Alter-Ego as an Assistive Robotic Device.

NCT07572838 | Not Yet Recruiting

• 1 other identifier: CTSM155-24
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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) 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). 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.

Conditions

Amyotrophic Lateral Sclerosis; Health Adult Subjects

Keywords

Humanoid robotic platform; Assistive Device; Telemedicine; Healthcare

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  up to 24 weeks

Study Arms (2)

ALS patient

Healthcare Professionals

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Amyotrophic Lateral Sclerosis hospitalized in the ALS unit at ICS Maugeri IRCCS, Milan.

You may qualify if:

• 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
• 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.
• \---

You may not qualify if:

• Healthcare Professionals
• \. 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.

Sponsors & Collaborators

• University of Pisa: lead
• Istituti Clinici Scientifici Maugeri SpA: collaborator

Study Sites (1)

Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute

Milan, Milan, 20138, Italy

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Antonio Bicchi

CONTACT

+39 3395880797; antonio.bicchi@unipi.it

Manuel G. Catalano

CONTACT

+39 3286158668; manuel.catalano@iit.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

IT (1)