An observational study in Amyotrophic Lateral Sclerosis and Health Adult Subjects, sponsored by University of Pisa. Completed at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Pisa · Observational
Among 89 studies in Amyotrophic Lateral Sclerosis with a site in Italy — 27 open to participants now, 36 under way, 7 of them phase 3. Amyotrophic Lateral Sclerosis · Italy.
Among the 89 studies in Amyotrophic Lateral Sclerosis with a site in Italy, this one is the 18th largest by enrollment of the 20 observational ones, is one of 7 that started in 2026, is one of 20 observational ones, and was the 84th registered.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
This study's enrollment of 52 is below the median of 108 across 265 observational studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →27 of the 89 studies in Amyotrophic Lateral Sclerosis with a site in Italy are open now, in 12 countries. Each count lists the studies.
Of the 192 Amyotrophic Lateral Sclerosis studies recruiting now, 117 (61%) set no upper age limit and 23 (12%) stop at 75 or younger; 15 take children under 18; 55 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →89 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 7 started in 2026.
Median enrollment 87 across the 69 interventional studies, 200 across the 20 observational. Of the 46 that completed or were terminated, 23 (50%) have results posted.
34 of 89 have an industry lead sponsor. The 10 most frequent:
University of Pisa is the lead sponsor of 113 studies on the registry; 28 are open to participants now.
University of Pisa has 1 study filed under Amyotrophic Lateral Sclerosis — fewer than ten, so there is no comparison to draw.
11 of the studies in Amyotrophic Lateral Sclerosis with a site in Italy that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06126315Phase 3Mario Negri Institute for Pharmacological ResearchTrial on the Biological and Clinical Effects of Acetyl-L-carnitine in ALS | 2027-04 |
| NCT04856982Phase 3BiogenStudy to Learn If Tofersen (BIIB067) Can Delay ALS Symptoms and About Its Safety in Adults With a SOD1 Gene Mutation Who Have Not Yet Developed ALS Symptoms | 2027-08-07 |
| NCT06881979Istituti Clinici Scientifici Maugeri SpAHigh-Tech Rehabilitation Pathway for Chronic Adult Neuromuscular Diseases - Fit4MedRob-Chronic MND Project | 2026-11 |
| NCT07616050Marta MondelliniEvaluation of the Impact of Virtual Park on Training Motivation in Adult Patients | 2026-12 |
| NCT06318585Istituto Auxologico ItalianoCreation of a Clinical Database for the Study of Phenotypic Variability in Motor Neuron Diseases | 2026-12-31 |
Among the 89 studies in Amyotrophic Lateral Sclerosis with a site in Italy, from their registry updates:
The ALTER-EGO study is a monocentric, observational clinical investigation designed to evaluate the safety, usability, and feasibility of the humanoid robotic platform Alter-Ego as an assistive device in hospital and simulated home-care settings. The system is intended to support healthcare and rehabilitation professionals in the management of patients with Amyotrophic Lateral Sclerosis (ALS). Alter-Ego is an anthropomorphic, wheeled, self-balancing social robot equipped with compliant robotic arms and SoftHand synergistic grippers. It operates in teleoperated, semi-autonomous, or fully autonomous modes and integrates advanced navigation, mapping, object manipulation, and natural language processing capabilities. The robot is not classified as a medical device under EU Regulation 2017/745, as it does not perform diagnostic or therapeutic functions, but provides logistical, communicative, and organizational support.
The study is conducted at ICS Maugeri IRCCS (Milan Camaldoli). Participants include healthcare professionals (physicians, nurses, physiotherapists, occupational therapists, speech therapists, and healthcare assistants) and up to 40 hospitalized ALS patients. Patients are not direct operators of the robot but provide experiential feedback through questionnaires and qualitative interviews.
