NCT06906588Recruiting
Bilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With Subacute Stroke
Effects of Bilateral Upper Limb Robot-assisted Rehabilitation on Motor Recovery in Patients With Subacute Stroke: an Italian Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
The goal of this clinical trial is to study the clinical effects of a robotic rehabilitation treatment through a bilateral exoskeleton (Bilateral Robot-Assisted Therapy-BRAT) during standard rehabilitation, on motor recovery, compared to conventional arm re-education in people suffering from stroke in the subacute phase. The main question it aims to answer is what the effectiveness of Bilateral Robot-Assisted Therapy (BRAT) is in rehabilitating the upper limb in individuals with subacute stroke compared to conventional rehabilitation treatment in terms of motor function improvement as measured by the Fugl-Meyer Assessment - Upper Limb (FMA-UL), motor domain. Researchers will compare two groups (Experimental Group - EG and Control Group - CG) to see if the BRAT is more effective than conventional rehabilitation treatment in terms of motor recovery. Participants will be randomly assigned to one of the two treatment groups (EG or CG) and will be clinically and instrumentally evaluated at baseline (T0) and at the end of treatment (T1). EG, in addition to the standard rehabilitation treatment, will perform a 45-minute session of BRAT per day through the Arm Light Exoskeleton Hybrid (Alex RS - Wearable Robotics) robotic system. The CG, in addition to the standard routine rehabilitation treatment, will follow a conventional rehabilitation of the upper limbs without the use of technological devices. Finally, a telephone follow-up is scheduled three months after the end of the treatment.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 26 Mar 2025
- Start date
- 19 May 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- IRCCS San Raffaele Roma
- Diseases
- Stroke
- NCT number
- NCT06906588
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 19 May 2024 to the primary completion date, 31 Dec 2026
- 3 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;
- Bilateral pyramidal hemisyndrome severe visual impairment;
- Presence of neurological pathologies superimposed on the stroke event, psychiatric complications or personality disorders;
Other
- Recent injection of Botulinum Toxin to the affected upper limb or planned for the duration of the study;
- Interruption of treatment for 1 week or 5 consecutive sessions;
- Inability to adhere to the exercise program due to poor compliance;
- Presence of osteoarticular and neuromuscular pathologies that may compromise the motor skills of the upper limb;
- Participants who have not signed the informed consent to the study.
Who the study is looking for
- Both sexes;
- Age \>18 years;
- Unilateral hemipyramidal syndrome as demonstrated by a brain CT or MRI;
- Distance from acute event \< 6 months;
- Modified Ashworth Scale (MAS) of shoulder, elbow, and wrist \<3;
- Ability to understand and sign the informed consent for the study;
- Ability to perform the study procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| San Raffaele Cassino Coordinator of this site? Confirm its status | Cassino | Italy | Not yet recruiting |
| IRCCS San Raffaele Roma Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| San Raffaele Sulmona Coordinator of this site? Confirm its status | Sulmona | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.