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NCT Number: NCT07259876

Efficacy of a Bilateral Robotic Treatment in Chronic Patients

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bilateral robotic treatment for the upper limbs

Device

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 Physiotherapy

Behavioral

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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)

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Collaborators

  • Azienda Ospedaliero, Universitaria Pisana
  • Fondazione Don Carlo Gnocchi ETS
  • Ospedale Policlinico San Martino
  • Villa Beretta Rehabilitation Center

Registry information

Official study title

Efficacy and Neurophysiological Correlates of a Bilateral Robotic Treatment for the Upper Limbs in Patients With Chronic Stroke Outcomes

Acronym: BUILT

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 2, 2025
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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