A total of 40 experiments are organized into four clusters:
Cluster 1 - Telemedicine (Teleoperated or Semi-Autonomous Mode)
Within a simulated home-care environment, Alter-Ego supports remote clinical and rehabilitation activities through four specific tasks:
Simulated Remote Medical Visit (First Home Transition):
A physician conducts a tele-visit via the robot, asking health-related questions, performing visual neurological assessments using cameras and microphones, requesting specific motor tasks, and reviewing vital parameters from home monitoring devices. This task addresses the need for expert supervision during early discharge phases.
Assistive Device Training:
A physiotherapist and nurse remotely verify and guide the correct use of assistive devices such as non-invasive ventilation systems, PEG, or patient lifters, providing practical instructions to patients and caregivers.
Home Environment Assessment:
An occupational therapist uses the robot in semi-autonomous mode to map the domestic environment and, in tele-guided mode, visually inspect spaces to identify architectural barriers and optimize assistive device placement.
Telerehabilitation:
Physiotherapists and speech therapists use the robot's audio-video interface and display to conduct remote rehabilitation sessions and functional evaluations, providing visual and verbal feedback.
Cluster 2 - Delivery Services (Autonomous Mode) The robot autonomously transports small items within the hospital ward, including medical records, blood collection kits, rehabilitation tools, and small food or beverage packages.
Cluster 3 - Guidance and Welcome Assistance (Autonomous Mode) Alter-Ego presents ward service information to newly admitted patients and provides personalized daily reminders regarding scheduled rehabilitation activities.
Cluster 4 - Monitoring (Autonomous Mode) The robot administers the Visual Analog Scale (VAS) for pain assessment and includes an exploratory function for detecting vocal distress keywords (e.g., "pain," "help," "thirst") using AI-based speech recognition, alerting staff when necessary.
Primary endpoints include usability and feasibility (System Usability Scale - SUS; Questionnaire for User Interaction Satisfaction - QUIS; NASA Raw Task Load Index - NASA-RTLX; State-Trait Anxiety Inventory - STAI) and safety assessment through systematic recording of adverse events.
Secondary outcomes include healthcare professionals' satisfaction with autonomous robot performance, patient satisfaction (Likert scales), and psychosocial impact on professionals (selected PIADS items).
Additional exploratory assessments investigate subjective factors that may influence usability and feasibility. Before the first interaction, patients and professionals complete a short questionnaire on prior experience with robots, expectations, and initial perception of Alter-Ego. Perception measures (anthropomorphism, agency and experience, warmth and competence, perceived closeness) are repeated after each experiment. At the end of each experiment, participants take part in a semi-structured qualitative interview (15-30 minutes), audio/video recorded only with specific consent and analyzed through reflexive thematic analysis.
The ALTER-EGO study aims to determine whether an anthropomorphic robotic platform can safely and effectively support multidisciplinary ALS care, improve workflow efficiency, and enhance patient-centered assistance in both hospital and transitional home-care settings.
Pre/post assessment of robot perception Before the first interaction with Alter-Ego, patients and healthcare professionals complete a short questionnaire collecting information on prior experience with robots and technology, prior knowledge of Alter-Ego, expectations about its functioning, and initial perception of its appearance and capabilities. This baseline assessment documents the initial perception of the robot before it can be modified by direct experience, and allows the influence of technological familiarity, expectations and attitudes on the subsequent evaluation of the system to be taken into account. After each experiment, the following perception measures are repeated: perceived anthropomorphic appearance (3 items adapted from Ferrari et al., 2016), mind perception - agency and experience (8 items adapted from Gray et al., 2007), perceived warmth and competence (12 items adapted from Fiske et al., 2007), and perceived closeness (Inclusion of Other in the Self scale, Aron et al., 1992). The pre/post comparison is used to interpret usability and feasibility results and to identify factors contributing to participants' responses.
