An interventional study of Bilateral robotic treatment for the upper limbs and Standard physiotherapy in Stroke, sponsored by University of Pisa. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-28.
Sponsored by University of Pisa · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to evaluate how manual dominance influences the effectiveness of bilateral robotic treatment in right-handed patients with chronic stroke.
Researchers will compare the outcome of a bilateral robotic treatment for the upper limbs in left vs right hemisphere lesions following stroke.
Participants will:
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 60 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →University of Pisa is the lead sponsor of 113 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The stroke patients with left hemisphere lesion will be performing the bilateral robotic treatment with the exoskeleton ALEx-RS followed by a standard manual treatment
Device: Bilateral robotic treatment for the upper limbs · Behavioral: Standard physiotherapy
The stroke patients with right hemisphere lesion will be performing the bilateral robotic treatment with the exoskeleton ALEx-RS followed by a standard manual treatment
Device: Bilateral robotic treatment for the upper limbs · Behavioral: Standard physiotherapy
Patients will perform a specific sequence of exercises with the exoskeleton for the upper limbs ALEx-RS, including passive and active-assisted movements, unilateral and bilateral reaching tasks with visual feedback, and symmetric and asymmetric bimanual coordination tasks.
After the robotic treatment, patients will undergo 20 minutes of conventional treatment consisting of passive and active-assisted mobilization with the help of a physiotherapist.
Changes in the Fugl-Meyer for the upper limb functional scale (UEFM)
The scale ranges from 0 to 66, with higher scores indicating better performance
Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
Changes in the Bimanual Activity Test scale (BAT)
The scale ranges from 0 to 100, with higher scores indicating better performance
Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
Changes in the modified Ashworth scale (MAS)
The scale ranges from 0 to 6, with lower scores indicating better performance
Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
Changes in the Stroke Impact Scale (SIS)
The scale ranges from 0 to 100, with higher scores indicating better performance
Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
Changes in the Visual Analogue Scale (VAS)
The scale ranges from 0 to 10, with higher scores indicating higher pain
Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
Changes in the Quick Dash scale
The scale ranges from 0 to 100, with higher scores indicating higher level of disability
Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
Changes in weighted Phase Lag Index (wPLI) cortico-cortical brain connectivity (EEG)
The investigators will be measuring variations in the weighted Phase Lag Index (wPLI)
Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
Changes in weighted Symbolic Mutual Information (wSMI) cortico-cortical brain connectivity (EEG)
The investigators will be measuring variations in the weighted Symbolic Mutual Information (wSMI)
Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
Changes in muscular synergies (EMG)
The investigators wil be measuring changes in muscle synergy patterns using the non-negative matrix factorization (NMF) algorithm
Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
Changes in kinematic movement smoothness (SPARC)
The investigators will measure changes in movement smoothness using the SPARC parameter
Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
No study locations are listed for this record.
Plan to share: Yes — all IPD that underlie results in a publication
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Dec 2026, 5 months later.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 5 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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