Parkinson's DiseaseNCT02719470
Does Cognitive Impairment Affect Rehabilitation Outcome in Parkinson's Disease?
A study testing MIRT in people with Parkinson's Disease, run by Ospedale Generale Di Zona Moriggia-Pelascini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Parkinson's 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
- 438 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2014to May 2015
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinsonian patients according to the UK Brain Bank criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital
Gravedona Ed Uniti, Como, 22015
About this study
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.
Read the detailed description
Objective: This study is aimed to evaluate the impact of cognitive decline on rehabilitation outcomes in Parkinson's disease (PD). While cognitive status is considered as a determinant of rehabilitation outcome, no studies about this issue have been performed before.
Methods: 438 PD patients hospitalized for a 4-weeks Multidisciplinary Intensive Rehabilitation Treatment (MIRT) were enrolled. According to Mini Mental State Examination (MMSE), patients were divided into: normal cognition (MMSE 27-30), mild cognitive impairment (MMSE 21-26), moderate or severe cognitive impairment (MMSE ≤ 20). According to Frontal Assessment Battery (FAB), subjects were divided into patients with normal (FAB ≥ 13.8) and pathological (FAB < 13.8) score. The outcomes measures were: Unified Parkinson's Disease Rating Scale (UPDRS), Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Six Minutes Walking Test (6MWT), Parkinson's Disease Disability Scale (PDDS).
- Conditions
- Parkinson's Disease
- Being tested
- MIRT
- Keywords
- Cognition Impairment, Rehabilitation, Parkinson's Disease
- 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 |
|---|---|---|
| normal cognition | Experimental | Group 1: patients with normal cognitive profile, assessed with MMSE (27 ≤ correct score ≤ 30) undergoing MIRT Receives: Behavioral: MIRT |
| mildly impaired cognition | Experimental | Group 3: patients with middle cognitive decline, assessed with MMSE (20 ≤ correct score < 27) undergoing MIRT Receives: Behavioral: MIRT |
| moderately-severely impaired cognition | Experimental | Group 2: patients cognitive decline, assessed with MMSE (correct score < 20) undergoing MIRT Receives: Behavioral: MIRT |
| patients with normal executive functions | Experimental | Group 4: patients with pathological executive functions, assessed with FAB (FAB ≥ 13.8) undergoing MIRT Receives: Behavioral: MIRT |
| pathological executive functions | Experimental | Group 5: patients with pathological executive functions, assessed with FAB (FAB < 13.8) undergoing MIRT Receives: Behavioral: MIRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale
Measured: 4 weeks
Secondary outcomes (1)
Berg Balance 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 posted25 Mar 2016 (estimated)
- Study startJan 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 438 participants (actual)
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
- Investigators
- Giuseppe Frazzitta, MD, Principal investigator, Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital - Gravedona ed Uniti (CO, Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719470
- Sponsor's protocol ID
- Cognition and reahb in PD
- Status last verified
- Mar 2016
- First submitted
- 6 Mar 2016
- Last updated
- 25 Mar 2016
- 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 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Cognitive Impairment Affect Rehabilitation Outcome in Parkinson's Disease?
- ClinicalTrials.gov ID
- NCT02719470
- Acronym / sponsor ID
- Cognition and reahb in PD
- Conditions
- Parkinson's Disease
- Keywords
- Cognition Impairment, Rehabilitation, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- Ospedale Generale Di Zona Moriggia-PelasciniUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Mar 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.
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.
Detailed description
Objective: This study is aimed to evaluate the impact of cognitive decline on rehabilitation outcomes in Parkinson's disease (PD). While cognitive status is considered as a determinant of rehabilitation outcome, no studies about this issue have been performed before.
Methods: 438 PD patients hospitalized for a 4-weeks Multidisciplinary Intensive Rehabilitation Treatment (MIRT) were enrolled. According to Mini Mental State Examination (MMSE), patients were divided into: normal cognition (MMSE 27-30), mild cognitive impairment (MMSE 21-26), moderate or severe cognitive impairment (MMSE ≤ 20). According to Frontal Assessment Battery (FAB), subjects were divided into patients with normal (FAB ≥ 13.8) and pathological (FAB < 13.8) score. The outcomes measures were: Unified Parkinson's Disease Rating Scale (UPDRS), Berg Balance Scale (BBS), Timed Up and Go Test (TUG), Six Minutes Walking Test (6MWT), Parkinson's Disease Disability Scale (PDDS).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| normal cognition | Experimental | Behavioral: MIRTGroup 1: patients with normal cognitive profile, assessed with MMSE (27 ≤ correct score ≤ 30) undergoing MIRT |
| mildly impaired cognition | Experimental | Behavioral: MIRTGroup 3: patients with middle cognitive decline, assessed with MMSE (20 ≤ correct score < 27) undergoing MIRT |
| moderately-severely impaired cognition | Experimental | Behavioral: MIRTGroup 2: patients cognitive decline, assessed with MMSE (correct score < 20) undergoing MIRT |
| patients with normal executive functions | Experimental | Behavioral: MIRTGroup 4: patients with pathological executive functions, assessed with FAB (FAB ≥ 13.8) undergoing MIRT |
| pathological executive functions | Experimental | Behavioral: MIRTGroup 5: patients with pathological executive functions, assessed with FAB (FAB < 13.8) undergoing MIRT |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parkinsonian patients according to the UK Brain Bank criteria
Key exclusion criteria (4 listed)
- 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
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 | mildly impaired cognition, moderately-severely impaired cognition, normal cognition, pathological executive functions, patients with normal executive functions |
Primary outcome
Unified Parkinson's Disease Rating Scale
Time frame: 4 weeks
1 secondary outcome
Berg Balance Scale
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- 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.
Giuseppe Frazzitta, MD principal investigator
Department of Parkinson's Disease and Brain Injury Rehabilitation, of the 'Moriggia-Pelascini' Hospital - Gravedona ed Uniti (CO, Italy)
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's 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 4 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: finished, as of the sponsor's last update on 25 Mar 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's Disease Rating Scale (time frame: 4 weeks). 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 25 Mar 2016.