Parkinson DiseaseP-AMANCT04045080
Hand Rehab Using AMADEO in PD Patients
A study testing AMADEO, Training and OT Training in people with Parkinson Disease, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
Hand movements are particularly impaired in Parkinson's Disease (PD) patients contributing to functional disability and difficulties in activities of daily living. AMADEO®. is an end-effector system enables intensive training with frequently repeated gripping movements. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- AMADEO, Training and OT Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 1 Jun 2024
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Idiopathic PD diagnosed according to the Gelb's criteria;
- Hoehn-Yahr stage 1- 3
- "On" state
- MMSE score ≥ 24
- Willing and able to give written informed consent;
- Willing and able to comply with the study procedures.
Who cannot join
- A specific kind of fluctuation: Sudden on-off fluctuations
- History sign or symptoms suggesting the diagnosis of atypical or secondary Parkinsonisms;
- History of stereotaxic brain surgery for PD;
- Mini-mental examination (MMSE) score less than 24 at screening;
- Changes in Levodopa (DA) dose in any time within 4 week prior to baseline;
- Changes in Dopamine Agonists (DA) in any formulation in any time within 4 week prior to baseline;
- Presence of severe dyskinesia prior to baseline;
- Any other medical or psychiatric condition that may compromise the patient's participation in this study;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Centro Neurolesi "Bonino-Pulejo"
Messina, 98124
Rossella Ciurleo, rossella.ciurleo@irccsme.it
About this study
Official title: The Use of AMADEO in Hand Rehabilitation in Patients With Parkinson Disease
Hand movements are particularly impaired in Parkinson's Disease (PD) patients contributing to functional disability and difficulties in activities of daily living. AMADEO®. is an end-effector system enables intensive training with frequently repeated gripping movements. It offers the possibility to select from between passive, assistive and active modes using exercise of finger strength, finger movement, movement control and a selective activation of the fingers.Aim of this study is to evaluate the efficacy of the end-effector finger system, AMADEO®, on hand-finger movements in PD patients evaluating the improvement on finger tapping and agility of hand movement item scores on the MDS-UPDRS, variation on the active finger strengths and the active and passive Range of Motion (ROM); variation on Electromyographic (EMG)-parameters.
- Conditions
- Parkinson Disease
- Being tested
- AMADEO, Training, OT Training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMADEODevice
AMADEO® is an end-effector system enables intensive training with frequently repeated gripping movements. It offers the possibility to select from between passive, assistive and active modes using exercise of finger strength, finger movement, movement control and a selective activation of the fingers.
Moreover, even without muscular strength, active work can be done using EMG-based training. The Continuous Passive Motion (CPM Plus) therapy facilitates the implementation of automatic movement sequences even when the patient is unable to complete the entire range of motion on their own. It may be used in all phases of finger-hand rehabilitation and can be adapted to the needs of every patient.
In patients with PD, it will be useful in improving bradykinesia and potentially distal hypostenia.
TrainingOther
training
OT TrainingOther
training
| Study group | Role | What they receive |
|---|---|---|
| AMADEO Training | Experimental | Twenty PD patients with hand bradykinesia will be treated with the AMADEO® system. They will undergo 15 training sessions, 5 a week for 3 weeks, each session lasting about 60 minutes. During each session, both the hands will be treated using the endeffector in its active and active-assisted modality. Receives: Device: AMADEO; Other: Training |
| OT training | Active comparator | Twenty control subjects (PD patients) will be treated with traditional rehabilitation focused on fine hand-finger movement skills. The patients in this group will undergo the same amount of treatment.
Both the groups will be trained with conventional physiotherapy concerning postural, balance and gait. Receives: Other: OT Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nine hole peg test
9HPT is used to measure finger dexterity in patients with various neurological diagnoses
Measured: 1 month
Secondary outcomes (1)
Bipolar surface electromyography
EMG will be recorded from the first dorsal interossieous (FDI) and extensor digitorum communis (EDC) muscles.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start1 Sep 2019
- Primary completion1 Dec 2019
- Study completion1 Jun 2024 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rocco Salvatore Calabrò, IRCCS Centro Neurolesi Bonino Pulejo
- Investigators
- Rocco S Calabrò, Study chair, IRCCS Centro Neurolesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045080
- Sponsor's protocol ID
- 41/19
- Acronym
- P-AMA
- Status last verified
- Mar 2024
- First submitted
- 2 Aug 2019
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of AMADEO in Hand Rehabilitation in Patients With Parkinson Disease
- ClinicalTrials.gov ID
- NCT04045080
- Acronym / sponsor ID
- P-AMA / 41/19
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 5 Aug 2019 (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.
