EMG-vejledt Neuro-Muskulær Koordinationsforbedring (NICE) Genoptræning Gennem Menneskemaskine-interaktion (NICE)
15. juni 2026 opdateret af: Jinsook Roh, University of Houston
Neuro-Interneuromuskulær Koordinationsforbedring (NICE) Rehabilitering
Formålet med dette studie er at udvikle Neuro-Intermuskulær Koordinationsforbedring (NICE) rehabilitering, en ny neuromuskulær kontrolsignalguidet strategi, der visuelt vejleder slagtilfaldspatienter til individuelt at aktivere grupper af synergistiske muskler gennem menneske-maskine-interaktion.
I sidste ende vil udviklingen føre til bedre klinisk motorisk restitution, bedre livskvalitet og lavere sundhedsomkostninger forbundet med funktionsnedsættelsen.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Slagtilfælde er den førende årsag til alvorlige langvarige funktionsnedsættelser og rammer 9,4 millioner amerikanere. Hvert år får omkring 800.000 mennesker et slagtilfælde, selv i USA. Kronisk motorisk nedsættelse i den øvre ekstremitet er en væsentlig bidragende faktor til funktionsnedsættelse; funktionel brug af den påvirkede øvre ekstremitet i dagligdagen er en nøglefaktor for øget selvstændighed, tilbagevenden til arbejde og samlet livskvalitet. Derfor er effektiv og innovativ behandling til adressering af langvarig funktionsnedsættelse både et stort folkesundhedsbehov og en økonomisk nødvendighed.
Studiet vil udvikle en innovativ menneske-maskine-interaktionsplatform for at målrette og forbedre inter-ledkoordination og motorisk funktion ved at forbedre muskulær koordination i den øvre ekstremitet. Dette studie vil i alt inkludere 38 kroniske slagtilfælde-overlevere, der vil blive tilfældigt tildelt enten neuromuskulær-koordinationsstyret træning (NICE; terapigruppe) eller kraftstyret træning (kontrollgruppe). Inklusionskriterierne omfatter primært: (1) at have oplevet et iskæmisk eller hæmoragisk slagtilfælde mindst 6 måneder tidligere (kronisk slagtilfælde); (2) at være mellem 21 og 80 år gammel; (3) ikke at have modtaget botulinumtoksinbehandling i den påvirkede arm inden for de seneste 3 måneder; og (4) ikke at have kognitive nedsættelser, der kan påvirke opgaveløsning eller evnen til at give informeret samtykke.
Dette studie vil evaluere effekterne af begge rehabiliteringsøvelser på muskelkoordination, standardiserede kliniske scoringssystemer, kinetik og elektroencefalogram.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
48
Fase
- Tidlig fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jinsook Roh, PhD
- Telefonnummer: 7137432578
- E-mail: jroh@Central.UH.EDU
Studiesteder
-
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Texas
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Houston, Texas, Forenede Stater, 77045
- University of Houston
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Kontakt:
- JIN-SOOK ROH, PhD
- Telefonnummer: 6173680050
- E-mail: jsroh@central.uh.edu
-
Ledende efterforsker:
- Jinsook Roh, PhD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- Iskaemisk eller hæmoragisk apopleksi
- Alder mellem 21 og 80 år
- Ikke modtager botulinumtoxin på den ramte arm inden for de seneste 3 måneder
- MAS ≤ 3 omkring albue og skulder
Eksklusionskriterier:
- har en ortopædisk lidelse i overekstremiteterne;
- kognitiv svækkelse tilstrækkelig til at forstyrre informeret samtykke eller vellykket gennemførelse af protokollen (Montreal Cognitive Assessment (MoCA) score ≤ 26);
- en tidligere neurologisk sygdom;
- anæstesi af ledpositionssansen i overekstremiteterne;
- er gravid eller har en mulighed for at være det (selvrapporteret);
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Neuromuscular coordination enhancement (NICE) intervention
Post-stroke participants will perform a center-out task by activating individual motor modules (generating coordinated isometric contractions of muscles) to move the cursor on a screen while electromyographic (EMG) signals are recorded.
