Parkinson DiseaseIRMANCT05802498
Rehabilitation in Parkinson Disease Cyclone in Life
A study testing IRMA in people with Parkinson Disease and Physical Disability, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
Comparison of two rehabilitation protocols in patients with Parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve: Improved joint function and gait pattern Reduction of the risk of falling or reduction of… Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Parkinson Disease, Physical Disability
- What is being tested?
- IRMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jul 2020to 20 Jan 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hoehn \& Yahr between 2.0 and 3.0;
- No need for a walking aid;
- Mini-Mental State Examination (MMSE) score >24;
- Effective dopaminergic pharmacological control;
- Absence of other relevant neurological comorbidities;
- Absence of postural deformities (and/or Pisa syndrome);
- Absence of severe cardiological pathologies (exertional angina, severe decompensation).
- Ability to travel to the rehabilitation treatment site independently or with support
Who cannot join
- presence of Deep Brain Stimulation (DBS);
- presence of severe heart and/or lung disease;
- presence of therapeutic regimen in the definition phase;
- impaired joint and/or motor function to follow a proposed rehabilitation treatment programme
- contraindications to performing MRI scans
- undergoing rehabilitation therapy in the 3 months preceding enrolment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IR3MA Parkinson Cyclone in Life: Innovation, R3 Rehabilitation - Resonance - RTD Fluxgate Sensor, Multidisciplinary Approach
Comparison of two rehabilitation protocols in patients with Parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve:
- Improved joint function and gait pattern
- Reduction of the risk of falling or reduction of energy expenditure during physiological gait
Evaluation of the increase in maximal effort tolerance
- Improved cognitive performances
Evaluation of the impact on the quality of life of the patient and family members
Identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.
Read the detailed description
rehabilitation protocols in patients with Parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve:
Improved joint function and gait pattern Reduction of the risk of falling or reduction of energy expenditure during physiological gait Evaluation of the increase in maximal effort tolerance
- Improved cognitive performances
Evaluation of the impact on the quality of life of the patient and family members
Identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.
- Conditions
- Parkinson Disease, Physical Disability
- Being tested
- IRMA
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRMADevice
For patients in an advanced state of illness, advanced neuromotor rehabilitation treatment included 1) robot therapies, 2) specific water courses (e.g. walking pools, hydrokinesiotherapy pools, etc.), 3) advanced cognitive treatments (e.g. virtual reality courses); 4) augmentative immersive therapy in a virtual environment; 5) courses also dedicated to social reintegration and inclusive activities (theatre-therapy, art-therapy, dance-therapy, agro-therapy, etc.).
| Study group | Role | What they receive |
|---|---|---|
| control GROUP | No intervention | This group will perform 8 continuous weeks of treatment, 5 days a week, for a total of 180 minutes, including muscle stretching, joint range increase with passive and active assisted mobilization sessions of the scapulohumeral and pelvic girdles. Motor coordination exercises. Postural exercises with exercises for trunk control in sitting and standing positions with feedback and feed-forward techniques. gait training; gait training; proprioceptive exercises and exercises to maintain static and dynamic balance in monopodalica; strengthening of trunk muscles; postural exercises, muscle relaxation/stretching, release of the tracks; re-education in postural passages and transfers with fall prevention strategies. |
| irma group | Experimental | This group will perform 8 continuous weeks of treatment, 5 days a week, for a total of 180 minutes, including muscle stretching, increasing joint range with assisted passive and active mobilisation sessions of the scapulohumeral and pelvic girdles. Motor coordination exercises. Postural exercises with exercises for trunk control in sitting and standing with feedback and feed-forward technique. Gait training; gait training; proprioceptive exercises and static and dynamic balance maintenance in monopodalics; trunk muscle strengthening; postural exercises, muscle relaxation/relaxation, caterpillar release; re-education in postural transitions and transfers with fall prevention strategies. Prior to neuromotor rehabilitation treatment, the subjects will undergo rehabilitation training using the NIRVANA augmentative reality system. Receives: Device: IRMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (BBS)
The Berg Balance Scale is a scale for assessing balance and the risk of falling
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start21 Jul 2020
- Primary completion1 Jan 2022
- Study completion20 Jan 2023
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802498
- Sponsor's protocol ID
- I.R.M.A.
