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Robotic arm training shows promise for stroke patients

NCT ID NCT04697368

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
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 Results may not be published yet.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)

Expanded access
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

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using a robotic exoskeleton for arm exercises helps people who had a stroke recover arm function better than standard therapy. About 70 adults with moderate to severe arm weakness within 90 days of their first stroke will participate. The goal is to see if robot-assisted rehab leads to greater improvement in arm movement and muscle control.

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 70 people

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

Started

Dec 2020

Expected to finish

Dec 2025

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 to 85 years

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 between 18 and 85 years; * first stroke with neurological outcomes affecting the upper limb; * patients with severe or moderate hemiparesis (FM-UL≤44), stratified according to severe (FM-UL ≤ 22) or moderate (22 \<FM-UL ≤ 44) motor deficit; * patients in the sub-acute phase within 90 days of the acute event, stratified by the distance from the acute event (OAI≤30; OAI\> 30); * Modified Ashworth Scale (MAS) of the main components (shoulder, elbow, and wrist) of the upper limb \<3; * sufficient cognitive and linguistic level to understand the instructions and provide consent; * signed informed consent. Exclusion Criteria: * unstable general clinical conditions; * severe visual impairment; * inability to maintain the sitting position; * mild motor deficit of the arm (FM-UL\> 44) at baseline; * recent botox injection in the upper limb or planned botox injection during the study period, including the follow-up; * inability to don the orthosis on the impaired upper limb; * bone instability in relevant areas of the upper extremity (unconsolidated fractures, fractures due to osteoporosis); * fixed contractures involving the impaired upper limb (e.g. frozen shoulder); * shoulder instability; * severe pain syndromes caused or intensified by rehabilitation with Armeo Power; * patients who need isolation for infectious diseases ; * epileptic disorder with frequent attacks that carry the risk of having a seizure during rehabilitation with Armeo Power; * history of physical or neurological conditions that interfere with study procedures or assessment of motor function; * interruption of treatment for 1 week, or 5 consecutive sessions; * participation in other innovative treatment protocols for the upper limb rehabilitation (e.g. robotics, virtual reality, AOT ... etc).

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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.

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria Ospedali Riuniti

    Foggia, Italy

  • Azienda Ospedaliero-Universitaria di Ferrara

    Ferrara, Italy

  • Fondazione "Gli Angeli di Padre Pio"

    San Giovanni Rotondo, Italy

  • IRCCS Centro Neurolesi Bonino Pulejo

    Messina, Italy

  • IRCCS San Raffaele Pisana

    Roma, 00163, Italy

  • IRCCS fondazione Santa Lucia

    Rome, Italy

  • Villa Bellombra

    Bologna, Italy

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