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Bilateral Robotic Rehabilitation in Chronic Stroke

Efficacy and Neurophysiological Correlates of a Bilateral Robotic Treatment for Patients With Chronic Stroke Outcomes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07145476
Acronym
BILAT
Enrollment
24
Registered
2025-08-28
Start date
2020-09-10
Completion date
2022-09-10
Last updated
2025-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Robotic, Neuroplasticity, Personalized Rehabilitation

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.

Interventions

DEVICERobotic 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.

Sponsors

Carmelo Chisari
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Changes in Fugl-Meyer for the Upper Limb (UEFM) scale pre vs post trainingFrom 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 T1The Fugl-Meyer for the Upper Limb ranges from 0 to 66, with higher scores indicating better performance
Changes in Motricity Index (MI) scale pre vs post trainingFrom 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 T1The Motricity Index ranges from 0 to 100, with higher scores indicating better performance
Changes in Bimanual Activity Test (BAT) scale pre vs post trainingFrom 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 T1The Bimanual Activity Test ranges from 0 to 100, with higher scores indicating better performance

Secondary

MeasureTime frameDescription
Changes in movement smoothness pre vs post trainingFrom the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0The smoothness of patients' movements during reaching tasks with the exoskeleton will be measured using the modified Spectral ARC length (SPARC), with higher scores indicating better performance
Changes in movement duration pre vs post trainingFrom the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0The duration of patients' movements during reaching tasks with the exoskeleton will be measured in seconds, with shorter durations indicating better performance

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026