Evidence map›Paper›PMID 38696428›Full record

ArticlePloS one2024

A patient-centered 'test-drive' strategy for ankle-foot orthosis prescription: Protocol for a randomized participant-blinded trial.

Benjamin R Shuman, Brad D Hendershot, David C Morgenroth, Elizabeth Russell Esposito

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06113159 ([Trial of device that is not approved or cleared by the U.S. FDA]), 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.

NCT06113159 withheldnot on this map

[Trial of device that is not approved or cleared by the U.S. FDA]

Typen_aSponsor[Redacted]
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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.

Benjamin R ShumanVA RR&D Center for Limb Loss and Mobility, VA Puget Sound Health Care System, Seattle, Washington, United States of America.ORCID 0000-0002-6976-8021
Brad D HendershotExtremity Trauma and Amputation Center of Excellence, Defense Health Agency, Falls Church, Virginia, United States of America.
David C MorgenrothVA RR&D Center for Limb Loss and Mobility, VA Puget Sound Health Care System, Seattle, Washington, United States of America.
Elizabeth Russell EspositoVA RR&D Center for Limb Loss and Mobility, VA Puget Sound Health Care System, Seattle, Washington, United States of America.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnkle-foot orthoses (AFOs) are commonly used to overcome mobility limitations related to lower limb musculoskeletal injury. Despite a multitude of AFOs to choose from, there is scant evidence to guide AFO prescription and limited opportunities for AFO users to provide experiential input during the process. To address these limitations in the current prescription process, this study evaluates a novel, user-centered and personalized 'test-drive' strategy using a robotic exoskeleton ('AFO emulator') to emulate commercial AFO mechanical properties (i.e., stiffness). The study will determine if brief, in-lab trials (with emulated or actual AFOs) can predict longer term preference, satisfaction, and mobility outcomes after community trials (with the actual AFOs). Secondarily, it will compare the in-lab experience of walking between actual vs. emulated AFOs. METHODS AND ANALYSIS: In this participant-blinded, randomized crossover study we will recruit up to fifty-eight individuals with lower limb musculoskeletal injuries who currently use an AFO. Participants will walk on a treadmill with three actual AFOs and corresponding emulated AFOs for the "in-lab" assessments. For the community trial assessment, participants will wear each of the actual AFOs for a two-week period during activities of daily living. Performance-based and user-reported measures of preference and mobility will be compared between short- and long-term trials (i.e., in-lab vs. two-week community trials), and between in-lab trials (emulated vs. actual AFOs).

trial registrationThe study was prospectively registered at www.clininicaltrials.gov (Clinical Trials Study ID: NCT06113159). Date: November 1st 2023. https://classic.clinicaltrials.gov/ct2/show/NCT06113159.

Indexed as

Foot OrthosesAdultAnkleCross-Over StudiesExoskeleton DeviceFemaleHumansMaleMiddle AgedRandomized Controlled Trials as TopicWalking

Identifiers

PMID38696428
PMCPMC11065291

What Socratic 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 Socratic graph.