Bilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With S
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 phas
| Condition(s) | Stroke, Sabacute Stroke |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 conven |
| Who can participate | Inclusion Criteria: * 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. Exclusion Criteria: * Unstable general clinical conditions; * Bilateral pyramidal hemisyndrome severe visual impairment; * 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 neurological pathologies superimposed on the stroke event, psychiatric compl |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | IRCCS San Raffaele Roma |
| Locations | Cassino, Italy, Italy; Rome, Italy, Italy; Sulmona, Italy, Italy |
| Start date | 2024-05-19 |
| NCT ID | NCT06906588 |
| Official listing | https://clinicaltrials.gov/study/NCT06906588 |