Efficacy of a Bilateral Robotic Treatment in Chronic Patients (BUILT)

April 27, 2026 updated by: Carmelo Chisari, University of Pisa

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Left hemisphere lesion group
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
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.
Behavioral: Standard physiotherapy
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.
Experimental: Right hemisphere lesion group
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
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.
Behavioral: Standard physiotherapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
The scale ranges from 0 to 100, with higher scores indicating better performance
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
The scale ranges from 0 to 6, with lower scores indicating better performance
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
The scale ranges from 0 to 100, with higher scores indicating better performance
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
The scale ranges from 0 to 10, with higher scores indicating higher pain
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
The scale ranges from 0 to 100, with higher scores indicating higher level of disability
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
The investigators will be measuring variations in the weighted Phase Lag Index (wPLI)
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
The investigators will be measuring variations in the weighted Symbolic Mutual Information (wSMI)
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
The investigators wil be measuring changes in muscle synergy patterns using the non-negative matrix factorization (NMF) algorithm
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
The investigators will measure changes in movement smoothness using the SPARC parameter
From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pisa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Azienda Ospedaliero, Universitaria Pisana
Fondazione Don Carlo Gnocchi Onlus
Ospedale Policlinico San Martino
Villa Beretta Rehabilitation Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0017901/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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