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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • 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

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
Intervention / Treatment
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

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

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

University of Pisa

Collaborators

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)

July 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 2, 2025

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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