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

University of Pisa

Status: Not yet enrolling

Conditions: Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07259876

0017901/2025

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Left hemisphere lesion group

Experimental group

Description:

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

Treatment:

Device: Bilateral robotic treatment for the upper limbs

Behavioral: Standard physiotherapy

Right hemisphere lesion group

Experimental group

Description:

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

Treatment:

Device: Bilateral robotic treatment for the upper limbs

Behavioral: Standard physiotherapy