The iHand clinical trial protocol: the therapeutic effect of using a soft-robotic glove as assistive device to support people with impaired hand strength during activities of daily living (Preprint)

Abstract

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.

The current multi-center uncontrolled intervention study aims to investigate the therapeutic effect of an assistive soft-robotic glove (Carbonhand).

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.

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.

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.

The iHand study was prospectively registered on March 4th 2019 in the Netherlands Trial Register: NTR NL7561 (www.trialregister.nl/7561).