Bilateral Robotic Rehabilitation in Chronic Stroke

NCT ID: NCT07145476

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-10
• Study Completion Date: 2022-09-10

Brief Summary

This study investigated the effectiveness and neurophysiological correlates of Bilateral Robot-Assisted Training (BRAT) in right-handed individuals with chronic unilateral stroke, focusing on how lesion side (dominant vs. non-dominant hemisphere) influences recovery. Twenty-four participants (>6 months post-stroke) completed a three-week BRAT program using the ALEx-RS robotic exoskeleton integrated with cognitively engaging serious games involving symmetric and asymmetric upper limb tasks.

Clinical outcomes (Fugl-Meyer Assessment, Bimanual Activity Test, Motricity Index) and kinematic measures (movement smoothness, movement duration) were assessed at baseline, post-treatment, and at two-month follow-up. Significant improvements (p < 0.05) in all outcomes were observed after training and maintained at follow-up.

Patients with left hemiparesis (non-dominant side affected) showed greater gains in movement smoothness and bimanual task quality, suggesting recovery of more physiological motor patterns. Conversely, those with right hemiparesis (dominant side affected) improved mainly in movement speed, indicating compensatory strategy use. Greater baseline impairment predicted larger kinematic gains, particularly in the left hemiparesis group.

These findings support BRAT as an effective intervention for chronic stroke and underscore the importance of lesion side in shaping recovery profiles, with implications for personalized rehabilitation planning.

Conditions

Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RHS

Right Hemisphere affected

Group Type: EXPERIMENTAL

Robotic arm exoskeleton integrated with cognitively engaging serious games

Intervention Type: DEVICE

A specific sequence of exercises including passive and active- assisted movements, unilateral and bilateral reaching tasks with visual feedback and bimanual symmetric and asymmetric coordination tasks.

LHS

Left Hemisphere affected

Group Type: EXPERIMENTAL

Robotic arm exoskeleton integrated with cognitively engaging serious games

Intervention Type: DEVICE

A specific sequence of exercises including passive and active- assisted movements, unilateral and bilateral reaching tasks with visual feedback and bimanual symmetric and asymmetric coordination tasks.

Interventions

Robotic arm exoskeleton integrated with cognitively engaging serious games

A specific sequence of exercises including passive and active- assisted movements, unilateral and bilateral reaching tasks with visual feedback and bimanual symmetric and asymmetric coordination tasks.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• first-ever unilateral stroke event;
• upper limb paresis with the ability to perform at least antigravity movements of the upper limb;
• right- hand dominance.

Exclusion Criteria

• impossibility to provide informed consent;
• cognitive impairment limiting the ability to understand the therapist's directions (screening Mini-Mental State Examination score <24/30);
• hemispatial neglect, severe memory/attention impairment or severe aphasia;
• degree of spasticity of the upper limb such as to make the use of robotic devices impossible (Modified Ashworth Scale score > 3).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carmelo Chisari

OTHER

Sponsor Role: lead

Responsible Party

Carmelo Chisari

Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

AOUP

Pisa, Pisa, Italy

Countries

Italy

Other Identifiers

17605

Identifier Type: -

Identifier Source: org_study_id