Evidence map›Paper›PMID 25070961›Full record

Trial reportStroke2014

Predictors and biomarkers of treatment gains in a clinical stroke trial targeting the lower extremity.

Erin Burke, Bruce H Dobkin, Elizabeth A Noser, Lori A Enney, Steven C Cramer

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

Trial report in Stroke, 2014. 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 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
4.1field-weighted citation impact, top 7% 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.

NCT00221390 phase2completednot on this map

Randomized, Placebo-controlled, Double-blind Pilot Trial to Evaluate the Safety and Efficacy of Ropinirole in Motor Recovery After Stroke

TypeinterventionalSponsorUniversity of California, IrvineRan2003 to 2007Enrolled52ConditionsCerebrovascular Accident, HemiparesisArmsRopinirole (+ physical therapy), (vs.) Placebo + physical therapy
NCT04824482 narecruitingnot on this mapstarted 2020, after this paper: background citation

GAIT Recovery in Patients aFter Acute Ischemic STroke: A Randomized Comparison of Robot-assisted and Therapist-assisted Gait Training on a Treadmill.

TypeinterventionalSponsorUniversity Hospital OlomoucRan2020 to 2026Enrolled120ConditionsIschemic StrokeArmsRobot-assisted treadmill gait training (RTGT), Therapist-assisted treadmill gait training (TTGT)
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.

  1. Pooled it
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  13. Functional magnetic resonance brain imaging of imagined walking to study locomotor function after stroke.Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology · 2021
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  15. Biomarkers of stroke recovery: Consensus-based core recommendations from the Stroke Recovery and Rehabilitation Roundtable.International journal of stroke : official journal of the International Stroke Society · 2017
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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

5 authors at 2 institutions in 1 country.

Erin BurkeDepartments of Anatomy and Neurobiology (E.B., S.C.C.) and Neurology (S.C.C.), University of California, Irvine; Department of Neurology, University of California, Los Angeles (B.H.D.); Department of Neurology, University of Texas, Houston (E.A.N.); and Neurosciences Therapy Area Unit, GlaxoSmithKline, Research Triangle Park, NC (L.A.E.).
Bruce H DobkinDepartments of Anatomy and Neurobiology (E.B., S.C.C.) and Neurology (S.C.C.), University of California, Irvine; Department of Neurology, University of California, Los Angeles (B.H.D.); Department of Neurology, University of Texas, Houston (E.A.N.); and Neurosciences Therapy Area Unit, GlaxoSmithKline, Research Triangle Park, NC (L.A.E.).
Elizabeth A NoserDepartments of Anatomy and Neurobiology (E.B., S.C.C.) and Neurology (S.C.C.), University of California, Irvine; Department of Neurology, University of California, Los Angeles (B.H.D.); Department of Neurology, University of Texas, Houston (E.A.N.); and Neurosciences Therapy Area Unit, GlaxoSmithKline, Research Triangle Park, NC (L.A.E.).
Lori A EnneyDepartments of Anatomy and Neurobiology (E.B., S.C.C.) and Neurology (S.C.C.), University of California, Irvine; Department of Neurology, University of California, Los Angeles (B.H.D.); Department of Neurology, University of Texas, Houston (E.A.N.); and Neurosciences Therapy Area Unit, GlaxoSmithKline, Research Triangle Park, NC (L.A.E.).
Steven C CramerDepartments of Anatomy and Neurobiology (E.B., S.C.C.) and Neurology (S.C.C.), University of California, Irvine; Department of Neurology, University of California, Los Angeles (B.H.D.); Department of Neurology, University of Texas, Houston (E.A.N.); and Neurosciences Therapy Area Unit, GlaxoSmithKline, Research Triangle Park, NC (L.A.E.). scramer@uci.edu.
University of California, Los Angeles · USUniversity of Houston · US

Funding

ZOVIRAX CREAM TO TREAT HERPES LABIALIS IN ADOLESCENTSM01RR000827 · NCRR · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI ZELL, JASON · 1985 to 2010
$74.3M
Institute for Clinical and Translational ScienceUL1TR000153 · NCATS · UNIVERSITY OF CALIFORNIA-IRVINE · PI COOPER, DAN M · 2012 to 2015
$12.1M
Motor Function after StrokeR01NS059909 · NINDS · UNIVERSITY OF CALIFORNIA-IRVINE · PI CRAMER, STEVEN C. · 2009 to 2013
$2.0M
fMRI Predictor Model for Stroke Locomotor RehabilitationR01HD046740 · NICHD · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DOBKIN, BRUCE H · 2005 to 2008
$1.6M
Brain plasticity and rehabilitation after strokeK24HD074722 · NICHD · UNIVERSITY OF CALIFORNIA-IRVINE · PI CRAMER, STEVEN C. · 2013 to 2017
$588k
NCATS NIH HHS UL1 TR000153NCRR NIH HHS 5M011 RR-00827NCRR NIH HHS M01 RR000827NICHD NIH HHS K24 HD074722NICHD NIH HHS R01 HD046740NICHD NIH HHS R01 HD46740NINDS NIH HHS R01 NS059909
6 · The paper itself

Abstract

background and purposeBehavioral measures are often used to distinguish subgroups of patients with stroke (eg, to predict treatment gains, stratify clinical trial enrollees, or select rehabilitation therapy). In studies of the upper extremity, measures of brain function using functional magnetic resonance imaging (fMRI) have also been found useful, but this approach has not been examined for the lower extremity. The current study hypothesized that an fMRI-based measure of cortical function would significantly improve prediction of treatment-induced lower extremity behavioral gains. Biomarkers of treatment gains were also explored.

methodsPatients with hemiparesis 1 to 12 months after stroke were enrolled in a double-blind, placebo-controlled, randomized clinical trial of ropinirole+physical therapy versus placebo+physical therapy, results of which have previously been reported (NCT00221390).(15) Primary end point was change in gait velocity. Enrollees underwent baseline multimodal assessment that included 19 measures spanning 5 assessment categories (medical history, impairment, disability, brain injury, and brain function), and also underwent reassessment 3 weeks after end of therapy.

resultsIn bivariate analysis, 8 baseline measures belonging to 4 categories (medical history, impairment, disability, and brain function) significantly predicted change in gait velocity. Prediction was strongest, however, using a multivariate model containing 2 measures (leg Fugl-Meyer score and fMRI activation volume within ipsilesional foot sensorimotor cortex). Increased activation volume within bilateral foot primary sensorimotor cortex correlated positively with treatment-induced leg motor gains.

conclusionsA multimodal model incorporating behavioral and fMRI measures best predicted treatment-induced changes in gait velocity in a clinical trial setting. Results also suggest potential use of fMRI measures as biomarkers of treatment gains.

Indexed as

Stroke RehabilitationAdultAgedCerebral CortexCombined Modality TherapyDouble-Blind MethodFemaleGaitHumansIndolesLower ExtremityMagnetic Resonance ImagingMaleMiddle AgedParesisStrokeIndolesropinirolebiomarkersneuroimagingneuroplasticitystroke

Identifiers

PMID25070961
PMCPMC4129459
OpenAlexW1982789449

What OpenQuestion holds

Textmetadata
LicenceTDM
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.