Wearable robot arm and smart bracelet aim to boost movement in stroke and Parkinson's
NCT ID NCT07637123
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study will test a comfortable, soft elbow brace that helps bend and straighten the arm, along with a vibrating forearm bracelet that gives touch cues. About 45 people with stroke or Parkinson's disease will try these devices during arm exercises. The goal is to see if the devices are easy to use, safe, and helpful for movement and daily tasks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 years or older. * Able to understand the study procedures and follow study instructions. * Signed informed consent obtained before participation. * Adequate cognitive function, defined as Mini-Mental State Examination score ≥24 or equivalent clinical assessment. * Upper-limb functional limitation compatible with participation in the study. * QuickDASH score between 20 and 70. * Arm and forearm dimensions compatible with safe and appropriate fitting of the wearable device. Additional inclusion criteria for stroke participants * Clinically confirmed diagnosis of ischemic or hemorrhagic stroke, documented by computed tomography or magnetic resonance imaging. * Upper-limb motor impairment involving the proximal upper limb, including shoulder and/or elbow functional limitation. * Modified Ashworth Scale score \<3 in the affected upper limb. * Residual upper-limb motor function compatible with the assigned device-assisted experimental tasks. * Fugl-Meyer Assessment Upper Extremity score ≥15. Additional inclusion criteria for Parkinson's disease participants * Clinically confirmed diagnosis of idiopathic Parkinson's disease. * Modified Hoehn and Yahr stage II or III. * Upper-limb motor impairment such as bradykinesia, rigidity, tremor, or reduced dexterity. * Unified Parkinson's Disease Rating Scale Part III upper-limb motor items compatible with mild-to-moderate impairment. * Assessment performed in the "on" medication state, within two hours after levodopa intake. Exclusion Criteria: * Severe cognitive impairment, defined as Mini-Mental State Examination score \<24, or any condition preventing comprehension of study procedures or instructions. * Unstable medical condition that could increase risk during participation, including uncontrolled cardiovascular disease, severe respiratory failure, active systemic infection, or recent major surgery. * Dermatological disease, open wounds, skin lesions, or skin hypersensitivity in the areas where the wearable devices would be applied. * Contraindications to use of the study devices, including implanted pacemaker, relevant metallic implants near the application area, or known allergy to device materials. * Severe spasticity of the affected upper limb that would prevent safe device use, defined as Modified Ashworth Scale score ≥3. * Severe upper-limb pain that could be worsened by active or passive movement. * Participation in another interventional clinical study involving upper-limb rehabilitation or motor rehabilitation within 30 days before enrollment. * Use of investigational drugs or investigational treatments within 30 days before study participation. * Confirmed or suspected pregnancy. * Any condition that, in the investigator's judgment, could interfere with study procedures, affect participant safety, or expose the participant to undue risk. * Refusal or inability to provide signed informed consent.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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IRCCS San Raffaele Cassino
Cassino, FR, 03043, Italy
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IRCCS San Raffaele Roma
Roma, RM, 00163, Italy
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