Amyotrophic Lateral SclerosisAlter-EgoNCT07572838
Alter-Ego as an Assistive Robotic Device.
An observational study of Amyotrophic Lateral Sclerosis and Health Adult Subjects, run by University of Pisa at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Health Adult Subjects
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2026to 15 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Amyotrophic Lateral Sclerosis hospitalized in the ALS unit at ICS Maugeri IRCCS, Milan.
Who may be able to join
- Healthcare Professionals
- Age within the legal working age range for professional employment.
- Experience in the management and treatment of patients affected by motor neuron disease.
- Expected employment at ICS Maugeri IRCCS, Milan Camaldoli, for the entire duration of the study.
- Ability to understand and provide informed consent.
- Patients
Show all 11Show fewer
- Diagnosis of possible, probable, or definite Amyotrophic Lateral Sclerosis (ALS) according to the El Escorial criteria.
- Adults aged between 18 and 80 years.
- Ability to understand and provide informed consent.
- Absence of psychiatric disorders or psychological conditions that, in the physician's judgment, could cause stress during interaction with the robot.
- ---
Who cannot join
- 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
- Individuals with severe psychiatric disorders or cognitive impairments that compromise the ability to complete assessment scales (based on medical history data).
- Individuals with moderate to severe cognitive impairment, defined as a score below 81.92 on the ECAS questionnaire (routinely administered during the first days of hospitalization).
- Individuals in isolation due to infectious causes.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute
Milan, Milan, 20138
About this study
Official title: Alter-Ego as an Assistive Robotic Device for Hospital and Domestic Applications.
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.
Read more
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.
Read the detailed description
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).
- Keywords
- Humanoid robotic platform, Assistive Device, Telemedicine, Healthcare
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ALS patient | Not described | |
| Healthcare Professionals | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Jun 2026
- Primary completion15 Oct 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pisa
- Sponsor type
- University, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA
- Responsible party
- Principal investigator, Antonio Bicchi, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572838
- Sponsor's protocol ID
- CTSM155-24
- Acronym
- Alter-Ego
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alter-Ego as an Assistive Robotic Device for Hospital and Domestic Applications.
- ClinicalTrials.gov ID
- NCT07572838
- Acronym / sponsor ID
- Alter-Ego / CTSM155-24
- Keywords
- Humanoid robotic platform, Assistive Device, Telemedicine, Healthcare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of PisaUniversity, hospital or other
- Collaborators
- Istituti Clinici Scientifici Maugeri SpA
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 15 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 7 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALS patient | – | – |
| Healthcare Professionals | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Amyotrophic Lateral Sclerosis hospitalized in the ALS unit at ICS Maugeri IRCCS, Milan.
Key inclusion criteria (11 listed)
- ---
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The SUS (System Usability Scale) assessment is conducted after each experimental session.
Time frame: up to 24 weeks
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).
The QUIS (Questionnaire for User Interaction Satisfaction) assessment is conducted after each experimental session.
Time frame: up to 24 weeks
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.
The NASA RTLX (NASA Raw Task Load Index) assessment is conducted after each experimental session.
Time frame: up to 24 weeks
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.
Change in perception of the robot (pre vs post interaction)
Time frame: up to 24 weeks
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.
Participants' subjective experience of interaction with Alter-Ego (qualitative)
Time frame: up to 24 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis and Health Adult Subjects, run by University of Pisa at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The SUS (System Usability Scale) assessment is conducted after each experimental session. (time frame: up to 24 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.