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Artificial Intelligence in Health                                 Robotics and Vivaldi AI for ALS assessment



            Bland–Altman plot is a graphical method to compare two   we integrated this questionnaire into the Sanbot Elf robot,
            measurements techniques, 31,32  also providing a quantitative   leveraging the advanced capabilities of the Vivaldi AI system
            estimate of how closely the values from two measurements   to create an adaptive and user-friendly interface for patients.
            lie.  In this context, we reported both the bias (mean of the   The ALSFRS-R questionnaire, embedded in the chest
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            differences between the two methods) and the 95% limits   tablet interface of the Sanbot Elf, comprises 12 items that
            of agreement (LOA). The ICC provides a single measure of   assess four key domains: bulbar function, fine motor
            the extent of agreement between the two methods,  and   function, gross motor function, and respiratory function.
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            we considered the guidelines recommended by Koo and   Each item is scored 0 (complete loss of function) to 4
            Li for interpreting the results.  In detail, basing on the   (normal function), enabling a thorough evaluation of the
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            95% confident interval of the ICC estimate, values <0.5,   patient’s abilities.
            between 0.5 and 0.75, between 0.75 and 0.9, and >0.90 are
            indicative of poor, moderate, good, and excellent reliability,   In a hospital setting, the Sanbot Elf administered the
            respectively.  Moreover, to longitudinally quantify the   ALSFRS-R questionnaire through an interactive process
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            heterogeneity in rates of decline in ALSFRS-R between   tailored to the specific needs of ALS patients, with a typical
            individuals, we calculated the coefficient of variation (CoV).   duration  of  approximately  10  –  15  min.  The  Vivaldi  AI
            The CoV was defined as the between-patient standard   system guided this administration, ensuring a smooth and
            deviation of slope divided by the mean rate of change, and   adaptive experience. Patients responded to each question
            a lower value indicates both a less variation among patients,   using a simple “yes” or “no” format, which minimizes
            which could positively affect sample size calculations, and an   ambiguity and ensures clarity in their responses, and the
            increase of the sensitivity in detecting disease progression.   Vivaldi AI system dynamically adjusted the sequence of
            Finally, a mixed-effects linear regression with ALSFRS-R   questions based on the patient’s responses.
            (total score and subgroups, separately) as the outcome, and   Sanbot Elf offers multiple interaction modes to
            fixed-effects for time, approach (human operator vs. robotic   accommodate the diverse needs of ALS patients. Indeed,
            operator), and an interaction between time and approach. In   patients with limited mobility but who can speak
            detail, the fixed effect for the interaction between approach   were able to interact verbally with the robot. For those
            and time was used as an assessment of bias in the human-  experiencing dysarthria or hypophonia, the touchscreen
            based score compared to the robot-based score. Considering   interface provided an alternative method for responding to
            the psychological assessment, a paired  t-test was used to   questions. This dual-mode interaction ensured inclusivity
            evaluate the impact of the questionnaire’s administration   and accessibility for all patients.
            by the robotic operator on patients’ anxiety, comparing the
            state anxiety level pre- and post-administration. Finally, the   In addition, patients could use vocal commands to
            correlation  between  the  bias  in  evaluating  the  ALSFRS-R   request repetitions of questions or take brief pauses, a
            between the two methods and the “openness to experience”   feature facilitated by the Vivaldi AI system (this could
            dimension of the BFI was evaluated using Spearman’s rank   cause an increase in the time required to administer the
            correlation coefficient. Regarding the qualitative analysis   questionnaire, without negatively influencing the operator’s
            collected from the observational grid and the semi-  burden). This enhanced comfort and ease of use, catering
            structured interview, frequency and percentage were used to   to patients who might need more time or clarification.
            investigate the emotional states and the patients’ perception   On  completion  of  the  questionnaire,  the  Vivaldi  AI
            about the experience. Specifically, considering the analysis   system automatically calculated the final ALSFRS-R score,
            of the semi-structured interview, a cluster’s identification   promptly providing results. This score is useful for ongoing
            was obtained by analyzing the answers given by patients   monitoring and assessment of the patient’s functional
            for the categories of each thematic area. All statistical tests   status and disease progression. The automated scoring
            were two-tailed, and P < 0.05 was considered statistically   process ensures accuracy and consistency, minimizing the
            significant. All the statistical analyses were performed using   risk of human error.
            SAS 9.3 (SAS Institute, Inc, Cary, NC) software. For the text
            analysis, the Atlas.ti software was used.          5.2. Agreement analysis between human and
                                                               robotic ALSFRS-R assessment
            5. Results
                                                               A group of 28 ALS patients participated in this study, with
            5.1. Design and implementation of the ALSFRS-R in   a median age at evaluation of 62.37  years (range: 53.88
            Sanbot Elf                                         – 68.43) and a male-to-female ratio of 2.11. Descriptive
            The ALSFRS-R questionnaire is an essential tool for   characteristics of the ALS cohort, including demographic
            evaluating the functional status of ALS patients. In our study,   and clinical features, are summarized in Table 1.


            Volume 1 Issue 4 (2024)                         78                               doi: 10.36922/aih.3732
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