MD, +39034492564, frazzittag62@gmail.com
About this study
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
Read the detailed description
Parkinson's Disease (PD) is a progressive neurodegenerative disease clinically characterized by motor and non-motor symptoms.
Dopamine replacement therapy (DRT) is the standard treatment for the motor symptom of PD, however DRT does not reduce axial PD symptoms such as freezing of gait, postural instability and balance disturbances. Further, long-term DRT could negatively impact on cognitive and motivational functions and leads to different motor and behavioural side effects. Therefore, the pharmacological approach becomes less effective in the moderate and advanced stages of disease.
The investigators testing the hypothesis that this approach is effectiveness also in moderate and advanced stages of disease In according with Hoehn and Yahr scale (H\&Y) we identified 353 parkinsonian patients on stage 3, 79 subjects on stage 4 and 7 subjects on stage 5.
Clinical scores were assessed at baseline and after 4 weeks by neurologists and physiotherapists expert in movement disorders. All evaluations were performed in the morning, one hour after taking drugs. The assessment included: Unified Parkinson's Disease Rating Scale (UPDRS), for clinical evaluation, Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Six Minutes Walking Test (6MWT), Freezing of Gait Questionnaire (FOGQ) and Abnormal Involuntary Movements Scale (AIMS) for motor symptoms evaluation and, finally, Parkinson's Disease Disability Scale (PDDS), for evaluation of the functional impact of the disease. Since in the advanced stages of PD one of the most troublesome complication includes cognitive disorders, a Neuropsychologist performed a cognitive assessment at the admission. The neuropsychological profile was explored using the Mini Mental State Examination (MMSE), a tool for screening of cognitive impairment, and the Frontal Assessment Battery (FAB) for the evaluation of frontal lobe dysfunctions.
- Conditions
- Parkinson Disease
- Being tested
- MIRT
- Keywords
- Parkinson Disease, Advanced Stages, Rehabilitation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRTBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: MIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson Disease Rating Scale
Measured: 4 weeks
six-minutes walking test
Measured: 4 weeks
Time up and go Test
Measured: 4 weeks
Berg Balance Scale
Measured: 4 weeks
Freezing of Gait Questionnaire
Measured: 4 weeks
Parkinson's Disease Disability Scale
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startJan 2014
- Primary completionSep 2016
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 439 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-Pelascini
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilaria Zivi, Ospedale Generale Di Zona Moriggia-Pelascini
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731170
- Sponsor's protocol ID
- Rehabilitation and PD
- Status last verified
- Apr 2017
- First submitted
- 2 Apr 2016
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intensive Rehabilitation in Advanced Stages of Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT02731170
- Acronym / sponsor ID
- Rehabilitation and PD
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Advanced Stages, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 439 participants (estimated)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 7 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Parkinson's Disease (PD) is a progressive neurodegenerative disease clinically characterized by motor and non-motor symptoms.
Dopamine replacement therapy (DRT) is the standard treatment for the motor symptom of PD, however DRT does not reduce axial PD symptoms such as freezing of gait, postural instability and balance disturbances. Further, long-term DRT could negatively impact on cognitive and motivational functions and leads to different motor and behavioural side effects. Therefore, the pharmacological approach becomes less effective in the moderate and advanced stages of disease.
The investigators testing the hypothesis that this approach is effectiveness also in moderate and advanced stages of disease In according with Hoehn and Yahr scale (H\&Y) we identified 353 parkinsonian patients on stage 3, 79 subjects on stage 4 and 7 subjects on stage 5.
Clinical scores were assessed at baseline and after 4 weeks by neurologists and physiotherapists expert in movement disorders. All evaluations were performed in the morning, one hour after taking drugs. The assessment included: Unified Parkinson's Disease Rating Scale (UPDRS), for clinical evaluation, Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Six Minutes Walking Test (6MWT), Freezing of Gait Questionnaire (FOGQ) and Abnormal Involuntary Movements Scale (AIMS) for motor symptoms evaluation and, finally, Parkinson's Disease Disability Scale (PDDS), for evaluation of the functional impact of the disease. Since in the advanced stages of PD one of the most troublesome complication includes cognitive disorders, a Neuropsychologist performed a cognitive assessment at the admission. The neuropsychological profile was explored using the Mini Mental State Examination (MMSE), a tool for screening of cognitive impairment, and the Frontal Assessment Battery (FAB) for the evaluation of frontal lobe dysfunctions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rehabilitation treatment (MIRT) | Experimental | Behavioral: MIRTMIRT 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- clinica diagnosis of Parkinson Disease
Key exclusion criteria (1 listed)
- comorbidity with other neurological conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIRTMIRT 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 | Behavioural | rehabilitation treatment (MIRT) |
Primary outcome
Unified Parkinson Disease Rating Scale
Time frame: 4 weeks
six-minutes walking test
Time frame: 4 weeks
Time up and go Test
Time frame: 4 weeks
Berg Balance Scale
Time frame: 4 weeks
Freezing of Gait Questionnaire
Time frame: 4 weeks
Parkinson's Disease Disability Scale
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIRT in people with Parkinson Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Frazzitta (+393442719916, ortellipaola73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson Disease Rating Scale (time frame: 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.