Evidence map›Paper›PMID 32883297›Full record

Trial reportJournal of neuroengineering and rehabilitation2020

Toward a hybrid exoskeleton for crouch gait in children with cerebral palsy: neuromuscular electrical stimulation for improved knee extension.

Blynn L Shideler, Thomas C Bulea, Ji Chen, Christopher J Stanley, Andrew J Gravunder, Diane L Damiano

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in Journal of neuroengineering and rehabilitation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01961557 (Evaluating an Extension Assist Knee Ankle Foot Orthosis to Improve Gait in Children With Movement Disorders), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% 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.

NCT01961557 nacompletednot on this map

Evaluating an Extension Assist Knee Ankle Foot Orthosis to Improve Gait in Children With Movement Disorders

TypeinterventionalSponsorNational Institutes of Health Clinical Center (CC)Ran2015 to 2025Enrolled24ConditionsIncomplete Spinal Cord Injury, Muscular Dystrophy, Spina Bifida, Cerebral PalsyArmsEA-KAFO
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Effectiveness of Neuromuscular Electrical Stimulation in Preventing Venous Thromboembolism: A Meta-Analysis Based on Randomized Controlled Trials.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
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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

6 authors at 1 institution in 1 country.

Blynn L ShidelerNational Institutes of Health, Clinical Center, Rehabilitation Medicine Department, Functional & Applied Biomechanics Section, Bldg 10 CRC Rm 1-1469, 10 Center Dr. MSC 1604, Bethesda, MD, 20892-1604, USA.
Thomas C BuleaNational Institutes of Health, Clinical Center, Rehabilitation Medicine Department, Functional & Applied Biomechanics Section, Bldg 10 CRC Rm 1-1469, 10 Center Dr. MSC 1604, Bethesda, MD, 20892-1604, USA.
Ji ChenNational Institutes of Health, Clinical Center, Rehabilitation Medicine Department, Functional & Applied Biomechanics Section, Bldg 10 CRC Rm 1-1469, 10 Center Dr. MSC 1604, Bethesda, MD, 20892-1604, USA.
Christopher J StanleyNational Institutes of Health, Clinical Center, Rehabilitation Medicine Department, Functional & Applied Biomechanics Section, Bldg 10 CRC Rm 1-1469, 10 Center Dr. MSC 1604, Bethesda, MD, 20892-1604, USA.
Andrew J GravunderNational Institutes of Health, Clinical Center, Rehabilitation Medicine Department, Functional & Applied Biomechanics Section, Bldg 10 CRC Rm 1-1469, 10 Center Dr. MSC 1604, Bethesda, MD, 20892-1604, USA.
Diane L DamianoNational Institutes of Health, Clinical Center, Rehabilitation Medicine Department, Functional & Applied Biomechanics Section, Bldg 10 CRC Rm 1-1469, 10 Center Dr. MSC 1604, Bethesda, MD, 20892-1604, USA. damianod@cc.nih.gov.
National Institutes of Health Clinical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNeuromuscular Electrical Stimulation (NMES) has been utilized for many years in cerebral palsy (CP) with limited success despite its inherent potential for improving muscle size and/or strength, inhibiting or reducing spasticity, and enhancing motor performance during functional activities such as gait. While surface NMES has been shown to successfully improve foot drop in CP and stroke, correction of more complex gait abnormalities in CP such as flexed knee (crouch) gait remains challenging due to the level of stimulation needed for the quadriceps muscles that must be balanced with patient tolerability and the ability to deliver NMES assistance at precise times within a gait cycle.

methodsThis paper outlines the design and evaluation of a custom, noninvasive NMES system that can trigger and adjust electrical stimulation in real-time. Further, this study demonstrates feasibility of one possible application for this digitally-controlled NMES system as a component of a pediatric robotic exoskeleton to provide on-demand stimulation to leg muscles within specific phases of the gait cycle for those with CP and other neurological disorders who still have lower limb sensation and volitional control. A graphical user interface was developed to digitally set stimulation parameters (amplitude, pulse width, and frequency), timing, and intensity during walking. Benchtop testing characterized system delay and power output. System performance was investigated during a single session that consisted of four overground walking conditions in a 15-year-old male with bilateral spastic CP, GMFCS Level III: (1) his current Ankle-Foot Orthosis (AFO); (2) unassisted Exoskeleton; (3) NMES of the vastus lateralis; and (4) NMES of the vastus lateralis and rectus femoris. We hypothesized in this participant with crouch gait that NMES triggered with low latency to knee extensor muscles during stance would have a modest but positive effect on knee extension during stance.

resultsThe system delivers four channels of NMES with average delays of 16.5 ± 13.5 ms. Walking results show NMES to the vastus lateralis and rectus femoris during stance immediately improved mean peak knee extension during mid-stance (p = 0.003*) and total knee excursion (p = 0.009*) in the more affected leg. The electrical design, microcontroller software and graphical user interface developed here are included as open source material to facilitate additional research into digitally-controlled surface stimulation ( github.com/NIHFAB/NMES ).

conclusionsThe custom, digitally-controlled NMES system can reliably trigger electrical stimulation with low latency. Precisely timed delivery of electrical stimulation to the quadriceps is a promising treatment for crouch. Our ultimate goal is to synchronize NMES with robotic knee extension assistance to create a hybrid NMES-exoskeleton device for gait rehabilitation in children with flexed knee gait from CP as well as from other pediatric disorders.

trial registrationclinicaltrials.gov, ID: NCT01961557 . Registered 11 October 2013; Last Updated 27 January 2020.

Indexed as

Exoskeleton DeviceProsthesis DesignAdolescentCerebral PalsyElectric Stimulation TherapyGait Disorders, NeurologicHumansKnee JointMaleMuscle SpasticityCrouch gaitExoskeletonFunctional electrical stimulation (FES)Graphical user interface (GUI)

Identifiers

PMID32883297
PMCPMC7469320
OpenAlexW3082052571

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.