Evidence map›Paper›PMID 37983080›Full record

ArticleJMIR rehabilitation and assistive technologies2023

Validating the Safe and Effective Use of a Neurorehabilitation System (InTandem) to Improve Walking in the Chronic Stroke Population: Usability Study.

Kirsten Elisabeth Smayda, Sarah Hodsdon Cooper, Katie Leyden, Jackie Ulaszek, Nicole Ferko, Annamaria Dobrin

Erratum issuedOpen access · goldAbstract read
In one paragraph

Article in JMIR rehabilitation and assistive technologies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 28% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. Sensory Entrained TMS (seTMS) enhances motor cortex plasticity.bioRxiv : the preprint server for biology · 2025
    Article
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 2 institutions in 2 countries.

Kirsten Elisabeth Smayda *MedRhythms, Portland, ME, United States.ORCID 0000-0001-7017-9390
Sarah Hodsdon Cooper *MedRhythms, Portland, ME, United States.ORCID 0000-0002-2375-6586
Katie LeydenBold Insight, Downers Grove, IL, United States.ORCID 0009-0003-5164-595X
Jackie UlaszekBold Insight, Downers Grove, IL, United States.ORCID 0009-0000-0946-0722
Nicole FerkoEversana, Burlington, ON, Canada.ORCID 0000-0002-7099-7075
Annamaria DobrinEversana, Burlington, ON, Canada.ORCID 0009-0008-9368-2851
EVERSANA (Canada) · CAMaineHealth · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPersistent walking impairment following a stroke is common. Although rehabilitative interventions exist, few exist for use at home in the chronic phase of stroke recovery. InTandem (MedRhythms, Inc) is a neurorehabilitation system intended to improve walking and community ambulation in adults with chronic stroke walking impairment.

objectiveUsing design best practices and human factors engineering principles, the research presented here was conducted to validate the safe and effective use of InTandem.

methodsIn total, 15 participants in the chronic phase of stroke recovery (≥6 months after stroke) participated in this validation study. Participants were scored on 8 simulated use tasks, 4 knowledge assessments, and 7 comprehension assessments in a simulated home environment. The number and types of use errors, close calls, and operational difficulties were evaluated. Analyses of task performances, participant behaviors, and follow-up interviews were conducted to determine the root cause of use errors and difficulties.

resultsDuring this validation study, 93% (14/15) of participants were able to successfully complete the critical tasks associated with the simulated use of the InTandem system. Following simulated use task assessments, participants' knowledge and comprehension of the instructions for use and key safety information were evaluated. Overall, participants were able to find and correctly interpret information in the materials in order to answer the knowledge assessment questions. During the comprehension assessment, participants understood warning statements associated with critical tasks presented in the instructions for use. Across the entire study, 3 "use errors" and 1 "success with difficulty" were recorded. No adverse events, including slips, trips, or falls, occurred in this study.

conclusionsIn this validation study, people in the chronic phase of stroke recovery were able to safely and effectively use InTandem in the intended use environment. This validation study contributes to the overall understanding of residual use-related risks of InTandem in consideration of the established benefits.

Indexed as

chronic strokehuman factors engineeringInTandemMR-001neurorehabilitationneurotherapeuticrhythmic auditory stimulationusabilityvalidationwalking

Identifiers

PMID37983080
PMCPMC10696501
OpenAlexW4388837328

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.