Semi-structured qualitative interview At the end of each experimental session, patients and healthcare professionals are invited to a semi-structured qualitative interview (approximately 15-30 minutes) conducted by an experienced researcher. Topics include expectations prior to meeting the robot, perception of the robot (appearance, movements, appropriateness to the hospital context), the experience during the task, and the evolution of perception across sessions. For healthcare professionals, the interview also explores the teleoperation experience and the robot-mediated relationship with the patient, involvement in the introduction and planning of robot use, and opinions on the future role of autonomous robots in healthcare. For patients, questions are adapted to the operating mode experienced (teleoperated or autonomous).
Recording and data management Interviews may be audio- and video-recorded only with the participant's specific consent. Refusal of recording does not preclude participation; in that case, written notes are taken by the researcher. Video is used only to support transcription and quality control and is not analyzed. Recordings are acquired with a webcam (Logitech Brio 4K) managed with the open-source software Webcamoid, transferred to a password-protected study computer, and deleted from the acquisition device. Preliminary transcription is performed with Vibe (open-source, based on OpenAI Whisper) in offline/local mode only, with no data sent to external servers. Transcripts are manually revised and pseudonymized, then analyzed with MAXQDA (offline version) using reflexive thematic analysis. Recordings are deleted after transcription and quality control. Access is restricted to authorized researchers, in compliance with EU Regulation 2016/679 (GDPR).
Patients with Amyotrophic Lateral Sclerosis hospitalized in the ALS unit at ICS Maugeri IRCCS, Milan.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthcare Professionals
Patients
Absence of psychiatric disorders or psychological conditions that, in the physician's judgment, could cause stress during interaction with the robot.
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Healthcare Professionals
1. Health conditions that, in the clinician's judgment, could make the use of the Alter-Ego system via a head-mounted display unsafe or inappropriate.
Patients
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The SUS (System Usability Scale) assessment is conducted after each experimental session.
The System Usability Scale is a scale that contains ten questions used to assess system usability (from 1 to 5, where 1 means complete disagreement with the statement and 5 means complete agreement).
Time frame: up to 24 weeks
The QUIS (Questionnaire for User Interaction Satisfaction) assessment is conducted after each experimental session.
QUIS (Questionnaire for User Interaction Satisfaction) is a tool developed to assess users' subjective satisfaction with specific aspects of the human-computer interface. The QUIS contains a measure of overall system satisfaction across six sub-scales and measures four specific interface factors. Each area measures overall satisfaction on a 9-point scale (from 1 to 9), where a lower score indicates a worse outcome.
Time frame: up to 24 weeks
The NASA RTLX (NASA Raw Task Load Index) assessment is conducted after each experimental session.
The NASA Raw Task Load Index (RTLX) is a simplified, unweighted version of the standard NASA-TLX, used to measure subjective cognitive workload across six dimensions: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration. Each dimension is rated for each task on a 100-point scale with 5-point increments. A lower score indicates a better outcome.
Time frame: up to 24 weeks
Change in perception of the robot (pre vs post interaction)
Perceived anthropomorphic appearance (3 items adapted from Ferrari et al., 2016; 5-point Likert scale, 1-5, higher = more human-like), mind perception - agency and experience (8 items adapted from Gray et al., 2007; 5-point Likert scale, 1-5, higher = greater attribution), perceived warmth and competence (12 items adapted from Fiske et al., 2007; 7-point Likert scale, 1-7, higher = greater warmth/competence), and perceived closeness (Inclusion of Other in the Self scale, Aron et al., 1992; 1-7, higher = greater closeness). Administered to patients and healthcare professionals.
Time frame: up to 24 weeks
Participants' subjective experience of interaction with Alter-Ego (qualitative)
Themes identified through reflexive thematic analysis of semi-structured interviews with patients and healthcare professionals, exploring expectations, perception of the robot, experience during the tasks, and factors facilitating or hindering usability, feasibility and acceptance.
Time frame: up to 24 weeks
Ran from Jun 2026 to primary completion in Oct 2026, 4 months.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: start May 2026 → Jun 2026, primary completion Aug 2026 → Oct 2026 and completion Nov 2026 → Oct 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Amyotrophic Lateral Sclerosis →