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Wearable robot arm and smart bracelet aim to boost movement in stroke and Parkinson's

NCT ID NCT07637123

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • IRCCS San Raffaele Cassino

    Cassino, FR, 03043, Italy

  • IRCCS San Raffaele Roma

    Roma, RM, 00163, Italy

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