- Acronym
- IRMA
- Status last verified
- Jul 2020
- First submitted
- 15 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IR3MA Parkinson Cyclone in Life: Innovation, R3 Rehabilitation - Resonance - RTD Fluxgate Sensor, Multidisciplinary Approach
- ClinicalTrials.gov ID
- NCT05802498
- Acronym / sponsor ID
- IRMA / I.R.M.A.
- Conditions
- Parkinson Disease, Physical Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 6 Apr 2023 (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.
Comparison of two rehabilitation protocols in patients with Parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve:
- Improved joint function and gait pattern
- Reduction of the risk of falling or reduction of energy expenditure during physiological gait
Evaluation of the increase in maximal effort tolerance
- Improved cognitive performances
Evaluation of the impact on the quality of life of the patient and family members
Identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.
Detailed description
rehabilitation protocols in patients with Parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve:
Improved joint function and gait pattern Reduction of the risk of falling or reduction of energy expenditure during physiological gait Evaluation of the increase in maximal effort tolerance
- Improved cognitive performances
Evaluation of the impact on the quality of life of the patient and family members
Identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control GROUP | No intervention | –This group will perform 8 continuous weeks of treatment, 5 days a week, for a total of 180 minutes, including muscle stretching, joint range increase with passive and active assisted mobilization sessions of the scapulohumeral and pelvic girdles. Motor coordination exercises. Postural exercises with exercises for trunk control in sitting and standing positions with feedback and feed-forward techniques. gait training; gait training; proprioceptive exercises and exercises to maintain static and dynamic balance in monopodalica; strengthening of trunk muscles; postural exercises, muscle relaxation/stretching, release of the tracks; re-education in postural passages and transfers with fall prevention strategies. |
| irma group | Experimental | Device: IRMAThis group will perform 8 continuous weeks of treatment, 5 days a week, for a total of 180 minutes, including muscle stretching, increasing joint range with assisted passive and active mobilisation sessions of the scapulohumeral and pelvic girdles. Motor coordination exercises. Postural exercises with exercises for trunk control in sitting and standing with feedback and feed-forward technique. Gait training; gait training; proprioceptive exercises and static and dynamic balance maintenance in monopodalics; trunk muscle strengthening; postural exercises, muscle relaxation/relaxation, caterpillar release; re-education in postural transitions and transfers with fall prevention strategies. Prior to neuromotor rehabilitation treatment, the subjects will undergo rehabilitation training using the NIRVANA augmentative reality system. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hoehn \& Yahr between 2.0 and 3.0;
- No need for a walking aid;
- Mini-Mental State Examination (MMSE) score >24;
- Effective dopaminergic pharmacological control;
- Absence of other relevant neurological comorbidities;
Key exclusion criteria (6 listed)
- presence of Deep Brain Stimulation (DBS);
- presence of severe heart and/or lung disease;
- presence of therapeutic regimen in the definition phase;
- impaired joint and/or motor function to follow a proposed rehabilitation treatment programme
- contraindications to performing MRI scans
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 |
|---|---|---|
| IRMAFor patients in an advanced state of illness, advanced neuromotor rehabilitation treatment included 1) robot therapies, 2) specific water courses (e.g. walking pools, hydrokinesiotherapy pools, etc.), 3) advanced cognitive treatments (e.g. virtual reality courses); 4) augmentative immersive therapy in a virtual environment; 5) courses also dedicated to social reintegration and inclusive activities (theatre-therapy, art-therapy, dance-therapy, agro-therapy, etc.). | Device | irma group |
Primary outcome
Berg Balance Scale (BBS)
Time frame: 8 weeks
The Berg Balance Scale is a scale for assessing balance and the risk of falling
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 6 Apr 2023.
- Individual participant dataSharing planned: No. corresponding author
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRMA in people with Parkinson Disease and Physical Disability, run by IRCCS Centro Neurolesi Bonino Pulejo 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 8 inclusion and 6 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 6 Apr 2023. 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?
Berg Balance Scale (BBS) (time frame: 8 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 6 Apr 2023.