Activation of each muscle (or muscle group) will be mapped to 1 of 4 directions within the multi-dimensional cursor space.
We will derive the cursor position in real time using Motor module activation magnitudes recorded from arm muscles.
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Neuro-Intermuscular Coordination Enhancement (NICE) is a motor module-guided rehabilitation intervention designed to improve upper-extremity motor recovery after stroke by retraining impaired intermuscular coordination patterns. Participants perform isometric upper-extremity force-generation tasks using a human-machine interface while receiving real-time visual feedback derived from motor module recruitment signals calculated from surface electromyography (EMG). Individualized motor module targets are derived from the participant's less-affected upper extremity and used to guide selective recruitment of impaired coordination patterns in the more-affected upper extremity. Participants will complete 18 one-hour training sessions over six weeks (3 sessions/week). During training, participants perform repetitive target-matching tasks that require preferential recruitment of specific motor modules while minimizing unintended activation of non-target modules. |
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Aktiv komparator: EMG-amplitude biofeedback exercise
Participants will perform a center-out target matching tasks where individual muscle EMGs are used to move a cursor on the visual feedback display to match one of 4 different targets presented to them.
Here, just the EMG amplitude, and not the coordination is focused on.
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EMG Amplitude Biofeedback Exercise is an active comparator rehabilitation intervention designed to improve upper-extremity motor function after stroke through targeted muscle activation training.
Participants perform isometric upper-extremity exercises using a human-machine interface with real-time EMG amplitude-based visual feedback.
Individualized muscle activation targets derived from the less-affected upper extremity guide training of the more-affected upper extremity.
Participants will complete 18 one-hour sessions over 6 weeks (3 sessions/week).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Fugl-Meyer Assessment (FMA) score
Tidsramme: Baseline, six- week, 10-week, and 18-week follow-ups.
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Motor impairment after stroke will be measured by upper extremity FMA (UE-FMA).
The maximum UE-FMA motor score is 66 (i.e., 0: complete motor impairment; 66: normal motor performance).
Each item is scored on a 3-point scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
The FMA score reflects the level of upper extremity motor impairment.
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Baseline, six- week, 10-week, and 18-week follow-ups.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Similarity Score of Intermuscular Coordination Patterns (or Motor Modules)
Tidsramme: Baseline, six- week, 10-week, and 18-week follow-ups.
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Surface EMGs will be recorded from 8 key arm muscles during a 54-target isometric force generation task.
A dimensionality reduction method (non-negative matrix factorization (NNMF)) will be applied to identify intermuscular coordination patterns - operational definition of motor modules in the field of motor neuroscience.
They are mathematically 8-dimensional unit vectors.
Similarity score is the scalar product (or dot product) between a pair of intermuscular coordination patterns in comparison (i.e., motor modules).
We compute the similarity score between the less-affected and the more-affected arms.
Also, surface EMGs will be recorded from 8 key arm muscles during 3D dynamic reaching tasks.
NNMF will be applied to EMGs to identify and compare intermuscular coordination patterns.
Similarity score is the scalar product between motor modules (i.e., intermuscular coordination patters) of the more-affected arm in stroke group and dominant arm in healthy group.
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Baseline, six- week, 10-week, and 18-week follow-ups.
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Kinematic Synergy Similarity Score
Tidsramme: Baseline, six-week, 10-week, and 18-week follow-ups.
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Kinematic synergies are a representation of multi-joint coordination.
It will be identified using NNMF algorithm applied to the joint kinematic data obtained from 3D dynamic point-to-point reaching tasks.
Kinematic synergy similarity between stroke and healthy will be calculated using their scalar product.
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Baseline, six-week, 10-week, and 18-week follow-ups.
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Pairwise joint angle-to-angle correlation value
Tidsramme: Baseline, six- week, 10-week, and 18-week follow-ups.
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Pairwise joint angle-to-angle correlation is a way to see the joint coupling using kinematic data.
It will be calculated using Pearson's correlation coefficient between joint angles during the point-to-point reaching task.
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Baseline, six- week, 10-week, and 18-week follow-ups.
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Active range of motion
Tidsramme: Baseline, six-week, 10-week, and 18-week follow-ups.
