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New treatment option for Stroke
Official title Bilateral Robot-assisted Upper Extremity Rehabilitation on Motor Recovery in People With Subacute Stroke
ClinicalTrials.gov ID: NCT06906588
What this study is testing
- What it's testing
- 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.
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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;
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cassino, Italy, Italy
- Rome, Italy, Italy
- Sulmona, Italy, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cassino, Italy, Italy; Rome, Italy, Italy; Sulmona, Italy, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.