Upper limb rehabilitation using exoskeletons for patients with subacute stroke

A Randomized Controlled Multicenter Study on the Efficacy of Upper Limb Rehabilitation With Exoskeleton in Patients With Subacute Stroke.

This study is testing whether using a robotic exoskeleton for upper limb rehabilitation can help people who have had a stroke recover better than traditional therapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: IRCCS San Raffaele Roma (Academic / other)
• Locations: 8 sites (Bergamo, BG and 7 other locations)
• Trial ID: NCT04697368 on ClinicalTrials.gov

What this trial studies

This multicentre randomized controlled trial aims to evaluate the effectiveness of robot-assisted upper limb rehabilitation compared to traditional rehabilitation methods in patients who have experienced a subacute stroke. The study focuses on individuals aged 18 to 85 with moderate to severe upper limb paresis, assessing improvements in motor function through repetitive task training facilitated by an exoskeleton. Participants will be stratified based on the severity of their motor deficits and the time elapsed since their stroke. The goal is to determine if this innovative approach can enhance recovery outcomes for stroke survivors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 who have experienced their first stroke and have moderate to severe upper limb paresis within 90 days of the event.

Not a fit: Patients with mild motor deficits, unstable clinical conditions, or severe visual impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve upper limb function and quality of life for stroke patients.

How similar studies have performed: Previous studies have shown promising results with robot-assisted rehabilitation approaches, indicating potential for success in this trial.

Eligibility criteria

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).

Where this trial is running

Bergamo, BG and 7 other locations

• HABILITA S.p.A — Bergamo, Bg, Italy (Not_yet_recruiting)
• Villa Bellombra — Bologna, Italy (Recruiting)
• Azienda Ospedaliero-Universitaria di Ferrara — Ferrara, Italy (Not_yet_recruiting)
• Azienda Ospedaliero Universitaria Ospedali Riuniti — Foggia, Italy (Not_yet_recruiting)
• IRCCS Centro Neurolesi Bonino Pulejo — Messina, Italy (Not_yet_recruiting)
• IRCCS San Raffaele Pisana — Roma, Italy (Recruiting)
• IRCCS fondazione Santa Lucia — Rome, Italy (Active_not_recruiting)
• Fondazione "Gli Angeli di Padre Pio" — San Giovanni Rotondo, Italy (Recruiting)

Study contacts

• Principal investigator: Marco Franceschini, Prof. — IRCCS San Raffaele Pisana
• Study coordinator: Sanaz Pournajaf, Dr.

Conditions Stroke; Upper Extremity Paresis; Subacute; upper limb; motor function; robot-assisted rehabilitation; Armeo Power; exoskeleton