Arm Use With Soft-robotic Glove

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorRoessingh Research and Development

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 volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Carbonhand

    Device

    During 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

5 Participants
are divided into 3 treatment groups
Group A: Baseline phaseNo intervention 0 interventions
Group B: Soft-robotic glove phaseExperimental treatment 1 intervention
Group C: Retention phaseNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases), while wearing the MotionWatch for a day during waking hours (ca. 12h).

Secondary outcomes

1

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.

Time frame
During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases), with supervision by researcher on videocall
2

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.

Time frame
During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases)
3

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.

Time frame
During home assessments: 15 times scheduled intermittently across 12-14 weeks (5x in each of the three study phases)
4

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).

Time frame
Continuously and automatically during soft-robotic glove use phase (6 weeks) when soft-robotic glove is turned on and activated.

Other outcomes

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