Status:
RECRUITING
Bilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With Subacute Stroke
Lead Sponsor:
IRCCS San Raffaele Roma
Collaborating Sponsors:
Ministry of Health, Italy
Conditions:
Stroke
Sabacute Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 rehabilit...
Detailed Description
Cerebral stroke is one of the major causes of mortality and disability in the world. Upper limb disorders are evident up to 85% of stroke survivors and persist, even 6 months after the acute event, in...
Eligibility Criteria
Inclusion
- 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
- 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 complications or personality disorders;
- 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.
Key Trial Info
Start Date :
May 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06906588
Start Date
May 19 2024
End Date
December 31 2026
Last Update
April 4 2025
Active Locations (3)
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1
San Raffaele Cassino
Cassino, Italy, Italy, 03043
2
IRCCS San Raffaele Roma
Rome, Italy, Italy, 00166
3
San Raffaele Sulmona
Sulmona, Italy, Italy, 67039