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The active range of motion will be calculated from full active range tasks for shoulder flexion/extension, internal/external rotation, abduction/adduction, elbow flexion/extension, and wrist pronation/supination. Kinematic joint positions and angles will be used to calculate the same.
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Baseline, six-week, 10-week, and 18-week follow-ups.
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EEG Spectral power ratios
Tidsramme: Baseline and six-week follow-up.
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EEG-derived spectral power ratios will be calculated, in resting and task conditions, across different frequency bands (delta, theta, alpha, beta, gamma) and different events (onset, successful match, etc.) across four different directions of target match.
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Baseline and six-week follow-up.
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EEG-derived Brain Symmetry Index
Tidsramme: Baseline and six-week follow-up.
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The revised brain symmetry index with EEG signals will be computed in the resting state during eyes open and closed conditions.
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Baseline and six-week follow-up.
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Cortico-muscular connectivity
Tidsramme: Baseline and six-week follow-up.
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Functional connectivity using a directed transfer function will be computed to identify the information flow and coherence among EEG and EMG signals in the desired brain region and muscle activation associated with directional 4-target isometric force generation.
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Baseline and six-week follow-up.
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Cortico-cortical connectivity
Tidsramme: Baseline and six-week follow-up.
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Functional connectivity using a directed transfer function will be computed to identify the information flow and coherence among EEG signals from different regions of interest (sources, e.g., ipsi and contralesional fronto-parietal regions, primary motor cortex and somatosensory cortices).
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Baseline and six-week follow-up.
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Participant recruitment rate
Tidsramme: From participant recruitment beginning to enrollment completion
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Recruitment rate will be calculated as the number of participants enrolled per month during the recruitment period.
This is a feasibility outcome.
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From participant recruitment beginning to enrollment completion
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Participant intervention adherence
Tidsramme: Throughout the 6-week intervention period.
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Intervention adherence will be calculated as the percentage of scheduled intervention sessions completed by each participant.
This is a feasibility outcome.
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Throughout the 6-week intervention period.
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Participant Tolerance of the Intervention
Tidsramme: Throughout the 6-week intervention period.
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Participant tolerance will be measured as the number and percentage of participants who complete intervention sessions without stopping due to discomfort, fatigue, pain, or other intolerance-related reasons.
This is a feasibility outcome.
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Throughout the 6-week intervention period.
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Intervention fidelity
Tidsramme: Throughout the 6-week intervention period.
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Intervention fidelity will be calculated as the percentage of intervention sessions delivered according to the study protocol.
This is a feasibility outcome.
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Throughout the 6-week intervention period.
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Dose equivalence between the intervention groups
Tidsramme: Throughout the 6-week intervention period.
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Dose equivalence will be assessed by comparing total intervention dose between groups, measured as total minutes of training and/or number of completed sessions per participant.
This is a feasibility outcome.
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Throughout the 6-week intervention period.
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NICE-specific training feasibility
Tidsramme: Throughout the 6-week intervention period.
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NICE-specific feasibility will be assessed as the percentage of NICE intervention sessions in which the NICE training system/protocol is successfully implemented as intended.
This is a feasibility outcome.
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Throughout the 6-week intervention period.
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Participant retention rate
Tidsramme: Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
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Retention rate will be calculated as the percentage of enrolled participants who complete each scheduled follow-up assessment.
This is a feasibility outcome.
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Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
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Successful acquisition of study data
Tidsramme: Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
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Successful data acquisition will be calculated as the percentage of expected EMG, EEG, kinematic, and clinical outcome datasets successfully collected and usable for analysis.
This is a feasibility outcome.
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Baseline, six-week, 10-week, and 18- week follow-ups and throughout the 6-week intervention period.
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Box and Block Test (BBT) score
Tidsramme: Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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The gross manual dexterity and upper extremity coordination will be assessed through BBT, which involves transfer of blocks from one compartment of a box to the other within 60 seconds.
The score is the number of blocks successfully transferred to the other side within 60 seconds.
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Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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Modified Ashworth Scale (MAS) score
Tidsramme: Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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The increase in muscle tone will be assessed through MAS around the elbow and shoulder.
