About this trial
The goal of this mixed method study is to learn about how a dynamic arm support device (DAS) helps people with everyday activities. The study focuses on people with neuro(-muscular) conditions, age 16 and older. The research questions that are formulated, are:
* How does a person experience their daily activities, with and without a DAS? * What are the contextual (external and personal) factors that influence the use of a DAS?
Participants will take part in three testing sessions. In each session, they must complete a few questionnaires and participate in an interview. The first time, without DAS. In the second and third session, they will be using their DAS (resp. 3 to 4 weeks and 3 months). The data collection will be executed by phone, digital questionnaires and/or paper.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 16 and oler
Being able to understand and comprehend test instructions
Using a DAS from Focal Meditech (Balancer, Flowing, Dowing, Gowing 2 or Top Help)
Disqualifiers
None
Trial population
The study population consists of individuals with a neuro(-muscular) or neurological condition who want to use a DAS, and who, after approval of a healthcare provider, also use a DAS.
Trial design
Cohort
Prospective
Treatments tested in this trial
Dynamic arm support
DeviceThe participant will receive a new dynamic arm support.
Treatment groups
Trial outcomes
Primary outcomes
Canadian Occupational Performance Measure (COPM)
The COPM is a semi-structured interview, where the participants give at least 5 activities of daily life. They give a score of satisfaction and performance (between 1 and 10) on these 5 activities.
Psychosocial impact of assistive devices scale (PIADS)
The psychosocial impact of assistive devices scale is a 26-item, self-report questionnaire designed to assess the effects of an assistive device (the DAS) on functional independence, well-being, and quality of life. Scores on competence (between -3 and +3), adaptability (between -3 and +3) and self-esteem (between -3 and +3).
Secondary outcomes
Visual Analogue Scale (VAS) - pain
The experienced pain, indicated on a VAS scale, between 0 and 10.
The Flow State Scale for Occupational Tasks (FSSOT)
The Flow State Scale for Occupational Tasks measures flow experiences during an activity with or without a dynamic arm support (DAS). Scores between 0 and 98.
Diary
During a period of 24 hours, participants fill out a diary in which they indicate how often and for what purposes they use their dynamic arm support (DAS).
Caregiver Assistive Technology Outcome Measure (CATOM)
The caregiver Assistive Technology Outcome Measure measures the caregiver's perception of the impacts of dynamic arm support in his or her life. Scores between 18 and 90.
Sponsors and contacts
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Hasselt University
Lead sponsor
Focal Meditech BV
Collaborator