Hand movements are particularly impaired in Parkinson's Disease (PD) patients contributing to functional disability and difficulties in activities of daily living. AMADEO®. is an end-effector system enables intensive training with frequently repeated gripping movements. It offers the possibility to select from between passive, assistive and active modes using exercise of finger strength, finger movement, movement control and a selective activation of the fingers.Aim of this study is to evaluate the efficacy of the end-effector finger system, AMADEO®, on hand-finger movements in PD patients evaluating the improvement on finger tapping and agility of hand movement item scores on the MDS-UPDRS, variation on the active finger strengths and the active and passive Range of Motion (ROM); variation on Electromyographic (EMG)-parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMADEO Training | Experimental | Device: AMADEO, Other: TrainingTwenty PD patients with hand bradykinesia will be treated with the AMADEO® system. They will undergo 15 training sessions, 5 a week for 3 weeks, each session lasting about 60 minutes. During each session, both the hands will be treated using the endeffector in its active and active-assisted modality. |
| OT training | Active comparator | Other: OT TrainingTwenty control subjects (PD patients) will be treated with traditional rehabilitation focused on fine hand-finger movement skills. The patients in this group will undergo the same amount of treatment. Both the groups will be trained with conventional physiotherapy concerning postural, balance and gait. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Idiopathic PD diagnosed according to the Gelb's criteria;
- Hoehn-Yahr stage 1- 3
- "On" state
- MMSE score ≥ 24
- Willing and able to give written informed consent;
Key exclusion criteria (8 listed)
- A specific kind of fluctuation: Sudden on-off fluctuations
- History sign or symptoms suggesting the diagnosis of atypical or secondary Parkinsonisms;
- History of stereotaxic brain surgery for PD;
- Mini-mental examination (MMSE) score less than 24 at screening;
- Changes in Levodopa (DA) dose in any time within 4 week prior to baseline;
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 |
|---|---|---|
| AMADEOAMADEO® is an end-effector system enables intensive training with frequently repeated gripping movements. It offers the possibility to select from between passive, assistive and active modes using exercise of finger strength, finger movement, movement control and a selective activation of the fingers. Moreover, even without muscular strength, active work can be done using EMG-based training. The Continuous Passive Motion (CPM Plus) therapy facilitates the implementation of automatic movement sequences even when the patient is unable to complete the entire range of motion on their own. It may be used in all phases of finger-hand rehabilitation and can be adapted to the needs of every patient. In patients with PD, it will be useful in improving bradykinesia and potentially distal hypostenia. | Device | AMADEO Training |
| Trainingtraining | Other | AMADEO Training |
| OT Trainingtraining | Other | OT training |
Primary outcome
Nine hole peg test
Time frame: 1 month
9HPT is used to measure finger dexterity in patients with various neurological diagnoses
1 secondary outcome
Bipolar surface electromyography
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Recruiting
Investigating Basal Ganglia-Cortical Physiology During Sleep and Its Modulation by Adaptive Deep Brain Stimulation in Parkinson Disease
Parkinson's Disease (PD)
Active, not recruitingPhase 2
A Study to Evaluate Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Parkinson's Disease
Parkinson&Amp;#39;s Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Not yet recruiting
Cognitive-Motor Training for Gait Adaptability in Parkinson Disease
Parkinson Disease
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.
Rocco S Calabrò study chair
IRCCS Centro Neurolesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMADEO, Training and OT Training in people with Parkinson Disease, 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 6 inclusion and 8 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 19 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rocco S Calabrò (+3909060128166, salbro77@tiscali.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine hole peg test (time frame: 1 month). 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 19 Mar 2024.