MAS score ranges from 0 to 5. The MAS score reflects the severity of muscle spasticity.
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Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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Wolf Motor Function Test (WMFT) score
Tidsramme: Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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Motor function will be assessed through WMFT, which evaluates both the time and quality of performance across 17 tasks that range from simple joint movements to complex functional activities (like lifting a can or folding a towel).
Performance Time (sec) is measured, with a maximum time limit (usually 120 seconds).
Functional Ability Scale rates the quality of movement, using a 6-point ordinal scale (0 = Does not attempt with the involved arm, 1 = Attempted but cannot complete task, 2 = Completes task with great difficulty or poor movement quality, 3 = Completes task with moderate difficulty or noticeable impairment, 4 = Completes task with minor difficulty or near-normal movement, 5 = Normal movement quality and speed).
The WMFT score assesses upper extremity motor function.
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Baseline, six-week follow-up, and 10-week follow-up. Keeping a 18-week follow-up as an exploratory time point.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jinsook Roh, PhD, University of Houston
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Roh J, Cheung VC, Bizzi E. Modules in the brain stem and spinal cord underlying motor behaviors. J Neurophysiol. 2011 Sep;106(3):1363-78. doi: 10.1152/jn.00842.2010. Epub 2011 Jun 8.
- Dewald JP, Sheshadri V, Dawson ML, Beer RF. Upper-limb discoordination in hemiparetic stroke: implications for neurorehabilitation. Top Stroke Rehabil. 2001 Spring;8(1):1-12. doi: 10.1310/WA7K-NGDF-NHKK-JAGD.
- Nordin AD, Hairston WD, Ferris DP. Faster Gait Speeds Reduce Alpha and Beta EEG Spectral Power From Human Sensorimotor Cortex. IEEE Trans Biomed Eng. 2020 Mar;67(3):842-853. doi: 10.1109/TBME.2019.2921766. Epub 2019 Jun 13.
- Roh J, Beer RF, Lai A, Rho M, Karvelas KR, Nader AM, Kendall MC, Rymer WZ. The Effects of Selective Muscle Weakness on Muscle Coordination in the Human Arm. Appl Bionics Biomech. 2018 Sep 19;2018:5637568. doi: 10.1155/2018/5637568. eCollection 2018.
- Park JH, Lee H, Kwon HJ, Shin JH, Roh J, Park HS. Feasibility of Isokinetic Training to Modify Coupling of Upper Limb Muscle Synergy Activation in Stroke-affected Upper Limb. Annu Int Conf IEEE Eng Med Biol Soc. 2023 Jul;2023:1-4. doi: 10.1109/EMBC40787.2023.10339985.
- Portilla-Jimenez M, Seo G, Houston M, Hong YNG, Li S, Park HS, Zhang Y, Roh J. Improving impaired intermuscular coordination after stroke through synergy-guided human-machine interaction: a pilot study. Annu Int Conf IEEE Eng Med Biol Soc. 2024 Jul;2024:1-4. doi: 10.1109/EMBC53108.2024.10782001.
- Seo G, Park JH, Park HS, Roh J. Developing new intermuscular coordination patterns through an electromyographic signal-guided training in the upper extremity. J Neuroeng Rehabil. 2023 Sep 1;20(1):112. doi: 10.1186/s12984-023-01236-2.
- Seo G, Kishta A, Mugler E, Slutzky MW, Roh J. Myoelectric interface training enables targeted reduction in abnormal muscle co-activation. J Neuroeng Rehabil. 2022 Jul 1;19(1):67. doi: 10.1186/s12984-022-01045-z.
- Li S. Stroke Recovery Is a Journey: Prediction and Potentials of Motor Recovery after a Stroke from a Practical Perspective. Life (Basel). 2023 Oct 15;13(10):2061. doi: 10.3390/life13102061.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2027
Primær færdiggørelse (Anslået)
1. august 2032
Studieafslutning (Anslået)
1. august 2032
Datoer for studieregistrering
Først indsendt
22. oktober 2025
Først indsendt, der opfyldte QC-kriterier
8. april 2026
Først opslået (Faktiske)
15. april 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY00001333-NICE
Plan for individuelle deltagerdata (IPD)
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