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
This trial does not accept healthy volunteersQualifiers
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
Crossover
Treatments tested in this trial
Carbonhand
DeviceDuring this phase, participants use the Carbonhand soft-robotic glove system in daily life for 6 weeks to support the performance of daily activities with their affected hand in the home environment. The participants are free to choose for which activities, when and for how long they use the Carbonhand. However, it is recommended to use the Carbonhand at least 180 minutes a week during the most common ADL, such as household activities, dressing/undressing, eating/drinking/cooking, and/or leisure activities.
Treatment groups
Trial outcomes
Primary outcomes
Actual arm activity
The main study parameter is actual arm use as measured by two MotionWatch8 devices, containing an accelerometer, one around each wrist. In essence, the 'raw' accelerometer signal will be transformed into an 'activity count signal'. Actual amount of arm-hand use will then be calculated in several ways, focusing on the duration of use and the intensity of use of the affected arm-hand.
Secondary outcomes
Grip strength
The maximal handgrip strength will be measured with a Jamar dynamometer (Patterson medical, Warrenville, IL, USA), in accordance with American Society of Hand Therapist guidelines. Each participant is sitting comfortably with the elbow of the affected arm close to their body, flexed 90 degrees, holding the dynamometer in the affected hand. The other parts of the body is not allowed to move or help to give more strength. The participant has to squeeze the handgrip of the dynamometer maximally for 5 seconds. There will be three attempts and between the different attempts are at least 60 seconds rest. The best of the three attempts will count.
Michigan Hand Outcomes Questionnaire - Question 2 (MHQ-Q2)
The original MHQ (total of 57 items) asks a patient's opinion about his hands and his health. This list is used to find out how the patient feels and to what extent he is capable of carrying out daily activities. The problem is mapped out within 6 domains: total hand function, ADL, work situation, work performance, pain, aesthetics and satisfaction. For repeated home assessment, we only ask question 2 A/B (most affected right or left hand) and 2 C (bimanual activities) of the domain ADL. This item consists of a total of 12 statements to rate on a 5-points Likert scale. The scores are normalized afterwards to a range of 0 to 100.
Positive Health questionnaire
Huber et al. studied how people think about health. They concluded that the concept of health no longer fits within the definition of the World Health Organization (health as complete wellbeing and absence of disease). The Institute for Positive Health created a tool to gain insight into the positive health of a person. This tool consists of 6 dimensions: bodily functions, mental wellbeing, meaningfulness, quality of life, participation, and daily functioning. Participants complete the questionnaire, resulting in a score between 0 and 10 for each dimension \[19\]. In our study, an adapted version will be used. Instead of completing a questionnaire consisting of 42 questions, the participants score each of the six dimensions from 0 to 10, as reported by van Velsen et al.
Glove use data
During the intervention phase, glove use time will be automatically recorded in the Carbonhand system, representing objective, cumulative duration of glove activation (recording is stopped after 2 min of inactivity).
Sponsors and contacts
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Roessingh Research and Development
Lead sponsor
Eurostars
Collaborator