About this trial
This study, aimed at investigating the impact of using a supportive soft-robotic glove on actual arm and hand use in daily life, is designed as a single-case experimental design study. 3-5 patients with limitations in hand function due to trauma-related or neurological conditions are asked to participate. Participants will be asked to use a soft-robotic glove at home for six weeks during daily activities relevant to them, while that glove supports the grip of their most affected hand. For several weeks before, during and after the use of the soft-robotic glove, participants will be asked to do some short tests (wearing an activity meter on both wrists during the day, performing a hand squeeze test under the supervision of the researcher via video call) and to answer some questions related to perceived hand function and well-being (a total of at least 15 times during 12-14 weeks). The present study is a follow-up to previous studies that investigated the effect of (previous versions of) the same robotic glove (Carbonhand; Bioservo Technolo-gies AB, Kista, Sweden) on hand function, in order to better understand and explain the observed therapeutic effect.
Eligibility criteria
Qualifiers
Age between 18 and 90 years
Experience difficulties in performing ADL due to hand function limitations as a result of trauma-related injury or neurologic disorder
Being in a chronic/stable phase of disease as judged by their physician
Able to activate the soft-robotic glove by generating pressure on finger/palm sensors when grasping an object
Disqualifiers
Severe sensory problems of the most-affected hand
Severe acute pain of the most-affected hand
Wounds on the hands that can provide a problem when using the glove
Severe contractures limiting passive range of motion to the extent that the glove can't be donned/activated comfortably
Trial design
Treatments tested in this trial
- Carbonhand
Treatment groups
Sponsors and collaborators
Roessingh Research and Development
Lead sponsor
Eurostars
Collaborator