Evidence map›Paper›PMID 39391753›Full record

ArticleFrontiers in neuroscience2024

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.

Franziska Nadorf, Mark Andrew Wright, Helena López-Matas, Erika Porras, Alfons Carnicero-Carmona, Cornelia Hensel, Steffen Franz, Norbert Weidner, Joan Vidal, Eloy Opisso and 1 more

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in neuroscience, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05643313 (Clinical Investigation on Feasibility and Usability of the ABLE Exoskeleton Device for Individuals With Spinal Cord Injury to Perform Skills for Home and Community Environments), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05643313 nacompletednot on this map

Clinical Investigation on Feasibility and Usability of the ABLE Exoskeleton Device for Individuals With Spinal Cord Injury to Perform Skills for Home and Community Environments

TypeinterventionalSponsorABLE Human Motion S.L.Ran2022 to 2023Enrolled10ConditionsSpinal Cord InjuriesArmsABLE Exoskeleton
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Franziska Nadorf *Spinal Cord Injury Center, Heidelberg University Hospital, Heidelberg, Germany.
Mark Andrew Wright *Institut Guttmann, University Institute Attached to the Universitat Autònoma de Barcelona, Barcelona, Spain.
Helena López-MatasABLE Human Motion S.L., Barcelona, Spain.
Erika PorrasABLE Human Motion S.L., Barcelona, Spain.
Alfons Carnicero-CarmonaABLE Human Motion S.L., Barcelona, Spain.
Cornelia HenselSpinal Cord Injury Center, Heidelberg University Hospital, Heidelberg, Germany.
Steffen FranzSpinal Cord Injury Center, Heidelberg University Hospital, Heidelberg, Germany.
Norbert WeidnerSpinal Cord Injury Center, Heidelberg University Hospital, Heidelberg, Germany.
Joan VidalInstitut Guttmann, University Institute Attached to the Universitat Autònoma de Barcelona, Barcelona, Spain.
Eloy OpissoInstitut Guttmann, University Institute Attached to the Universitat Autònoma de Barcelona, Barcelona, Spain.
Rüdiger RuppSpinal Cord Injury Center, Heidelberg University Hospital, Heidelberg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 quasi-experimental 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, six 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 ( 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. Clinical trial registration: https://clinicaltrials.gov/study/NCT05643313.

Indexed as

exoskeletonfeasibilityhome and communitylower limbpersonal usespinal cord injuryusabilityuser-centered design

Identifiers

PMID39391753
PMCPMC11464447

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.