Efficacy of a Bilateral Robotic Treatment in Chronic Patients

NCT07259876 | Not Yet Recruiting

• 1 other identifier: 0017901/2025
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0

• Changes in the modified Ashworth scale (MAS)

  From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0

• Changes in the Stroke Impact Scale (SIS)

  From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0

• Changes in the Visual Analogue Scale (VAS)

  From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0

• Changes in the Quick Dash scale

  From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0

Study Arms (2)

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

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

Device: Bilateral robotic treatment for the upper limbs; Behavioral: Standard physiotherapy

Interventions

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.

Left hemisphere lesion group; Right hemisphere lesion group

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.

Left hemisphere lesion group; Right hemisphere lesion group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pisa: lead
• Azienda Ospedaliero, Universitaria Pisana: collaborator
• Villa Beretta Rehabilitation Center: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• Ospedale Policlinico San Martino: collaborator

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 2, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share