G12
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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
Charité, Universitätsmedizin Berlin, Forschungsgruppe Geriatrie