Exploring Cognitive Recovery: the Impact of Sensor-based Robotic Rehabilitation in Neurological and Neurodegenerative Disorders
Phase: NA
Conditions: PARKINSON DISEASE (Disorder), Multiple Sclerosis, Stroke, Neurological Disorders
Sponsor: IRCCS Centro Neurolesi Bonino Pulejo

 
 
Title of the study: “Exploring Cognitive Recovery: The Impact of Sensor-Based Robotic 
Rehabilitation in Neurological and Neurodegenerative Disorders” 
 
Protocol Version n. 2 of 07/01/2025 
Identification code: CROSS-ND 
Study center: IRCCS Centro Neurolesi “Bonino-Pulejo”, Via Palermo S.S.113 - 98124 (ME) 
 
Study manager 
Dr Desirèe Latella 
 
 
Clinical team: Dr Desirèe Latella, Dr Mirjam Bonanno, Dr Mariagrazia Maggio; Dr Roberta 
Cellini, Dr Chiara Sorbera, Dr Rocco Salvatore Calabrò, Dr Giuseppe Di Lorenzo, Dr Francesca 
Antonia Arcadi, Dr.Edoardo Sessa 
 
Data processing and statistical analysis: Dr Lilla Bonanno 

 
 
 
 
 
 
RATIONALE FOR THE STUDY 
 
Robotic therapy is a well-established approach for upper limb rehabilitation in neurological and 
neurodegenerative populations, allowing clinician teams to increase the intensity and standardization 
of therapy. A key strength of robotic therapy is the possibility to personalize treatment in real-time 
based on a patient’s performance, offering therapy that tailors the levels of difficulties, intensity, 
required movements, assistance levels, and workspace according to the patient’s progress. This 
feature not only enhances motor recovery but also improves engagement and motivation, promoting 
neuroplasticity—a critical factor in the long-term recovery of neurological functions. In a Cochrane 
Review on cognitive rehabilitation for attention deficits1 , the authors highlight that improving 
attention, also in the short term, is very important during motor and functional rehabilitation 
programs because high attention may enable people to engage better with the exercises proposed with 
a high ability to cope with proposed tasks. Given the inter-relationship between cognitive and motor 
functions, improvements in motor skills may not always lead to functional gains in activities of daily 
living without addressing cognitive impairments. For instance, deficits in attention and executive 
functioning can hinder a patient's ability to perform daily tasks despite motor recovery. This 
highlights the necessity for a more integrated approach to rehabilitation that concurrently addresses 
both motor and cognitive domains. In the last years, robotics rehabilitation, has included exercises 
stimulating cognitive functions, which can be proposed and performed during motor exercises. 
Several studies confirmed the high prevalence of cognitive impairment in neurological and 
neurodegenerative disorders2-7 underlining its significant influence on motor learning strategies8, 
functional recovery, and quality of life. Nevertheless, usually, the aim of the robotic treatment is the 

improvement in motor performance and activities of daily living, while the cognitive deficits are often 
ignored or treated separately from motor impairment. A cognitive treatment is crucial for the subjects 
in which cognitive and motor impairments are often present at the same time, such as neurological 
patients9 . Many studies have found that improvements in upper limb motor function do not always 
lead to progress in activities of daily living, such as dressing or eating. This may be because cognitive 
impairments, which often accompany motor issues, are not sufficiently addressed. Few studies 
explored the cognitive effects of a robotic rehabilitation program10-11, and they did not use tools to 
investigate specific cognitive functions. After upper limb robotic treatment, all the explored cognitive 
domains significantly improved, such as attention and processing speed, visuospatial abilities, visual 
memory, executive functions, and memory. The implementation of cognitive tasks within robotic 
therapy, such as dual-task or feedback mechanisms, has the potential to stimulate cognitive processes 
directly linked to everyday functioning, including memory, visuospatial abilities, and problem- 
solving.12 This can promote neuroplasticity by simultaneously engaging multiple brain networks, 
thereby promoting broader neurological recovery. Moreover, robotic devices ensure consistent and 
reproducible therapy. Intensive and repetitive rehabilitation training are essential for regaining motor 
functions, which can be challenging to achieve with traditional therapy13. An adaptive robotic training 
offers unique advantages for neurological and neurodegenerative patients, as well as the capacity to 
adjust task difficulty in real-time to ensuring the patient remains cognitively engaged. This continuous 
engagement is essential to improve neuroplasticity mechanisms that support both motor and cognitive 
recovery. Robotic therapy is not only as effective but potentially more beneficial in specific cases due 
to its precision and customization14. Several studies, including systematic reviews, have shown that 
robot training not only improves activities of daily living but also enhances muscle strength and 
function in the affected arm15. Two recent large-scale studies further support this, demonstrating that 
robotic therapy is at least as effective as conventional therapy in improving motor outcomes16. The 
most recent meta-analysis suggests that robotics can improve upper limb motor function and muscle 
strength15, and, when compared to a similar amount of conventional therapy, no significant 
differences in terms of motor recovery are detected17. In fact, some research suggests that robotic- 

