Parkinson DiseaseNCT03893786
Robotic Rehabilitation of Upper Limb in PD
A study testing Robotic Rehabilitation in people with Parkinson Disease, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial summary
It has been shown that robot-assisted therapy may be considered an effective and reliable method for the delivery of highly repetitive training useful to boost neuroplasticity. Thus, an early, intensive, repetitive and task oriented training could be an ideal strategy to facilitate relearning of motor function and to… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Robotic Rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2019to 1 Apr 2020
- 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
- Idiopathic PD diagnosed according to the UK BRAIN BANK criteria
- Hoehn-Yahr stage 2- 3
- MMSE score ≥ 23
Who cannot join
- Severe Dyskinesia
- On-Off Motor fluctuations
- History of stereotaxic brain surgery for PD;
- Changes in dopamine therapy dose in any time within 3 months prior to baseline;
- Any other medical that may compromise the patient's participation in this study such as history of ostheoarthritis or neuropathies.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Neurolesi
Messina, Sicily, 98123
Rossella Ciurleo, PhD, +390906018159, rosella.ciurleo@irccsme.it
About this study
Official title: Upper Limb Rehabilitation Using Armeo Spring in Patients With Parkinson's Disease.
It has been shown that robot-assisted therapy may be considered an effective and reliable method for the delivery of highly repetitive training useful to boost neuroplasticity. Thus, an early, intensive, repetitive and task oriented training could be an ideal strategy to facilitate relearning of motor function and to improve motor function. The ARMEO-S® is a specific upper limb electromedical device mainly used to reduce spasticity and improve muscle force. To date robotic upper limb training has been applied only in patiebts with brain injury and spinal cord lesions.
Aim of the study is to evaluate the efficacy of ARMEO-S in improving upper limb agility in a sample of PD patients, as compared to traditional physiotherapy.
- Conditions
- Parkinson Disease
- Being tested
- Robotic 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.
Robotic RehabilitationDevice
Fifteen patients with Parkinson's Disease will perform ten 45-minute training sessions of the upper limb bilaterally with the Armeo®Spring, an electromedicad device aimed at improving force and coordination in neurologically affected patients.
The device was built to sustain the forearm during the upperlimb training and is equipped with a VR screen with which the patient may interact during the playful and motivating rehab.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Treatment | Experimental | Fifteen patients with Parkinson's Disease will perform ten 45-minutes training sessions of the upper limb using the Armeo®Spring applied bilaterally, an electromedical device aimed at improving force and coordination in neurologically affected patients.
The device was built to sustain the forearm during the upper limb training and it is equipped with a VR screen with which the patient may interact during the playful and motivating rehab. Receives: Device: Robotic Rehabilitation |
| Conventional Treatment | Active comparator | Fifteen patients with Parkinson's Disease will undergo ten 45-minutes training sessions of the upper limb with a traditional approach, performing the same excercises of the experimental group, i.e. flexo-extension of the wrist, prono-supination of the forearm, etcc. Receives: Device: Robotic Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS rating scale- Section III
To assess whether PD patients may got better results in the motor part of the UPDRS after the UL training
Measured: 2 months
Nine hole peg test
To evaluate if the patients will get better dexterity after the robotic training
Measured: 2 months
Secondary outcomes (1)
Upper Limb Fugl-Mayer
to verify whether PD patients may present with an increase in muscle strenght after the treatment.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Jul 2019
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2020 (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
- Investigator, Outcomes assessor
- Enrolment
- 30 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893786
- Sponsor's protocol ID
- 29/2018
- Status last verified
- Jul 2019
- First submitted
- 26 Mar 2019
- Last updated
- 1 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Limb Rehabilitation Using Armeo Spring in Patients With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT03893786
- Acronym / sponsor ID
- 29/2018
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 28 Mar 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.
It has been shown that robot-assisted therapy may be considered an effective and reliable method for the delivery of highly repetitive training useful to boost neuroplasticity. Thus, an early, intensive, repetitive and task oriented training could be an ideal strategy to facilitate relearning of motor function and to improve motor function. The ARMEO-S® is a specific upper limb electromedical device mainly used to reduce spasticity and improve muscle force. To date robotic upper limb training has been applied only in patiebts with brain injury and spinal cord lesions.
Aim of the study is to evaluate the efficacy of ARMEO-S in improving upper limb agility in a sample of PD patients, as compared to traditional physiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Treatment | Experimental | Device: Robotic RehabilitationFifteen patients with Parkinson's Disease will perform ten 45-minutes training sessions of the upper limb using the Armeo®Spring applied bilaterally, an electromedical device aimed at improving force and coordination in neurologically affected patients. The device was built to sustain the forearm during the upper limb training and it is equipped with a VR screen with which the patient may interact during the playful and motivating rehab. |
| Conventional Treatment | Active comparator | Device: Robotic RehabilitationFifteen patients with Parkinson's Disease will undergo ten 45-minutes training sessions of the upper limb with a traditional approach, performing the same excercises of the experimental group, i.e. flexo-extension of the wrist, prono-supination of the forearm, etcc. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic PD diagnosed according to the UK BRAIN BANK criteria
- Hoehn-Yahr stage 2- 3
- MMSE score ≥ 23
Key exclusion criteria (5 listed)
- Severe Dyskinesia
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 |
|---|---|---|
| Robotic RehabilitationFifteen patients with Parkinson's Disease will perform ten 45-minute training sessions of the upper limb bilaterally with the Armeo®Spring, an electromedicad device aimed at improving force and coordination in neurologically affected patients. The device was built to sustain the forearm during the upperlimb training and is equipped with a VR screen with which the patient may interact during the playful and motivating rehab. | Device | Conventional Treatment, Robotic Treatment |
Primary outcome
UPDRS rating scale- Section III
Time frame: 2 months
To assess whether PD patients may got better results in the motor part of the UPDRS after the UL training
Nine hole peg test
Time frame: 2 months
To evaluate if the patients will get better dexterity after the robotic training
1 secondary outcome
Upper Limb Fugl-Mayer
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Individual participant dataSharing planned: Undecided
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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 Robotic Rehabilitation 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 3 inclusion and 5 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 1 Aug 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UPDRS rating scale- Section III (time frame: 2 months). The study lists 2 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 1 Aug 2019.