Background Decline of hand function, especially reduced hand strength, is a common problem that can be caused by many disorders and results in difficulties performing activities of daily living. A wearable soft robotic glove may be a solution, enabling use of the affected arm and hand repeatedly during functional daily activities and providing intensive and task-specific training simultaneously with assistance of hand function. Objective We aim to investigate the therapeutic effect of an assistive soft robotic glove (Carbonhand). Methods This multicenter uncontrolled intervention study consists of 3 preassessments (T0, T1, and T2), a postassessment (T3), and a follow-up assessment (T4). Participants are patients who experience hand function limitations. For the intervention, participants will use the glove during activities of daily living at home for 6 weeks, with a recommended use of at least 180 minutes per week. The primary outcome measure is handgrip strength, and secondary outcome measures are related to functional arm and hand abilities, amount of glove use, and quality of life. Results The first participant was included on June 25, 2019. Currently, the study has been extended due to the COVID-19 pandemic; data collection and analysis are expected to be completed in 2022. Conclusions The Carbonhand system is a wearable assistive device, allowing performance of functional activities to be enhanced directly during functional daily activities. At the same time, active movement of the user is encouraged as much as possible, which has potential to provide highly intensive and task-specific training. As such, it is one of the first assistive devices to incorporate assist-as-needed principles. This is the first powered clinical trial that investigates the unique application of an assistive grip-supporting soft robotic glove outside of clinical settings with the aim to have a therapeutic effect. Trial Registration Netherlands Trial Register NTR NL7561; https://www.trialregister.nl/trial/7561 International Registered Report Identifier (IRRID) DERR1-10.2196/34200

In an ongoing study, an assistive wearable softrobotic glove is tested at home for 6 weeks by subjects with decreased handgrip strength, due to different hand injuries or diseases, to assess whether use of this assistive grip-supporting glove will result in improved hand strength/ function. An interim analysis of the available dataset of 46 participants showed that (unsupported) grip strength and hand function improved after using the soft-robotic glove as assistive aid during activities of daily living (ADLs) during 6 weeks at home. After glove use is ended, this is maintained for at least 4 weeks. Considering that in the current situation the analysis is underpowered, these interim results are promising for finding a clinical (therapeutic) effect of using a soft-robotic glove as assistance during ADLs. If this is the case, this might open up entirely new opportunities for extending rehabilitation into people's homes, while also providing them with assistance to directly support performance of daily activities. Such a combination is becoming available with the development of mature and user-friendly wearable softrobotic devices. This would enable very high doses of training throughout the day, in the most functional, task-specific way possible, and possibly prevention of learned non-use.

In this ongoing study, an assistive wearable soft-robotic glove, named Carbonhand, is tested at home for 6 weeks by subjects with decreased handgrip strength to receive a first insight in the therapeutic effect of using this assistive gripsupporting glove during ADLs. Preliminary results of the first 13 participants showed that participants appreciated use of the glove to assist them with daily life activities. Even more, grip strength without glove improved and functional performance showed increases as well. These preliminary findings hold promise for observing a clinical effect of using the soft-robotic glove as assistance in ADLs upon completion of data collection.

BACKGROUND Decline of hand function, especially reduced hand strength, is a common problem amongst many disorders, resulting in difficulties to perform activities of daily living (ADLs). A wearable soft-robotic glove may be a possible solution, enabling use of the affected arm and hand repeatedly during functional daily activities, and providing intensive and task-specific training simultaneously with assistance of hand function. OBJECTIVE The current multi-center uncontrolled intervention study aims to investigate the therapeutic effect of an assistive soft-robotic glove (Carbonhand). METHODS The study design consists of three pre-assessments (T0, T1 and T2), a post-assessment (T3) and a follow-up assessment (T4). Participants are patients who experience hand function limitations, which can result from a wide range of chronic disorders. As intervention, all participants will use the Carbonhand glove during ADLs at home for six weeks, with a recommended use of at least 180 minutes/week. The primary outcome measure is handgrip strength and secondary outcome measures are related to arm and hand function, functional arm and hand abilities, amount of glove use and quality of life. RESULTS The first participant was included on the 25th of June 2019. Currently, the iHand study is extended because of the COVID-19 pandemic and data collection and analysis are expected to be completed in 2022. CONCLUSIONS The Carbonhand system is a wearable assistive device, allowing performance of functional activities to be enhanced directly during functional daily activities. At the same time, active movement of the user is encouraged as much as possible, which has potential to provide highly intensive and task-specific training. As such it is one of the first assistive devices incorporating assist-as-needed principles. This is the first powered clinical trial that investigates the unique application of an assistive grip-supporting soft-robotic glove outside of the clinical setting with the aim to have a therapeutic effect. CLINICALTRIAL The iHand study was prospectively registered on March 4th 2019 in the Netherlands Trial Register: NTR NL7561 (www.trialregister.nl/7561).