Evidence map›Paper›PMID 28533700›Full record

ReviewMedical devices (Auckland, N.Z.)2017

Risk management and regulations for lower limb medical exoskeletons: a review.

Yongtian He, David Eguren, Trieu Phat Luu, Jose L Contreras-Vidal

Registry-linked trialAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Medical devices (Auckland, N.Z.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03986320 (A Multi-site, Interventional, Comparative, Single-arm Trial to Evaluate the Safety and Effectiveness of Keeogo™ Dermoskeleton in Subjects With Hemiparesis Due to Ischemic or Hemorrhagic Stroke.), which is not on this map. Cited by 50 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 6 pooled it
–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.

NCT03986320 naunknown statusnot on this mapstarted 2019, after this paper: background citation

A Multi-site, Interventional, Comparative, Single-arm Trial to Evaluate the Safety and Effectiveness of Keeogo™ Dermoskeleton in Subjects With Hemiparesis Due to Ischemic or Hemorrhagic Stroke.

TypeinterventionalSponsorB-Temia, Inc.Ran2019 to 2020Enrolled60ConditionsStroke, Ischemic, Stroke Hemorrhagic, Stroke, HemiparesisArmsKeeogo™ Dermoskeleton
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Relevance of hazards in exoskeleton applications: a survey-based enquiry.Journal of neuroengineering and rehabilitation · 2023
    Article
  18. Overview of the role of robots in upper limb disabilities rehabilitation: a scoping review.Archives of public health = Archives belges de sante publique · 2023
    Article
  19. Article
  20. 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

4 authors.

Yongtian HeLaboratory for Noninvasive, Brain-Machine Interface Systems, Department of Electrical and Computer Engineering, University of Houston, Houston, TX, USA.
David EgurenLaboratory for Noninvasive, Brain-Machine Interface Systems, Department of Electrical and Computer Engineering, University of Houston, Houston, TX, USA.
Trieu Phat LuuLaboratory for Noninvasive, Brain-Machine Interface Systems, Department of Electrical and Computer Engineering, University of Houston, Houston, TX, USA.
Jose L Contreras-VidalLaboratory for Noninvasive, Brain-Machine Interface Systems, Department of Electrical and Computer Engineering, University of Houston, Houston, TX, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Gait disability is a major health care problem worldwide. Powered exoskeletons have recently emerged as devices that can enable users with gait disabilities to ambulate in an upright posture, and potentially bring other clinical benefits. In 2014, the US Food and Drug Administration approved marketing of the ReWalk™ Personal Exoskeleton as a class II medical device with special controls. Since then, Indego™ and Ekso™ have also received regulatory approval. With similar trends worldwide, this industry is likely to grow rapidly. On the other hand, the regulatory science of powered exoskeletons is still developing. The type and extent of probable risks of these devices are yet to be understood, and industry standards are yet to be developed. To address this gap, Manufacturer and User Facility Device Experience, Clinicaltrials.gov, and PubMed databases were searched for reports of adverse events and inclusion and exclusion criteria involving the use of lower limb powered exoskeletons. Current inclusion and exclusion criteria, which can determine probable risks, were found to be diverse. Reported adverse events and identified risks of current devices are also wide-ranging. In light of these findings, current regulations, standards, and regulatory procedures for medical device applications in the USA, Europe, and Japan were also compared. There is a need to raise awareness of probable risks associated with the use of powered exoskeletons and to develop adequate countermeasures, standards, and regulations for these human-machine systems. With appropriate risk mitigation strategies, adequate standards, comprehensive reporting of adverse events, and regulatory oversight, powered exoskeletons may one day allow individuals with gait disabilities to safely and independently ambulate.

Indexed as

EksoFDAHALIndegoReWalkRex

Identifiers

PMID28533700
PMCPMC5431736

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.