assisted rehabilitation might provide an edge due to its precision and ability to customize the difficulty 
of each task, offering a personalized and engaging approach18. The limited focus on cognitive 
rehabilitation in existing studies may contribute to better outcomes, as well as patients with 
concurrent cognitive deficits may not fully benefit from motor rehabilitation alone. A systematic 
review revealed that only 15% of stroke rehabilitation trials included patients with cognitive 
impairments, underscoring a significant research gap that needs to be addressed to improve the 
inclusivity and efficacy of robotic interventions. The efficacy of robotics in recovering cognitive 
deficits was few explored. To date, the implementation of new graphical interfaces and more 
ecological scenarios, as well as more cognitively demanding tasks, can allow an active physical and 
cognitive engagement of patients during robotic therapy, due to a variety of solutions with different 
levels of technology, assistance, and complexity of exercises. This can be promoted through adaptive 
assistance, cognitive challenge19, visual and auditory feedback to enhance patient's engagement20 
facilitating neuronal reorganization in the motor cortex 21-22-23-24-25. 
The present study aims to assess the effectiveness of upper limb rehabilitation using robotics and 
virtual reality, comparing it to conventional therapy. The objective is to demonstrate that this 
innovative approach leads to more significant improvements in both motor and cognitive outcomes. 
Both the experimental and control groups will follow a rehabilitation program that involves not only 
the upper limb but also other body regions. The comparison between the two groups will be based on 
the analysis of cognitive and motor outcomes achieved in relation to upper limb rehabilitation. 
Therefore, we hypothesize that a robotic treatment, based on the execution of selected exercises, 
based on concurrent motor/cognitive tasks can improve cognitive deficits beyond motor function in 
patients with neurological and neurodegenerative disorder. The current study evaluates the cognitive 
effects of upper limb robotic rehabilitation training in neurological and neurodegenerative conditions. 

OBJECTIVES OF THE STUDY 
 
Assess the efficacy of sensor-based robotic rehabilitation training on cognitive functioning in patients 
with neurological and neurodegenerative disorders versus conventional therapies. 
 
Primary Objectives: 
• Evaluate the effect of robotic rehabilitation on specific cognitive domains (e.g. attention, 
memory, executive functions, visual-spatial perception) in patients with neurological and 
neurodegenerative disorders. 
Criteria for the primary outcome: 
- 
Parkinson’s Disease: The ACE-R (Addenbrooke's Cognitive Examination-Revised) 
will be used to measure improvement, where significant progress in at least 2 subscales will 
indicate effective cognitive rehabilitation. 
- 
Multiple sclerosis: The Rao's Brief Repeatable Battery will assess cognitive function, 
with improvement in at least 2 subscales indicating significant recovery. 
- Stroke: The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) 
will be used, with a significant cognitive improvement marked by an increase of 10 points. 
 
 
 
Secondary Objectives: 
• Analyze the correlation between specific cognitive deficits and motor recovery in patients 
undergoing robotic rehabilitation training 
• Investigate the role of motor rehabilitation integrated with cognitive tasks in improving 
cognitive and motor functions. 
• Analyse the impact of robotic rehabilitation on mood and psychological well-being. 
• Compare the effectiveness of robotic rehabilitation training among different subgroups of 
neurological patients (Stroke- Multiple sclerosis- Parkinson's disease). 

