Parkinson DiseaseIMOOVE-PDNCT04568447
Pilot Study on the Effects of IMOOVE in Parkinson's Disease Patients
A study testing IMOOVE in people with Parkinson Disease, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
Parkinson's Disease (PD) is one of the most frequent causes of motor dysfunction in aging. It is therefore important to use rehabilitative therapeutic approaches that may prevent the development of motor complications when possible. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- IMOOVE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jan 2019to 22 Mar 2021
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Parkinson's Disease (diagnosed according to UK Brain Bank Criteria);
- Age: 40-80
- Medical treatment for Parkinson's Disease must be stable for at least two weeks prior to inclusion, and during the study. During the study, the dosage of anti-parkinsonian drug treatment should not change, if it is not deemed necessary by the investigator.-
Who cannot join
- All the usual contraindications associated with physical medicine, rehabilitation and sport
Trial locations and contacts
1 site in 1 country.
About this study
Parkinson's Disease (PD) is one of the most frequent causes of motor dysfunction in aging.
It is therefore important to use rehabilitative therapeutic approaches that may prevent the development of motor complications when possible.
Imoove® is a device dedicated to rehabilitation and fitness and has the capacity to increase muscle tenfold.
The project is focused on quantifying the efficacy of IMOOVE® as a treatment method for improving joint mobility, posture and autonomy in PD.
Read the detailed description
The pathogenesis of PD-related postural abnormalities is probably multifactorial as well as widely indefinite, and this could compromise treatment choices and efficacy. In addition to dystonia and rigidity, proprioceptive and sensorimotor disintegration as well as peripheral degenerative processes (myopathy, skeletal and soft tissue changes) have been proposed as causative factors of abnormal trunk postures.
When the body is educated in the Elispheric® movement it relearns the original vertebral motion, and postural control necessary for any action by the body, the professional can then perform effective vertebral reeducation.
The Elispheric® movements are created by a motorised plate. This unique technology impulses the body through a centrifugal force in three planes. This force trains the body in its natural spirals.
The performance result is based on the fact that Imoove restores the all freedom of movement, strength, precision and it works on the basic skeletal posture.
It is an exploratory study, in order to verify if the project is adequate, to establish its feasibility and to obtain information that allows to determine the size of the sample of the definitive study, 30 consecutive PD outpatients will be recruited for the IMOOVE® treatment.
- Conditions
- Parkinson Disease
- Being tested
- IMOOVE
- Keywords
- parkinson disease, Imoove, Elispheric movement
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMOOVEDevice
Imoove® is a device dedicated to rehabilitation and fitness and has the capacity to increase muscle tenfold.
| Study group | Role | What they receive |
|---|---|---|
| IMOOVE | Experimental | Patients will undergo IMOOVE® treatment for 6 weeks, two times per week for a total of 12 treatments. Receives: Device: IMOOVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDS-UPDRS score
Change in the motor symptoms evaluated with the Movement Disorder Society Unified Parkinson's Disease Rating scale (MDS-UPDRS).
Each parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The maximum total UPDRS score is 199, indicating the worst possible disability from PD.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
EURO QOL-5D (EQ-5D)
Positive change in the quality of life score between 0-100 (from worst to better quality of life)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2020
- Study start9 Jan 2019
- Primary completion22 Mar 2021
- Study completion22 Mar 2021
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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- fabrizio stocchi, md phd, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04568447
- Sponsor's protocol ID
- RP 36/18
- Acronym
- IMOOVE-PD
- Status last verified
- Oct 2022
- First submitted
- 23 Sep 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after the end of study
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effects of IMOOVE in Parkinson's Disease Patients
- ClinicalTrials.gov ID
- NCT04568447
- Acronym / sponsor ID
- IMOOVE-PD / RP 36/18
- Conditions
- Parkinson Disease
- Keywords
- parkinson disease, Imoove, Elispheric movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 29 Sep 2020 (actual)
- 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.
Parkinson's Disease (PD) is one of the most frequent causes of motor dysfunction in aging.
It is therefore important to use rehabilitative therapeutic approaches that may prevent the development of motor complications when possible.
Imoove® is a device dedicated to rehabilitation and fitness and has the capacity to increase muscle tenfold.
The project is focused on quantifying the efficacy of IMOOVE® as a treatment method for improving joint mobility, posture and autonomy in PD.
Detailed description
The pathogenesis of PD-related postural abnormalities is probably multifactorial as well as widely indefinite, and this could compromise treatment choices and efficacy. In addition to dystonia and rigidity, proprioceptive and sensorimotor disintegration as well as peripheral degenerative processes (myopathy, skeletal and soft tissue changes) have been proposed as causative factors of abnormal trunk postures.
When the body is educated in the Elispheric® movement it relearns the original vertebral motion, and postural control necessary for any action by the body, the professional can then perform effective vertebral reeducation.
The Elispheric® movements are created by a motorised plate. This unique technology impulses the body through a centrifugal force in three planes. This force trains the body in its natural spirals.
The performance result is based on the fact that Imoove restores the all freedom of movement, strength, precision and it works on the basic skeletal posture.
It is an exploratory study, in order to verify if the project is adequate, to establish its feasibility and to obtain information that allows to determine the size of the sample of the definitive study, 30 consecutive PD outpatients will be recruited for the IMOOVE® treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMOOVE | Experimental | Device: IMOOVEPatients will undergo IMOOVE® treatment for 6 weeks, two times per week for a total of 12 treatments. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Parkinson's Disease (diagnosed according to UK Brain Bank Criteria);
- Age: 40-80
- Medical treatment for Parkinson's Disease must be stable for at least two weeks prior to inclusion, and during the study. During the study, the dosage of anti-parkinsonian drug treatment should not change, if it is not deemed necessary by the investigator.-
Key exclusion criteria (1 listed)
- All the usual contraindications associated with physical medicine, rehabilitation and sport
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 |
|---|---|---|
| IMOOVEImoove® is a device dedicated to rehabilitation and fitness and has the capacity to increase muscle tenfold. | Device | IMOOVE |
Primary outcome
MDS-UPDRS score
Time frame: through study completion, an average of 1 year
Change in the motor symptoms evaluated with the Movement Disorder Society Unified Parkinson's Disease Rating scale (MDS-UPDRS). Each parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The maximum total UPDRS score is 199, indicating the worst possible disability from PD.
1 secondary outcome
EURO QOL-5D (EQ-5D)
Time frame: through study completion, an average of 1 year
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 10 Apr 2024.
- Individual participant dataSharing planned: Yes. after the end of study
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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.
fabrizio stocchi, md phd principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMOOVE in people with Parkinson Disease, run by IRCCS San Raffaele Roma 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 3 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: finished, as of the sponsor's last update on 10 Apr 2024. 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?
MDS-UPDRS score (time frame: through study completion, an average of 1 year). 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 10 Apr 2024.