Cognitive Recovery Via Sensor-based Robotic Upper Limb Rehabilitation in Neurological Disorders

Condition(s) studied

Investigational drug(s) / intervention(s)

Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR): Participants receive upper limb rehabilitation using sensor-based robotic devices (e.g., Motore, Armeo Senso, Hand Tutor, Armeo Power, Armeo Spring, Pablo, Amadeo, Diego) combined with virtual reality exercises. The intervention integrates cognitive tasks-such as attention, memory, and executive function exercises-simultaneously with motor training. Therapy is personalized in real-time according to each patient's performance, adjusting difficulty, intensity, and assistance levels to maximize both cognitive and motor recovery.

Standard Conventional Therapy: Participants receive traditional upper limb rehabilitation, including standard physiotherapy exercises without robotic assistance or integrated cognitive tasks. Therapy focuses on motor recovery using conventional methods, such as repetitive movement exercises, range of motion, and functional tasks, but does not adapt in real-time to patient performance and does not include concurrent cognitive stimulation.

Study summary

The goal of this clinical trial is to learn if sensor-based robotic upper limb rehabilitation can improve cognitive and motor functions in adults with neurological and neurodegenerative disorders, including Parkinson's disease, multiple sclerosis, and stroke. The main questions it aims to answer are:

Does sensor-based robotic rehabilitation improve cognitive functions such as attention, memory, and executive functions? Does this rehabilitation lead to better motor recovery and daily functioning compared to conventional therapy? Researchers will compare the experimental group receiving robotic rehabilitation with cognitive tasks to the control group receiving conventional therapy to see if the robotic approach leads to greater improvements in both cognitive and motor outcomes.

Participants will:

Receive upper limb rehabilitation using robotic devices and virtual reality-based exercises or conventional therapy Complete a series of neuropsychological assessments before and after the intervention to measure cognitive changes Complete motor function tests before and after the intervention to evaluate physical improvements Participate in 25 training sessions, 2-3 times per week, each lasting 60 minutes

Eligibility

Primary outcome measure(s)

• Between-group difference in change from baseline in Addenbrooke's Cognitive Examination-Revised (ACE-R) total score (Parkinson's disease) — From baseline (Visit 1) to end of treatment (Visit 2; after completion of 25 rehabilitation sessions; 2-3 sessions/week; each session 60 minutes; total duration ~8-12 weeks).
  Addenbrooke's Cognitive Examination-Revised (ACE-R) total score ranges from 0 to 100, with higher scores indicating better cognitive performance. ACE-R will be administered at baseline (T0) and at end of intervention (T1). The primary metric will be change from baseline (T1 - T0) in ACE-R total score. Results will be summarized as mean (SD) change (or median \[IQR\] if non-normal) and compared between robotic rehabilitation and conventional therapy groups.
• Between-group difference in change from baseline in Brief Repeatable Neuropsychological Test (BRNT) composite score (Multiple Sclerosis) — From baseline (Visit 1) to end of treatment (Visit 2; after completion of 25 rehabilitation sessions; 2-3 sessions/week; each session 60 minutes; total duration ~8-12 weeks).
  The BRB-N is a neuropsychological battery (multiple subtests). Subtest scores will be standardized into z-scores and aggregated into a composite (e.g., mean z-score across predefined subtests). Z-scores have no fixed minimum or maximum; higher values indicate better cognitive performance.The BRNT will be administered at T0 and T1. The primary metric will be change from baseline (T1 - T0) in a composite score derived from BRNT components (standardized z-scores aggregated into a single composite). Results will be summarized as mean (SD) change and compared between groups.
• Between-group difference in change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index score (Stroke) — From baseline (Visit 1) to end of treatment (Visit 2; after completion of 25 rehabilitation sessions; 2-3 sessions/week; each session 60 minutes; total duration ~8-12 weeks).
  RBANS Total Scale Index score ranges from 40 to 160, with higher scores indicating better cognitive performance. RBANS will be administered at T0 and T1. The primary metric will be change from baseline (T1 - T0) in RBANS Total Scale Index score. Results will be summarized as mean (SD) change (or median \[IQR\]) and compared between robotic rehabilitation and conventional therapy groups.

Trial sites (1)

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