StrokeBUILTNCT07259876
Efficacy of a Bilateral Robotic Treatment in Chronic Patients
A study testing Bilateral robotic treatment for the upper limbs and Standard physiotherapy in people with Stroke, run by University of Pisa.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Bilateral robotic treatment for the upper limbs and Standard physiotherapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged between 18 and 80 years, of either sex
- Subjects able to understand and provide, or have provided on their behalf, informed consent
- History of a single unilateral ischemic or hemorrhagic cerebrovascular event in the chronic phase (> 6 months)
- Subjects with mild to moderate functional impairment of the right or left upper limb (ability to perform antigravity active movements)
Who cannot join
- Subjects with cognitive deficits that impair understanding of the required tasks (MMSE score corrected for age and education < 24/30)
- Subjects with severe visual deficits
- Subjects with upper limb spasticity preventing the use of robotic devices (spasticity measured using the Modified Ashworth Scale > 3)
- Inability or unwillingness to provide informed consent
- Left-handed subjects
About this study
Official title: Efficacy and Neurophysiological Correlates of a Bilateral Robotic Treatment for the Upper Limbs in Patients With Chronic Stroke Outcomes
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:
- perform a bilateral robotic treatment for the upper limb (15 sessions in three weeks) followed by 20-minutes standard manual rehabilitative sessions
- be evaluated before and after treatment with clinical scales, resting- state EEG and kinematic measurements
- Conditions
- Stroke
- Being tested
- Bilateral robotic treatment for the upper limbs, Standard physiotherapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral robotic treatment for the upper limbsDevice
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.
Standard physiotherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Left hemisphere lesion group | Experimental | 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 Receives: Device: Bilateral robotic treatment for the upper limbs; Behavioral: Standard physiotherapy |
| Right hemisphere lesion group | Experimental | 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 Receives: Device: Bilateral robotic treatment for the upper limbs; Behavioral: Standard physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
Secondary outcomes (9)
Changes in the Bimanual Activity Test scale (BAT)
The scale ranges from 0 to 100, with higher scores indicating better performance
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study startJul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana, Villa Beretta Rehabilitation Center, Fondazione Don Carlo Gnocchi ETS, Ospedale Policlinico San Martino
- Responsible party
- Principal investigator, Carmelo Chisari, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259876
- Sponsor's protocol ID
- 0017901/2025
- Acronym
- BUILT
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2025
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Neurophysiological Correlates of a Bilateral Robotic Treatment for the Upper Limbs in Patients With Chronic Stroke Outcomes
- ClinicalTrials.gov ID
- NCT07259876
- Acronym / sponsor ID
- BUILT / 0017901/2025
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero, Universitaria Pisana, Villa Beretta Rehabilitation Center, Fondazione Don Carlo Gnocchi ETS, Ospedale Policlinico San Martino
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- perform a bilateral robotic treatment for the upper limb (15 sessions in three weeks) followed by 20-minutes standard manual rehabilitative sessions
- be evaluated before and after treatment with clinical scales, resting- state EEG and kinematic measurements
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left hemisphere lesion group | Experimental | Device: Bilateral robotic treatment for the upper limbs, Behavioral: Standard physiotherapyThe stroke patients with left hemisphere lesion will be performing the bilateral robotic treatment with the exoskeleton ALEx-RS followed by a standard manual treatment |
| Right hemisphere lesion group | Experimental | Device: Bilateral robotic treatment for the upper limbs, Behavioral: Standard physiotherapyThe stroke patients with right hemisphere lesion will be performing the bilateral robotic treatment with the exoskeleton ALEx-RS followed by a standard manual treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects aged between 18 and 80 years, of either sex
- Subjects able to understand and provide, or have provided on their behalf, informed consent
- History of a single unilateral ischemic or hemorrhagic cerebrovascular event in the chronic phase (> 6 months)
- Subjects with mild to moderate functional impairment of the right or left upper limb (ability to perform antigravity active movements)
Key exclusion criteria (5 listed)
- Subjects with cognitive deficits that impair understanding of the required tasks (MMSE score corrected for age and education < 24/30)
- Subjects with severe visual deficits
- Subjects with upper limb spasticity preventing the use of robotic devices (spasticity measured using the Modified Ashworth Scale > 3)
- Inability or unwillingness to provide informed consent
- Left-handed subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral robotic treatment for the upper limbsPatients 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. | Device | Left hemisphere lesion group, Right hemisphere lesion group |
| Standard physiotherapyAfter the robotic treatment, patients will undergo 20 minutes of conventional treatment consisting of passive and active-assisted mobilization with the help of a physiotherapist. | Behavioural | Left hemisphere lesion group, Right hemisphere lesion group |
Primary outcome
Changes in the Fugl-Meyer for the upper limb functional scale (UEFM)
Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
The scale ranges from 0 to 66, with higher scores indicating better performance
9 secondary outcomes
Changes in the Bimanual Activity Test scale (BAT)
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)
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)
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)
Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
Changes in the Quick Dash scale
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)
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)
Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
Changes in muscular synergies (EMG)
Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
Changes in kinematic movement smoothness (SPARC)
Time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral robotic treatment for the upper limbs and Standard physiotherapy in people with Stroke, run by University of Pisa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Fugl-Meyer for the upper limb functional scale (UEFM) (time frame: From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.