Requirements analysis for a robotic assistive system to support and promote the autonomy of people with neuromuscular diseases
- Conditions
- G12.2Motor neuron disease
- Registration Number
- DRKS00022534
- Lead Sponsor
- Forschungsgruppe Geriatrie - Charité Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
(a) patients with NME
- Patients from the age of 18 years
- Clinical diagnosis of a NME: possible, probable or confirmed ALS according to the revised elescorial criteria or clinically confirmed diagnosis of an infantile or juvenile form of spinal muscular atrophy (type I, II and III)
- already supplied with a robotic system
b) (nursing) relatives
- at the age of 18 years
- Persons who have a close personal relationship with the patient, come from the patient's family or extended environment and are significantly involved in the care process
c) Nursing professionals
- at the age of 18 years
- registered carer or care assistant
- Experience with the care of people with NME
(a) patients with MNE
- lack of ability to consent (concomitant at least moderate dementia)
- unwillingness to record pseudonymised personal and disease-related data
- Severe auditory, visual, sensory and motor limitations
- Psychiatric disorders (e.g. depression, anxiety and compulsions; substance-related disorders in the last 2 years, schizophrenia, other psychotic disorders)
- Severe affective or cognitive disorders (Are you or have you been treated for a mental illness?)
- No testing of or provision of robotic assistance system(s)
b) (nursing) relatives
- absence of consent
- Existence of a significant psychological burden which makes the additional burden of interviewing appear unreasonable from a clinical point of view
c) Nursing professionals
- Lack of experience with the care of ALS patients
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method What are the requirements of MNE patients and their (informal) caregivers on robotic assistive systems for maintaining autonomy and coping with everyday life?<br>By using semi-structured interviews the following fields will be examined:<br>- Fields of application of robotic systems to support people with MNE in everyday life<br>- Robustness of human-robot interaction (HRI)<br>- Perception and acceptance of the automation process of action <br>- Cognitive and physical stress from human-robot interaction<br>- Impact of HRI on the quality of life of both patients and (informal/professional) caregivers<br>- Relief from robotic support<br>In addition, moderating factors such as willingness to use technology, self-efficacy and quality of life will be assessed on the basis of validated, quantitative questionnaires.<br><br><br>
- Secondary Outcome Measures
Name Time Method Which empirical challenges exist with regard to the user group-specific requirements about ethical dimensions of participation, care, self-determination, security, privacy, justice and self-image?<br>By using semi-structured interviews the following fields will be examined:<br>- Identification of ethical challenges for the future routine clinical use of assistive robotics for people with neuromuscular diseases<br>- Empirical evidence for the risk-benefit calculation with regard to the ethical assessment dimensions of participation, care, self-determination, safety, privacy, justice and self-image for the future routine use of robotic assistants for people with neuromuscular diseases.<br>- Definition of ethical recommendations for the future routine clinical use of robotic assistants for people with neuromuscular diseases.