Efficacy of a Bilateral Robotic Treatment in Chronic Patients

NCT ID: NCT07259876

Last Updated: 2025-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Bilateral robotic treatment for the upper limbs

Intervention Type 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

Intervention Type 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.

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

Group Type EXPERIMENTAL

Bilateral robotic treatment for the upper limbs

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero, Universitaria Pisana

OTHER

Sponsor Role collaborator

Centro Riabilitativo Villa Beretta

UNKNOWN

Sponsor Role collaborator

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role collaborator

Ospedale Policlinico San Martino

OTHER

Sponsor Role collaborator

University of Pisa

OTHER

Sponsor Role lead

Responsible Party

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Carmelo Chisari

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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0017901/2025

Identifier Type: -

Identifier Source: org_study_id

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