Evidence map›Paper›PMID 35549747›Full record

ArticleTrials2022

Efficacy of contralaterally controlled functional electrical stimulation compared to cyclic neuromuscular electrical stimulation and task-oriented training for recovery of hand function after stroke: study protocol for a multi-site randomized controlled trial.

Jayme S Knutson, Amy S Friedl, Kristine M Hansen, Mary Y Harley, A M Barrett, Preeti Raghavan, Ela B Plow, Douglas D Gunzler, John Chae

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03574623 (Contralaterally Controlled FES Versus Cyclic NMES for Hand Function After Stroke), which is not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
0.9field-weighted citation impact, top 25% 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.

NCT03574623 nacompletednot on this map

Contralaterally Controlled FES Versus Cyclic NMES for Hand Function After Stroke

TypeinterventionalSponsorMetroHealth Medical CenterRan2019 to 2024Enrolled132ConditionsStroke, Upper Extremity Paresis, HemiplegiaArmsElectrical Stimulator, Occupational Therapy
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. [Effects of Mirror Therapy Combined With Task-Oriented Training on Limb Function Recovery in Stroke Patients With Hemiplegia].Sichuan da xue xue bao. Yi xue ban = Journal of Sichuan University. Medical science edition · 2023
    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

9 authors at 4 institutions in 1 country.

Jayme S KnutsonThe MetroHealth System, Cleveland, OH, USA. jknutson@metrohealth.org.ORCID http://orcid.org/0000-0001-9893-3746
Amy S FriedlThe MetroHealth System, Cleveland, OH, USA.
Kristine M HansenThe MetroHealth System, Cleveland, OH, USA.
Mary Y HarleyThe MetroHealth System, Cleveland, OH, USA.
A M BarrettEmory University, Atlanta, GA, USA.
Preeti RaghavanJohns Hopkins University, Baltimore, MD, USA.
Ela B PlowCleveland Clinic Foundation, Cleveland, OH, USA.
Douglas D GunzlerThe MetroHealth System, Cleveland, OH, USA.
John ChaeThe MetroHealth System, Cleveland, OH, USA.
MetroHealth · USCleveland Clinic · USEmory University · USJohns Hopkins University · US

Funding

Clinical and Translational Science Collaborative of ClevelandUL1TR002548 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI MCCOMSEY, GRACE A · 2018 to 2022
$35.5M
Clinical and Translational Science Collaborative of Northern Ohio, Catalyzing Linkages to Equity in Health (CLE Health)UM1TR004528 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI GRACE A MCCOMSEY · 2023 to 2026
$32.1M
Contralaterally Controlled FES versus Cyclic NMES for Hand Function after StrokeR01HD092351 · NICHD · CASE WESTERN RESERVE UNIVERSITY · PI KNUTSON, JAYME S. · 2018 to 2022
$3.2M
Contralaterally Controlled FES Combined with Brain Stimulation for Severe Upper limb HemiplegiaR01HD098073 · NICHD · CLEVELAND CLINIC LERNER COM-CWRU · PI PLOW, ELA B · 2019 to 2024
$3.1M
NCATS NIH HHS UL1 TR002548NCATS NIH HHS UM1 TR004528NICHD NIH HHS R01 HD092351NICHD NIH HHS R01 HD098073
6 · The paper itself

Abstract

backgroundMulti-site studies in stroke rehabilitation are important for determining whether a technology and/or treatment can be successfully administered by sites other than the originating site and with similar positive outcomes. This study is the first multi-site clinical trial of a novel intervention for post-stroke upper limb rehabilitation called contralaterally controlled functional electrical stimulation (CCFES). Previous pilot and single-site studies showed positive effects of CCFES on upper limb impairment and hand dexterity in stroke survivors. The main purpose of this study is to confirm and demonstrate the efficacy of CCFES in a larger group of most likely responders across multiple clinical sites.

methodsUp to 129 stroke survivors with moderate to severe upper extremity hemiparesis at 4 clinical trial sites will be randomized to CCFES, cyclic neuromuscular electrical stimulation (cNMES), or task-oriented-training (TOT). Participants will receive 12 weeks of group-specific therapy. Blinded assessments of upper limb impairment and activity limitation, quality of life, and neurophysiology will be used to compare outcomes at baseline, after treatment, and up to 6 months post-treatment. The primary endpoint is change in dexterity from baseline to 6 months post-treatment. DISCUSSION: Loss of hand function following stroke is a major rehabilitation problem affecting millions of people per year globally. More effective rehabilitation therapies are needed to restore hand function in these individuals. This study will determine whether CCFES therapy produces greater improvements in upper extremity function than cNMES or TOT, and will begin to elucidate the different mechanisms underlying each of the three treatments. This multi-site study is a critical step in advancing a novel method of rehabilitation toward clinical translation and widespread dissemination.

trial registrationClinicalTrials.gov NCT03574623 . Registered prior to first enrollment; July 2, 2018.

Indexed as

StrokeStroke RehabilitationElectric StimulationHumansMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicRecovery of FunctionTreatment OutcomeUpper ExtremityElectrical stimulationHemiparesisStroke rehabilitationTherapyUpper extremity

Identifiers

PMID35549747
PMCPMC9097385
OpenAlexW4280555833

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.