Therapeutic Effect of a Soft Robotic Glove for Activities of Daily Living In People With Impaired Hand Strength: Protocol for a Multicenter Clinical Trial (iHand)

Anke Ida Roza Kottink; Corien Dm Nikamp; Foskea P Bos; Corry K van der Sluis; Marieke van den Broek; Bram Onneweer; Janneke M Stolwijk-Swüste; Sander M Brink; Nicoline Bm Voet; Jacob B Buurke; Johannes S Rietman; Gerdienke B Prange-Lasonder

doi:10.2196/34200

Therapeutic Effect of a Soft Robotic Glove for Activities of Daily Living In People With Impaired Hand Strength: Protocol for a Multicenter Clinical Trial (iHand)

JMIR Res Protoc. 2022 Apr 5;11(4):e34200. doi: 10.2196/34200.

Authors

Anke Ida Roza Kottink^#^{1

2}, Corien Dm Nikamp^#^{1

3}, Foskea P Bos⁴, Corry K van der Sluis⁵, Marieke van den Broek⁶, Bram Onneweer^{7

8}, Janneke M Stolwijk-Swüste^{9

10}, Sander M Brink¹¹, Nicoline Bm Voet^{12

13}, Jacob B Buurke^{1

3}, Johannes S Rietman^{1

2

14}, Gerdienke B Prange-Lasonder^{1

2}

Affiliations

¹ Roessingh Research and Development, Enschede, Netherlands.
² Department of Biomechanical Engineering, University of Twente, Enschede, Netherlands.
³ Department of Biomedical Signals and Systems, University of Twente, Enschede, Netherlands.
⁴ Reade, Amsterdam, Netherlands.
⁵ University of Groningen, University Medical Center Groningen, Department of Rehabilitation Medicine, Groningen, Netherlands.
⁶ Sint Maartenskliniek, Ubbergen, Netherlands.
⁷ Rijndam Rehabilitation, Rotterdam, Netherlands.
⁸ Department of Rehabilitation Medicine, Erasmus MC, Rotterdam, Netherlands.
⁹ De Hoogstraat Rehabilitation, Utrecht, Netherlands.
¹⁰ Centre of Excellence for Rehabilitation Medicine, Brain Centre Rudolf Magnus, University Medical Centre Utrecht, Utrecht, Netherlands.
¹¹ Department of Rehabilitation Medicine, Isala, Zwolle, Netherlands.
¹² Rehabilitation center Klimmendaal, Arnhem, Netherlands.
¹³ Department of Rehabilitation, Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Nijmegen, Netherlands.
¹⁴ Roessingh Center for Rehabilitation, Enschede, Netherlands.

^# Contributed equally.

PMID: 35380115
PMCID: PMC9019626
DOI: 10.2196/34200

Abstract

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.

Keywords: activities of daily living; assist; assistive technology; function; hand; hand function; hand strength; intervention; protocol; rehabilitation; robot; robotics; soft-robotic glove; support; therapy; upper extremity; wearable; wearable devices.

©Anke Ida Roza Kottink, Corien DM Nikamp, Foskea P Bos, Corry K van der Sluis, Marieke van den Broek, Bram Onneweer, Janneke M Stolwijk-Swüste, Sander M Brink, Nicoline BM Voet, Jacob B Buurke, Johannes S Rietman, Gerdienke B Prange-Lasonder. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 05.04.2022.