• Explore the influence of individual patient characteristics (age, severity of cognitive 
impairment, disease stage) on cognitive rehabilitation outcomes. 
 
 
STUDY DESIGN 
 
This study is designed as a randomized controlled trial with parallel groups aimed at evaluating the 
effectiveness of upper limb rehabilitation using robotics and virtual reality in comparison to 
conventional therapy. The primary objective is to demonstrate that this innovative approach leads 
to more significant improvements in both motor and cognitive outcomes. 
Both the experimental and control groups will follow a structured rehabilitation program that 
involves not only the upper limb but also other body regions, ensuring a comprehensive approach 
to functional recovery. The experimental group will undergo robotic and virtual reality-based 
training, while the control group will receive conventional therapy. The comparison between the 
two groups will be based on the analysis of cognitive and motor outcomes related to upper limb 
rehabilitation, allowing for an in-depth assessment of the potential advantages offered by robotic 
therapy. 
 
 
 
STUDY POPULATION 
 
This study will employ purposive sampling to select participants. Purposive sampling is a non- 
probability sampling technique used when specific criteria are required to ensure the sample aligns 
with the research objectives. Purposive sampling ensures that all participants had similar 
characteristics relevant to the study's aims. Subjects who meet all inclusion criteria will be enrolled 
in the study and will be divided into two groups: 
 
 
 
• Sensor-Based Robotic Rehabilitation Group (SBRR) 
 
• Standard Conventional Therapy Group (SCT) 
 
 
 
 
 
Sample Size 

A power analysis was conducted using G*Power to determine the appropriate sample size for 
detecting a low to moderate effect (d = 0.4) with a paired t-test, a two-tailed significance level of 
0.05, and a desired power of 0.80. The analysis indicates that a minimum of 52 participants per 
group is necessary to achieve sufficient statistical power for detecting significant changes within 
each group. Accounting for a potential dropout rate of 20%, the adjusted sample size is 63 per 3 
participants per group. 
 
 
 
 
METHODS AND PROCEDURES OF THE STUDY 
The current study will follow the following timeline: 
T0. Baseline: Initially, patients will be recruited and randomly assigned to one of two groups using 
block randomization. This method divides participants into small blocks and assigns an equal number 
of patients to each group within each block. For example, in a block of four participants, two will be 
assigned to group A and two to group B. This process is repeated for each block, ensuring that both 
groups have a balanced number of participants throughout the study. 
SBRR will receive motor and cognitive rehabilitation assisted by robotic and sensor-based devices 
through Motore, Armeo Senso, Hand Tutor, Armeo Power, Armeo Spring, Pablo, Amadeo, Diego. 
SCT will receive conventional motor rehabilitation treatment. 
Subsequently, patients will undergo a neurological examination, comprehensive neuropsychological 
assessment, and motor evaluation. These assessments will be conducted in a blinded modality, with 
evaluators distinct from recruiters and therapists. Importantly, the evaluators will not be aware of the 
group assignment of the patients. 
Following these assessments, both groups will engage in their respective rehabilitation programs. 
Each session will perform for 60 minutes 2-3 times a week for a total of 25 sessions. 
T1. Post-intervention assessment: At the end of the rehabilitation program, a comprehensive 
neuropsychological and motor assessment will be conducted again. 

