An interventional study of Robotic arm exoskeleton integrated with cognitively engaging serious games in Stroke, sponsored by Carmelo Chisari. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Carmelo Chisari · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 24 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Carmelo Chisari is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Right Hemisphere affected
Device: Robotic arm exoskeleton integrated with cognitively engaging serious games
Left Hemisphere affected
Device: 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.
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
Time frame: 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
Time frame: 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
Time frame: 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 movement smoothness pre vs post training
The 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
Time frame: 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
The duration of patients' movements during reaching tasks with the exoskeleton will be measured in seconds, with shorter durations indicating better performance
Time frame: From the pre-training evaluation (T0) to the post-training evaluation (T1), about 3 weeks after T0
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carmelo Chisari