NCT04697368Completed
The Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.
A Randomized Controlled Multicenter Study on the Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
Loss of arm function is a common and distressing consequence of stroke. Neurotechnology-aided rehabilitation could be a promising approach to accelerate the recovery of upper limb functional impairments. This multicentre randomized controlled trial is aimed at assessing the efficacy of robot-assisted upper limb rehabilitation in subjects with sub-acute stroke following a stroke, compared to the traditional upper limb rehabilitation.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 94 (actual)
- First submitted
- 30 Dec 2020
- Start date
- 28 Dec 2020
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- IRCCS San Raffaele Roma
- Diseases
- Stroke
- NCT number
- NCT04697368
What you commit to
- Study type: Interventional
- Participants enrolled: 94
- From 28 Dec 2020 to the primary completion date, 1 Mar 2025
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- unstable general clinical conditions;
- severe visual impairment;
- 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;
Other
- 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;
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Villa Bellombra Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Azienda Ospedaliero Universitaria di Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Ospedali Riuniti Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| IRCCS Centro Neurolesi Bonino Pulejo Coordinator of this site? Confirm its status | Messina | Italy | Unknown status |
| IRCCS San Raffaele Pisana Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| IRCCS Fondazione Santa Lucia Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
| Fondazione "Gli Angeli di Padre Pio" Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.