Bilateral Robotic Rehabilitation in Chronic Stroke

NCT07145476 | Completed

• 1 other identifier: 17605
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Robotic; Neuroplasticity; Personalized Rehabilitation

Outcome Measures

Primary Outcomes (3)

• Changes in Fugl-Meyer for the Upper Limb (UEFM) scale pre vs post training

  The Fugl-Meyer for the Upper Limb ranges from 0 to 66, with higher scores indicating better performance

  From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0, to the follow up T2, about 2 months after T1

• Changes in Motricity Index (MI) scale pre vs post training

  The Motricity Index ranges from 0 to 100, with higher scores indicating better performance

  From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0, to the follow up T2, about 2 months after T1

• Changes in Bimanual Activity Test (BAT) scale pre vs post training

  The Bimanual Activity Test ranges from 0 to 100, with higher scores indicating better performance

  From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0, to the follow up T2, about 2 months after T1

Secondary Outcomes (2)

• Changes in movement smoothness pre vs post training

  From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0

• Changes in movement duration pre vs post training

  From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0

Study Arms (2)

RHS

EXPERIMENTAL

Right Hemisphere affected

Device: Robotic arm exoskeleton integrated with cognitively engaging serious games

LHS

EXPERIMENTAL

Left Hemisphere affected

Device: Robotic arm exoskeleton integrated with cognitively engaging serious games

Interventions

Robotic arm exoskeleton integrated with cognitively engaging serious games 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; RHS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: All
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Carmelo Chisari: lead

Study Sites (1)

AOUP

Pisa, Pisa, 56124, Italy

Location

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 28, 2025
• Study Start: September 10, 2020
• Primary Completion: September 10, 2022
• Study Completion: September 10, 2022
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)