Evidence map›Paper›PMID 32991872›Full record

ArticleArchives of physical medicine and rehabilitation2021

Inaccurate Use of the Upper Extremity Fugl-Meyer Negatively Affects Upper Extremity Rehabilitation Trial Design: Findings From the ICARE Randomized Controlled Trial.

Shashwati Geed, Christianne J Lane, Monica A Nelsen, Steven L Wolf, Carolee J Winstein, Alexander W Dromerick

Open access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Archives of physical medicine and rehabilitation, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.2field-weighted citation impact, top 39% 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, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. 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

6 authors at 3 institutions in 1 country.

Shashwati GeedDepartment of Rehabilitation Medicine, Center for Brain Plasticity and Recovery, Georgetown University and MedStar National Rehabilitation Hospital, Washington, DC. Electronic address: sg1075@georgetown.edu.
Christianne J LaneDepartment of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA.
Monica A NelsenDivision of Biokinesiology and Physical Therapy, Herman Ostrow School of Dentistry, University of Southern California, Los Angeles, CA.
Steven L WolfDepartment of Rehabilitation Medicine, Division of Physical Therapy, Emory School of Medicine, Atlanta, GA; Department of Medicine, Emory School of Medicine, Atlanta, GA; Department of Cell Biology, Emory School of Medicine, Atlanta, GA; Center for Visual and Neurocognitive Rehabilitation, Atlanta VA Health Services, Decatur, GA.
Carolee J WinsteinDivision of Biokinesiology and Physical Therapy, Herman Ostrow School of Dentistry, Keck School of Medicine, University of Southern California, Los Angeles, CA; Department of Neurology, Keck School of Medicine, University of Southern California, Los Angeles, CA.
Alexander W DromerickDepartment of Rehabilitation Medicine, Center for Brain Plasticity and Recovery, Georgetown University and MedStar National Rehabilitation Hospital, Washington, DC; Department of Neurology, Center for Brain Plasticity and Recovery, Georgetown University and MedStar National Rehabilitation Hospital, Washington, DC.
University of Southern California · USMedStar National Rehabilitation Hospital · USEmory Healthcare · US

Funding

Interdisciplinary Comprehensive Arm Rehab Evaluation (I-CARE) Stroke InitiativeU01NS056256 · NINDS · UNIVERSITY OF SOUTHERN CALIFORNIA · PI DROMERICK, ALEXANDER W, WINSTEIN, CAROLEE J · 2008 to 2013
$12.7M
Translational Biomedical Science Training GrantTL1TR001431 · NCATS · GEORGETOWN UNIVERSITY · PI LEE, DEXTER L, SANDBERG, KATHRYN L · 2015 to 2024
$4.8M
Neurorehabilitation and Restorative Neuroscience NetworkK12HD093427 · NICHD · GEORGETOWN UNIVERSITY · PI BREGMAN, BARBARA S, DROMERICK, ALEXANDER W · 2017 to 2021
$3.9M
Stroke Central Atlantic Network for Research (SCANR)U24NS107222 · NINDS · MEDSTAR HEALTH RESEARCH INSTITUTE · PI Amie Hsia, Peter Ethan Turkeltaub · 2018 to 2026
$2.6M
Stroke National Capital Area Network for Research (SCANR)U10NS086513 · NINDS · MEDSTAR HEALTH RESEARCH INSTITUTE · PI DROMERICK, ALEXANDER W, HSIA, AMIE · 2013 to 2017
$1.8M
NCATS NIH HHS TL1 TR001431NICHD NIH HHS K12 HD093427NINDS NIH HHS U01 NS056256NINDS NIH HHS U10 NS086513NINDS NIH HHS U24 NS107222
6 · The paper itself

Abstract

objectiveTo determine the extent to which estimates of sample and effect size in stroke rehabilitation trials can be affected by simple summation of ordinal Upper Extremity Fugl-Meyer (UEFM) items compared with a Rasch-rescaled UEFM.

designRasch analysis of Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) phase III trial data, comparing 3 upper extremity (UE) motor treatments in stroke survivors enrolled 45.8±22.4 days poststroke. Participants underwent a structured UE motor training known as the Accelerated Skill Acquisition Program, usual and customary care, or dose-equivalent care. UEFM data from baseline, postintervention, and 6 and 12 months later were included for analysis.

settingOutpatient stroke rehabilitation.

participantsICARE participants (N=361).

interventionsNot applicable.

main outcome measuresItem difficulties, person abilities, and sample size.

resultsBecause of their ordinality, summed raw UEFM scores measured motor impairment inconsistently across different ranges of stroke severity relative to the rescaled UEFM. In the full ICARE sample, raw UEFM understated scores relative to the rescaled UEFM by 7.4 points for the most severely impaired, but overstated scores by up to 8.4 points toward the ceiling. As a result, 50.9% of all UEFM observations showed a residual error greater than 10% of the total UEFM score. Relative to the raw scores, the rescaled UEFM improved the effect size of change in motor impairment between baseline and 1 year (d=0.35). For a hypothetical 3-arm trial resembling ICARE, UEFM rescaling reduced the required sample size by 32% (n=108) compared with raw UEFM (n=159).

conclusionsIn UE rehabilitation trials, a rescaled UEFM potentially decreases sample size by one-third, decreasing costs, duration, and the number of subjects exposed to experimental risks. This benefit is obtained through increased measurement efficiency. Reductions in ceiling effects are also possible. These findings apply to ICARE-like trials. Confirmatory validation in another phase III trial is needed.

Indexed as

AgedAmbulatory CareDisability EvaluationFemaleHumansLongitudinal StudiesMaleMiddle AgedMulticenter Studies as TopicRandomized Controlled Trials as TopicRecovery of FunctionResearch DesignStroke RehabilitationUpper ExtremityClinical trials as topicData accuracyDisability evaluationRecovery of functionRehabilitationSample sizeStrokeStroke rehabilitationUpper extremity

Identifiers

PMID32991872
PMCPMC7854957
OpenAlexW3087963348

What OpenQuestion holds

Textmetadata
LicenceTDM
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.