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New treatment option for Stroke
Official title Robotic Rehabilitation of the Upper Limb in Subacute Stroke
ClinicalTrials.gov ID: NCT06839482
What this study is testing
- What it's testing
- This multicenter international randomized controlled trial (RCT) evaluates the effectiveness of the Gloreha Sinfonia® robotic exoskeleton for upper limb rehabilitation in individuals with subacute post-stroke paresis. The study aims to determine whether robotic-assisted therapy improves voluntary motor control and coordination more effectively than conventional rehabilitation, as measured by the Fugl-Meyer Assessment (FMA) for the upper limb (motor component).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Both sexes
- Age 18-90 years
- Paresis of the upper limb following a recent cerebrovascular event (subacute ischemic or hemorrhagic stroke)
- Moderate to mild muscle weakness in the thumb opponens, common finger flexors, and wrist flexors, assessed with complete joint movement in absence of...
- Time from acute event \<90 days
You likely can't join if
- Presence of other overlapping neurological disorders
- Presence of osteoarticular or neuromuscular disorders affecting upper limb mobility
- Severe psychiatric disorders
- Severe cognitive (MMSE ≤ 17) and/or language impairment compromising exercise comprehension
- Botulinum toxin injection in the affected upper limb within the last 60 days or planned during the study and follow-up period
- Open wounds, infections, or unprotected skin lesions on the upper limb
See the full eligibility criteria
- Both sexes
- Age 18-90 years
- Paresis of the upper limb following a recent cerebrovascular event (subacute ischemic or hemorrhagic stroke)
- Moderate to mild muscle weakness in the thumb opponens, common finger flexors, and wrist flexors, assessed with complete joint movement in absence of gravity, Medical Research Council Scale (MRC) ≥ 2
- Time from acute event \<90 days
- Ability to understand and sign the study informed consent
- Ability to perform study procedures.
- Presence of other overlapping neurological disorders
- Presence of osteoarticular or neuromuscular disorders affecting upper limb mobility
- Severe psychiatric disorders
- Severe cognitive (MMSE ≤ 17) and/or language impairment compromising exercise comprehension
- Botulinum toxin injection in the affected upper limb within the last 60 days or planned during the study and follow-up period
- Open wounds, infections, or unprotected skin lesions on the upper limb
- Severe spasticity of the upper limb (biceps and wrist and finger flexors) (MAS \> 3)
- Inability to adhere to the exercise program due to low compliance
- Participants who have not signed the informed consent for the study
The study team makes the final eligibility decision.
Where it's taking place
- Elkins Park, Pennsylvania, United States
- Kladruby, Czechia
- Lázně Bělohrad, Czechia
- Olomouc, Czechia
- Prague, Czechia
- Rome, Choose One..., Italy
- San Vito sullo Ionio, CZ, Italy
- Costa Masnaga, LC, Italy
- Fiorenzuola d'Arda, PC, Italy
- Passignano sul Trasimeno, Perugia, Italy
- Ummbertide, PG, Italy
- Rome, RM, Italy
- Bergamo, Italy
- Catanzaro, Italy
- Florence, Italy
- Foggia, Italy
- Messina, Italy
- Moscow, Russia
- Madrid, Spain
- Chiang Mai, Thailand
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Elkins Park, Pennsylvania, United States; Kladruby, Czechia; Lázně Bělohrad, Czechia; Olomouc, Czechia; Prague, Czechia; Rome, Choose One..., Italy and 14 more location(s). 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.