Cognitive Recovery Via Sensor-based Robotic Upper Limb Rehabilitation in Neurological Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorIRCCS Centro Neurolesi Bonino Pulejo
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years;
FMA-UL 0-31: eligible for exoskeletons and robotic devices with high support. (Armeo Power, Amadeo, Motore)
FMA-UL 32-47: eligible for end-effectors with medium support. (Armeo Spring, Hand Tutor, Diego)
FMA-UL 48-52: eligible for sensor-based with low support. (Pablo, Diego, Armeo Senso)
Disqualifiers
Severe cognitive disorders
Behavioral disorders
Sensory disorders
Trial design
Design model
Parallel
Treatments tested in this trial
Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR)
DeviceParticipants 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
DeviceParticipants 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.
Treatment groups
189 Participants
are divided into 2 treatment groupsGroup A: Sensor-Based Robotic Rehabilitation with Cognitive Tasks (SBRR)Experimental treatment 1 intervention
Group B: Standard Conventional Therapy (SCT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Between-group difference in change from baseline in Addenbrooke's Cognitive Examination-Revised (ACE-R) total score (Parkinson's disease)
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.
Time frame
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).2
Between-group difference in change from baseline in Brief Repeatable Neuropsychological Test (BRNT) composite score (Multiple Sclerosis)
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.
Time frame
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).3
Between-group difference in change from baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Scale Index score (Stroke)
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.
Time frame
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).Secondary outcomes
1
Between-group difference in change from baseline in Fugl-Meyer Assessment-Upper Extremity (FMA-UE/FMA-UL) score
FMA-UE score ranges from 0 to 66, with higher scores indicating better upper-limb motor function. FMA-UL will be assessed at T0 and T1. Metric: change from baseline (T1 - T0). Summaries: mean (SD) change and between-group comparison.
Time frame
From baseline (T0) to immediately after the final rehabilitation session (T1; after completion of 25 sessions; 2-3 sessions/week; 60 minutes/session; total duration ~8-12 weeks).2
System Usability Scale (SUS) score for robotic device usability at end of treatment
SUS total score ranges from 0 to 100, with higher scores indicating better usability. Participants will complete the SUS at T1 to evaluate usability of the robotic device. Metric: SUS total score. Summaries: mean (SD) (or median \[IQR\]).
Time frame
From baseline (T0) to immediately after the final rehabilitation session (T1; after completion of 25 sessions; 2-3 sessions/week; 60 minutes/session; total duration ~8-12 weeks).3
Goal Attainment Scaling (GAS) T-score at end of treatment
GAS is calculated as a standardized T-score typically centered at 50 (SD 10); scores \>50 indicate better-than-expected goal attainment, while scores \<50 indicate less-than-expected attainment. Individualized rehabilitation goals will be defined at baseline and evaluated at T1 using GAS. Metric: GAS T-score at T1 (or change, se lo calcoli). Summaries: mean (SD) and between-group comparison.
Time frame
From baseline (T0) to immediately after the final rehabilitation session (T1; after completion of 25 sessions; 2-3 sessions/week; 60 minutes/session; total duration ~8-12 weeks).Sponsors and contacts
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Source ClinicalTrials.gov