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CLINICAL TRIAL article

Front. Neurosci.
Sec. Neuroprosthetics
Volume 18 - 2024 | doi: 10.3389/fnins.2024.1437358
This article is part of the Research Topic Exoskeleton Gait Training View all 5 articles

User-centered design of a Personal-use Exoskeleton: A Clinical Investigation on the Feasibility and Usability of the ABLE Exoskeleton device for individuals with spinal cord injury to perform skills for home and community environments

Provisionally accepted
Mark Wright Mark Wright 1*Franziska Nadorf Franziska Nadorf 2Helena López-Matas Helena López-Matas 3Erika Porras Erika Porras 3Alfons Carnicero-Carmona Alfons Carnicero-Carmona 3Cornelia Hensel Cornelia Hensel 2Steffen Franz Steffen Franz 2Norbert Weidner Norbert Weidner 2Joan Vidal Joan Vidal 1Eloy Opisso Eloy Opisso 1Ruediger Rupp Ruediger Rupp 2
  • 1 Guttmann Institute, Badalona, Spain
  • 2 Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany
  • 3 ABLE Human Motion, Barcelona, Catalonia, Spain

The final, formatted version of the article will be published soon.

    Introduction: The ABLE Exoskeleton has been tested to be safe and feasible for persons with spinal cord injury (SCI) to complete basic skills in clinical settings but has not been tested for use in home and community environments. A user-centered design process was employed to test the feasibility of the current ABLE Exoskeleton (designed for clinical use) for persons with SCI to perform the basic and advanced skills required for home and community environments, to gain crucial feedback for the development of a novel personal-use exoskeleton. Methods: In this prospective pretest-posttest quasiexperimental study across two SCI centers (Germany, Spain), in-and outpatients with SCI were included into a 22-session training and assessment protocol, utilizing the ABLE Exoskeleton. Feasibility and usability measures (level of assistance (LoA) for basic and advanced skills, donning/doffing-time and LoA) were recorded together with safety outcomes, and participant and therapist satisfaction with the device. Results: 10 participants (44.4 ± 24 years), with SCI from C5 to T11, (American Spinal Injury Association Impairment Scale A-D) completed the study. In 209 sessions, 6 device-related adverse events (pain and skin lesions) were reported. Average total time for don and doff was 10:23 ± 3:30 min. Eight participants were able to complete don and doff with minimal assistance or less. Independence to carry out all skills in the device increased significantly for all participants (p<0.05). Participants with chronic SCI required a significantly (p<0.05) lower LoA for 6 of the 9 advanced skills than those in the sub-acute phase. Discussion: This study shows that the ABLE Exoskeleton is safe, feasible and usable for people with SCI in respect to independent donning, doffing and performance of basic and advanced exoskeleton skills. The supervised exoskeleton use in the clinical environment was a highly valuable approach for identifying the challenging tasks and the necessary technological developments that need to be carried out for a personal-use exoskeleton, including a more independent sit-to-stand transition, faster speed of transitions between states and a richer display on the remote control for the user.Trial Registration: NCT05643313, retrospectively registered on November 25, 2022.

    Keywords: Spinal Cord Injury1, lower limb2, exoskeleton3, Feasibility4, usability5, personal use6, home and community7, user-centered design8

    Received: 23 May 2024; Accepted: 02 Sep 2024.

    Copyright: © 2024 Wright, Nadorf, López-Matas, Porras, Carnicero-Carmona, Hensel, Franz, Weidner, Vidal, Opisso and Rupp. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Mark Wright, Guttmann Institute, Badalona, Spain

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.