Cognitive Assessment: 
 
Each participant will undergoing by a neuropsychological evaluation before (T0) and immediately 
after the end of the robotic training (T1). The evaluation will conducted by neuropsychologist to 
ensure that cognitive assessments and interpretations of results remain unbiased and objective. We 
considered to used different neuropsychological tests to indagate specific cognitive domains to obtain 
a more complete neuropsychologic profile. 
Parkinson population 
 
For this target, the assessment will included a global cognitive evaluation using: Addenbroke's 
Cognitive Examination Revised (ACE-R)26 was designed as a valid screening instrument for 
cognitive profile. It assesses different cognitive domains: attention and concentration, executive 
functions, memory, language, visuo-spatial skills, conceptual reasoning and orientation; Wisconsin 
Card Sorting Test (WCST)27 assesses executive functioning, in particular, cognitive flexibility in 
problem solving, inability to abstraction and perseverance; Corsi Block-Tapping Test evaluates span 
of visual-spatial memory28; Trail Making Test (TMT)29 assesses selective attention and cognitive 
flexibility; Rey-Osterrieth Complex Figure Test30 assesses visual-constructive and visual-spatial 
memory capabilities; Symbol Digit Modalities Test (SDMT)31 examines sustained attention and 
working memory; Parkinson's disease questionnaire-39 (PDQ-39)32 is a 39-item self-report 
questionnaire, which assesses Parkinson’s disease-specific health related quality in 8 dimensions: 
Activities of Daily Living,Attention, Working Memory, Cognition, Communication, Depression, 
Functional Mobility, Social Relationships and support. 
Multiple Sclerosis population 
 
For this target, the assessment will included a global cognitive evaluation using: Brief Repeatable 
Neuropsychological Test (BRNT)33 that includes several sub-tests to assess memory, attention, and 
executive functions, specifically designed for multiple sclerosis; The MSQOL-5434 is a 
multidimensional health-related quality of life measure that combines both generic and MS-specific 
items into a single instrument. 
Stroke population 
 
For this target, the assessment will included a global cognitive evaluation using: Repeatable Battery 
for the Assessment of Neuropsychological Status (RBANS)35 is a brief, individually administered 
test that helps determine the neuropsychological status. It includes different cognitive tasks: attention 
and concentration, executive functions, memory, language, visuo-spatial skills, conceptual reasoning 

and orientation tasks; Tower of London (TOL)36 assesses the ability to plan and solve complex 
problems; Rey-Osterrieth Complex Figure Test assesses visual-constructive and visual-spatial 
memory capabilities; Stroke Specific Quality of Life Scale (SSQOL)37 assesses several domains, 
including physical function, cognition, emotions, communication, and social life. 
At the end of the rehabilitative training we used a scale for evaluate the main dimensions of usability 
by using System Usability Scale robotic (SUS-r)38 and Goal Attainment Scaling (GAS)39. 
Motor Assessment: 
Each participant will undergoing by a motor evaluation before (T0) and immediately after the end 
of the robotic training (T1). The evaluation will conducted by physiotherapist. It includes: Fugl- 
Meyer Assessment – Upper Limb (FMA-UL)40 comprises of five domains: motor functioning (in 
the upper and lower extremities), sensory functioning, balance, joint range of motion and joint pain. 
It includes items assessing movement, coordination, and reflex action of the shoulder, elbow, 
forearm, wrist, hand; Motricity Index (MI)41 for the upper limb assess upper extremity function and 
functional mobility; Disability of the Arm, Shoulder and Hand (DASH)42 assesses musculoskeletal 
disorders of the shoulder, hand and arm; Nine Hole Peg Test (9HPT)43 and Box and Block Test 
(BBT)44 measure unilateral gross manual dexterity; Test del monofilamento di Semmes Wilson 
assesses whether alterations in skin sensitivity are present. 
 
Inclusion criteria 
 
• 
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) 
• 
MoCA: ≤ 20 
 
 
 
 
 
 
 
Exclusion criteria 
 
 
• 
Severe cognitive disorders 
• 
Behavioral disorders 
• 
Sensory disorders 

DURATION OF THE STUDY 
The study duration will be 60 months. 
 
 
 
 
 
 
 
STATISTIC ANALYSIS 
 
A descriptive analysis of the sample will be performed for socio-demographic and clinical variables. 
The Shapiro-Wilk test will be applied to assess the distribution type of the variables. Continuous 
variables will then be expressed as mean±SD, while categorical variables will be presented as 
frequencies and percentages. The parameters evaluated will include the motor and cognitive test 
scores. 
 
