Evidence map›Paper›PMID 29414988›Full record

Trial reportPloS one2018

Laboratory- and community-based health outcomes in people with transtibial amputation using crossover and energy-storing prosthetic feet: A randomized crossover trial.

Sara J Morgan, Cody L McDonald, Elizabeth G Halsne, Sarah M Cheever, Rana Salem, Patricia A Kramer, Brian J Hafner

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
2.0field-weighted citation impact, top 14% 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.

NCT02440711 nacompletednot on this map

Endurance, Energy Expenditure, Perceived Function, and Satisfaction of Persons With Transtibial Limb Loss Using a Running-Specific Prosthesis Modified for Walking

TypeinterventionalSponsorUniversity of WashingtonRan2015 to 2018Enrolled36ConditionsTranstibial AmputationArmsEnergy storing foot (ESF), Modified running specific foot (mRSF)
NCT05628064 nacompletednot on this mapstarted 2022, after this paper: background citation

Prospective, Feasibility Study to Evaluate Performance, Patient Benefits, and Acceptance of a New 1C70 Energy Storage and Return Prosthetic Foot

TypeinterventionalSponsorOtto Bock Healthcare Products GmbHRan2022 to 2023Enrolled22ConditionsAmputationArms1C70, Pro-Flex XC
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 30 citations in OpenAlex.

  1. Technology for monitoring everyday prosthesis use: a systematic review.Journal of neuroengineering and rehabilitation · 2020
    Pooled it
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  3. Trial
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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

7 authors at 1 institution in 1 country.

Sara J MorganDepartment of Rehabilitation Medicine, University of Washington, Seattle, WA, United States of America.
Cody L McDonaldDepartment of Rehabilitation Medicine, University of Washington, Seattle, WA, United States of America.
Elizabeth G HalsneDepartment of Rehabilitation Medicine, University of Washington, Seattle, WA, United States of America.
Sarah M CheeverDepartment of Rehabilitation Medicine, University of Washington, Seattle, WA, United States of America.
Rana SalemDepartment of Rehabilitation Medicine, University of Washington, Seattle, WA, United States of America.
Patricia A KramerDepartment of Anthropology, University of Washington, Seattle, WA, United States of America.
Brian J HafnerDepartment of Rehabilitation Medicine, University of Washington, Seattle, WA, United States of America.ORCID 0000-0001-6175-1869
University of Washington · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Contemporary prosthetic feet are generally optimized for either daily or high-level activities. Prosthesis users, therefore, often require multiple prostheses to participate in activities that span a range of mobility. Crossover feet (XF) are designed to increase the range of activities that can be performed with a single prosthesis. However, little evidence exists to guide clinical prescription of XF relative to traditional energy storing feet (ESF). The objective of this study was to assess the effects of XF and ESF on health outcomes in people with transtibial amputation. A randomized crossover study was conducted to assess changes in laboratory-based (endurance, perceived exertion, walking performance) and community-based (step activity and self-reported mobility, fatigue, balance confidence, activity restrictions, and satisfaction) outcomes. Twenty-seven participants were fit with XF and ESF prostheses with standardized sockets, interfaces, and suspensions. Participants were not blinded to the intervention, and wore each prosthesis for one month while their steps were counted with an activity monitor. After each accommodation period, participants returned for data collection. Endurance and perceived exertion were measured with the Six-Minute Walk Test and Borg-CR100, respectively. Walking performance was measured using an electronic walkway. Self-reported mobility, fatigue, balance confidence, activity restrictions, and satisfaction were measured with survey instruments. Participants also reported foot preferences upon conclusion of the study. Differences between feet were assessed with a crossover analysis. While using XF, users experienced improvements in most community-based outcomes, including mobility (p = .001), fatigue (p = .001), balance confidence (p = .005), activity restrictions (p = .002), and functional satisfaction (p < .001). Participants also exhibited longer sound side steps in XF compared to ESF (p < .001). Most participants (89%) reported an overall preference for XF; others (11%) reported no preference. Results indicate that XF may be a promising alternative to ESF for people with transtibial amputation who engage in a range of mobility activities.

trial registrationClinicalTrials.gov NCT02440711.

Indexed as

Amputation, SurgicalArtificial LimbsFootProstheses and ImplantsCross-Over StudiesHumansTibiaTreatment Outcome

Identifiers

PMID29414988
PMCPMC5802443
OpenAlexW2791891737

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.