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Evaluation of the ROBINA system regarding usability, acceptance and appropriateness. ROBINA endevaluation.

Evaluation of the ROBINA system regarding usability, acceptance and appropriateness. ROBINA endevaluation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00016554
Enrollment
24
Registered
2020-01-07
Start date
2020-01-12
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G12

Interventions

Group 1: In the course of the two and a half hour laboratory study, an assistive robot will be used to investigate human-robot interaction. Eye, joystick, head, muscle and touch controls are available

Sponsors

Charité - Universitätsmedizin Berlin, Forschungsgruppe Geriatrie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (a) ALS patients Inclusion criteria: - Patients over 18 years of age - Clinical diagnosis of an ALS (possible, probable or confirmed ALS according to the revised El Escorial criteria) - at least n=5 patients with at least a slight motor impairment of the arm function or manual function - accompanied by a person familiar with and/or involved in the care of the ALS patient (presence during the entire test procedure) - Maintain head and neck mobility - Especially for the "drinking assistance" application scenario - maintain swallowing ability, maintain coughing ability (c) informal cargeivers Inclusion criteria: - Completion of 18 years of age - Persons who have a close personal relationship with the patient, come from this family or extended environment and are significantly involved in the care. (d) professional caregivers Inclusion criteria: - Completion of 18 years of age - Training as a nurse or nursing assistant - Experience with the care of ALS patients

Exclusion criteria

Exclusion criteria: (a) ALS patients: - Test persons with existing skin injuries in the area of the arms, in order not to injure pre-damaged skin with the brush in the scenario "itching" - non-existent ability to give consent (accompanying at least moderate dementia) - unwillingness to store and pass on pseudonymised personal and disease-related data - Severe auditory, visual, sensory and motor impairments - Psychiatric diseases (e.g. depression, anxiety and compulsions; substance-related diseases in the last 2 years, schizophrenia, other psychotic diseases) - Severe affective or cognitive disorders (are or have you been treated for a mental illness?) (b) Accompanying persons: Exclusion criteria: - non-existent ability to consent - Existence of significant psychological stress, which from a clinical point of view makes the additional stress of questioning appear unreasonable. (c) informal caregivers: Exclusion criteria: - non-existent ability to consent - Existence of significant psychological stress, which from a clinical point of view makes the additional stress of questioning appear unreasonable. (d) formal caregivers: exclusion criteria: - Lack of experience in caring for ALS patients

Design outcomes

Primary

MeasureTime frame
ALS patients: Tests: - Basic data (age, gender, ALS diagnosis) (self-developed) + parts of ALS Functional Rating Scale (ALS-FRS-EX, validated, Abdulla S et al., 2013) - Acceptance of the system and Almere Model (Heerink, 2010) - Usability of the system (System Usability Scale, SUS, validated, Bangor et al., 2008) - cognitive and physical stress caused by human-robot interaction (NASA Task Load Index, validated, YM Xiao et al., 2005) - Need-based system and scenarios - Sustainability of the system and the scenarios Caregivers: Caregivers are asked to answer a questionnaire on caregiver stress (Zarit et al. 1980; Braun et al. 2010; Burke et al. 2015).

Secondary

MeasureTime frame
Interviews before the tests: - Subjective impression of the robot arm - Users' expectations of the robotic system - Assessment of the respondents about potential assistance/services - Self/foreign assessment of possible extent of handling of robotic systems by ALS patients - Ethical, legal and social aspects - Reasons for participating in the test / declaration of readiness - Sociodemographic characteristics Interviews after the tests: - Reflection on the practical experience of the test situation - Description of the experience of human-robot interaction during testing, in particular user-friendliness, barriers and possible solutions. - Comparison between previous videos and the actual testing of the robotic system - Projection/transfer to everyday caregiving life - future expectations - Ethical, legal and social aspects - Evaluation of ethical topics (according to MEESTAR model dimensions) - Further ethical and social challenges

Countries

Germany

Contacts

Public ContactCornelia Eicher

Charité, Universitätsmedizin Berlin, Forschungsgruppe Geriatrie

cornelia.eicher@charite.de030450553345

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026