USABILITY OF A SOFT ROBOTIC DEVICE FOR THE SEVERELY IMPAIRED HAND AFTER STROKE

Ciullo AS1,2,3, Veerbeek JM4,5, Temperli E6, Luft AR4,5, Bicchi A1,3, Ajoudani A2, Catalano MG1, Held JPO4,7,8
1Italian Institute of Technology, Soft Robotics for Human Cooperation and Rehabilitation, Genoa, Italy, 2Italian Institute of Technology, Human-Robot Interfaces and Physical Interaction, Genoa, Italy, 3University of Pisa, Bioengineering and Robotics Research Center “E. Piaggio”, Pisa, Italy, 4University of Zurich and University Hospital Zurich, Division of Vascular Neurology and Neurorehabilitation, Department of Neurology, Zürich, Switzerland, 5cereneo, Center for Neurology and Rehabilitation, Vitznau, Switzerland, 6Zürcher RehaZentrum Wald, Department of Physiotherapy, Wald, Switzerland, 7Cereneo, Center for Neurology and Rehabilitation, Vitznau, Switzerland, 8University of Twente, Biomedical Signals and Systems, MIRA – Institute for Biomedical Technology and Technical Medicine, Enschede, Netherlands

Background: Hand and arm function are severely affected in 23% of the stroke patients [1]. These impairments hamper patients in performing upper limb activities in daily life, as these most often require using both hands [2]. Therefore, compensation devices are needed, such as a robotic device facilitating hand movements. This is challenging, as these systems are often difficult to attach to the body and difficult to control. To enable the use of the impaired hand, a new system has been developed, combining existing devices and new control mechanisms.

Purpose: The objective was to evaluate the usability of a soft robotic device to compensate hand movements in severely affected stroke patients.

Methods: In this usability study, chronic stroke patients (≥18 years) were enrolled who could not or minimally voluntarily flex/extend the fingers of the paretic side. During a single supervised session, patients tested a new soft robotic device, the SoftHand X [3]. It is configured as a robotic extra-limb, combining the Pisa/IIT SoftHand [4] and the SaeboMAS® and is controlled by different input sensors: (1) grasp force - impaired hand, (2) bending - middle finger, non impaired side, and (3) handheld - non-impaired hand. Patient's performance of object manipulation with the robotic extra-limb was evaluated by a modified version of the Action Research Arm Test (mARAT; score range 0-30). The mARAT included the scoring from 0 = cannot manipulate the object, 1 = able to lift the object, 2 = able to lift and position the object with several attempts; 3 = able to lift and position the object in the first attempt. In a subsequent interview, the usability was assessed using the System Usability Scale (SUS; score range 0-100) [5]. The participants gave written informed consent in accordance with the declaration of Helsinki. The study was approved by the Cantonal Ethics Committee Zurich, Switzerland (Req-2017-00972). Numbers are presented as median (interquartile range).

Results: Ten stroke patients (66, 52-70 years old, 31.5, 17.5-98.8 months poststroke) with severe upper limb motor impairment (Fugl-Meyer Assessment - Upper Extremity 14.5, 11.5-16) were included. Data from one patient was excluded, because of technical issues. In the SUS, patients scored “good” (82.5, 70.6-86.9) for controlling the system with the handheld controller, and “ok” for both the force (75, 63.8-77.5) and bending sensor (72.5, 51.3-75). Nine out of ten stroke patients stated in the SUS, that they would use the SoftHand X frequently. The performance checklist revealed that the most difficult tasks to execute in the mARAT were the 1cm marble and the 10cm wooden block.

Conclusion(s): Severely affected stroke patients were able to control the SoftHand X, although small and big objects were more difficult to manipulate.

Implications: The SoftHand X has the potential to compensate a severely impaired hand function in stroke patients, allowing them to perform bimanual activities. The feasibility of using this soft robotic device, including its different control sensors, in the clinic as well as in daily life should be investigated.

Keywords: Robotic, Upper Limb, Stroke

Funding acknowledgements: This project received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No. 688857 (SoftPro).

Topic: Robotics & technology; Neurology: stroke; Neurology

Ethics approval required: Yes
Institution: Cantonal Ethics Committee Zurich
Ethics committee: Cantonal Ethics Committee Zurich
Ethics number: Req-2017-00972


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