• For intra-group analysis, a paired T-test or Wilcoxon signed-rank test will be applied, 
depending on the data type, to compare the scores between the two time points. Additionally, 
the Pearson correlation coefficient will be calculated for parametric data, or Spearman’s 
correlation for non-parametric data, to examine whether a relationship exists between 
demographic and clinical variables. Multiple regression analyses will be performed on the 
cognitive scores treated as dependent variables. Initially, we will focus on the influence of 
motor scores as predictors. A backward elimination stepwise procedure will be applied to 
select the best predictive variables according to the Akaike Information Criterion (AIC). 
• For inter-group analysis, an unpaired T-test or Mann-Whitney U test will be applied to 
compare the groups at T0 and T1. Additionally, ANCOVA will be used with T1 cognitive 
scores as the dependent variable, group (SBRR vs. SCT) as the independent variable, and T0 
cognitive scores and age as covariates, to determine whether the rehabilitation method (SBRR 
vs. SCT) has a true effect on cognitive improvement independent of baseline scores and age. 
 
All analyses will be conducted using the open-source software package R4.2.2. A 95% confidence 
level will be established, with an alpha error of 5%. Statistical significance will be set at p < 0.05. 

ETHICAL ASPECTS 
 
The principal investigator (PI) will conduct the study in accordance with the rules of good clinical 
practice (GCP) and current legislation and in accordance with the current version of the Declaration 
of Helsinki. 
 
 
 
Informed consent 
 
Written informed consent will be obtained from all study participants, in accordance with current 
regulations. The investigator will inform each patient that participation in the study is voluntary and 
that refusal will not result in the loss of any benefits or adversely affect their relationship with the 
doctor. Before enrolling in the study, each subject will receive a comprehensive explanation about 
the nature and purpose of the study from the investigator. They will also be provided with a clear 
information sheet detailing all important aspects, allowing them the opportunity to ask any questions. 
The subject will have the right to take the necessary time to consider before signing the informed 
consent (IC), of which they will receive a copy. One of the original copies of the IC will be retained 
by the investigator. 
 
 
 
Innovative Contribution of the Research and Expected Outcomes 
 
This study offers an integrated approach to rehabilitation by simultaneously addressing motor and 
cognitive impairments. Traditional therapies focus primarily on motor recovery, often overlooking 
cognitive deficits that critically influence functional independence and quality of life.1,2 Research 
aims to enhance attention, executive functions, memory, and visuospatial abilities while promoting 
motivation and engagement through adaptive and personalized interventions. 17,21 This dual focus 
leverages neuroplasticity by activating multiple brain networks, potentially achieving more robust 
recovery outcomes.12,22 Expected results include improved cognitive and motor functions, optimized 
rehabilitation protocols, enhanced patient engagement, and better quality of life. The findings aim to 
establish evidence-based guidelines for integrating cognitive tasks into robotic rehabilitation, 
advancing current clinical practices.19,20 

Protection of subject data 
 
Before conducting any examinations required by this protocol, patients will also provide all the 
authorizations mandated by law, including those required in the European Regulation 2016/679 and 
Legislative Decree 196/2003 as amended by Legislative Decree No. 101 of 10/08/2018. In adherence 
to the principles of good clinical practice, each subject will be assigned a unique code that will serve 
as their identifier for the entire duration of the study. 
 
 
 
ADMINISTRATIVE ASPECTS 
 
Ethics Committee 
 
The PI will secure approval from the ethics committee for the study protocol, informed consent (IC) 
form, and other relevant documents before starting the study. Once approved, the IC form cannot be 
altered without further approval from the ethics committee. The PI is responsible for ensuring that all 
aspects of the institutional review comply with current regulations. Any modifications to the protocol 
will undergo the same review and approval process as the original. A progress report will be submitted 
to the ethics committee at specified intervals, at least annually. Upon the study's completion or 
termination, the PI will submit a closure letter to the ethics committee. 
 
 
 
Economic aspects and insurance coverage 
 
Given the interventional nature of the study, an insurance policy will be provided in addition to that 
for normal clinical practice. 
 
 
 
PUBLICATION OF RESULTS 
Upon completion of the study, the results will be the subject of scientific publications. 

 
 
 
 
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