Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

De effectiviteit van verschillende pulsduur van NMES bij patiënten met piramidebaan-gerelateerde spasticiteit gemeten met neurofysiologische hulpmiddelen (PD-NMES-SPAS)

5 oktober 2026 bijgewerkt door: Athanasios K. Chasiotis, University of West Attica

De effectiviteit van hoge versus lage pulsduur neuromusculaire elektrische stimulatie (NMES) bij patiënten met spasticiteit gerelateerd aan het piramidale kanaal van de bovenste ledematen gemeten met neurofysiologische instrumenten: een gerandomiseerde gecontroleerde studie

Spasticity is a common symptom that affects more than 50% of patients with upper motor neuron lesions due to damage on pyramidal tract. Despite the current pharmacological and physical therapy rehabilitation methods, previous studies have highlighted the beneficial role of Neuromuscular Electrical Stimulation (NMES) on managing upper limb spasticity. However, due to heterogeneity of application parameters there is a lack of a standardized protocol for spasticity management. The aim of the study will be to examine the effects of high versus low pulse duration neuromuscular electrical stimulation on upper limb spasticity on patients with pyramidal tract-related spasticity.

A total of 45 patients will be randomized (1:1:1 ratio) to either high pulse duration NMES (HPD-NMES) or low pulse duration NMES (LPD-NMES) or Control group, receiving the standard of care. Randomization will be performed by an independent investigator, who will allocate participants to one of three groups, using a random number generator, prior to baseline assessment. Each group will receive a 15min-conventional-physiotherapeutic protocol. HPD-NMES and LPD-NMES will receive an additional 30min-NMES protocol of high and low pulse duration, respectively. Pre and post intervention spasticity will be evaluated using Range of Motion (ROM) of the elbow joint through electronic goniometer, Modified Ashworth Scale (MAS) and surface electromyography (EMG). Furthermore, Modified Barthel Index (MBI) and 12-version of World Health Organization Disability Assessment Schedule (WHODAs) will be used for evaluating participants' quality of life. Statistical analysis will aim to highlight the effects of NMES both on the EMG-electrophysiological parameters and on clinical evaluation scales. Additionally, it will seek to determine which of the two NMES pulse durations produced more beneficial results in reducing spasticity levels.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Spasticity can be characterized as a clinical phenotype related to upper motor neuron syndrome and is highly correlated with pyramidal tract lesions, leading to patients' quality of life degradation. The assessment of spasticity encompasses both clinical rating scales (such as Modified Ashworh Scale, Modified Tardieu Scale and Composite Spasticity Scale) and neurophysiological approaches through surface electromyography (such as Hoffmann reflex (H-reflex) , Mwave, and Hmax/Mmax ratio (or M/H amplitude ratio), which seem to be elevated in spasticity. A wide spectrum of therapeutic modalities, including pharmacological and non-pharmacological interventions, have been developed for the management of spasticity. Among non-pharmacological interventions, physical therapy through Neuromuscular Electrical Stimulation can be used to manage upper and lower limb spasticity through the reduction of stretch reflex excitability, facilitation reciprocal inhibition and spinal excitability modulation.

This randomized controlled trial consists of:

  • Participants randomization into one control group (group A, n=15) and two intervention groups: group B (High Pulse Duration Neuromuscular Electrical Stimulation/HPD-NMES, n=15), group C (Low Pulse Duration Neuromuscular Electrical Stimulation/LPD-NMES, n=15).
  • Conventional Physiotherapy training program for 15 minutes per session, 3 times per week for 6 weeks total (groups A, B,C) and Neuromuscular Electrical Stimulation protocol for 30 minutes per session, 3 times per week for 6 weeks total (Group B=HPD-NMES and Group C=LPD-NMES)
  • Primary spasticity evaluation tool at baseline and post intervention (6weeks) through surface electromyography.
  • Secondary spasticity evaluation tools (Modified Ashworth Scale/MAS, Range of Motion/ROM, Modified Barthel Index/MBI and 12 version World Health Organization Disability Assessment Schedule 2.0/ WHODAS 2.0) at baseline and post-intervention (6 weeks).

Statistical analysis will aim to highlight the effects of NMES both on the EMG-electrophysiological parameters and on clinical evaluation scales. Additionally, it will seek to determine which of the two NMES pulse durations produced more beneficial results in reducing spasticity levels.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

45

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Griekenland
    • Attica
      • Athens, Attica, Griekenland, 12462
        • Attikon Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • diagnosis by neurologist with first damage of pyramidal tract with upper limb spasticity
  • absence of cognitive dysfunction
  • normal vital signs
  • absence of pharmacological treatment of spasticity (per os pharmacological treatment does not affect spasticity results and was not an exclusion criteria on patients' recruitment).

Exclusion Criteria:

  • prior neurological damage to pyramidal tract
  • cognitive decline
  • dermatological damages
  • prior musculoskeletal dysfunction on the upper limb with spasticity
  • presence of metallic residues on the spastic upper limb
  • presence of seizures or psychiatric disorders
  • severe malformation or obesity (BMI >30kg/m2)
  • history of coronary or other cardiovascular diseases (deep vein thrombosis, pulmonary embolism)
  • presence of systematic inflammatory disease
  • cancer on terminal stages
  • pregnancy.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: High Pulse Duration Neuromuscular Electrical Stimulation (HPD-NMES)

Participants will receive 15 minutes Conventional physiotherapy training program (same as control group) and 30 minutes High Pulse Duration Neuromuscular Electrical Stimulation (HPD-NMES)
Apparaat: High Pulse Duration Neuromuscular Electrical Stimulation Group

30 minutes High Pulse Duration Neuromuscular Electrical Stimulation (HPD-NMES)

  • NMES Application Parameters:

    • Waveform: rectangular, biphasic. Symmetrical
    • Pulse Duration:450μsec
    • Frequency: 100Hz
    • Intensity: Optical muscle contraction and patients' tolerability
    • Ramp up: 2sec
    • Ramp down:2sec
    • ON/OFFtime: 10sec/30sec (1:3)

  • Treatment Duration: 30 minutes per session, 3 times per week for 6 weeks total.

Andere namen:
  • HPD-NMES
Ander: Usual Care Group

Conventional physiotherapy training program

  • Seated upper extremity program, single limb exercises, strength training, stretching training (with or without) external resistance, Neurofacilitatory techniques (ie. Propriocetive Neuromuscular Facilitation (PNF), NeuroDevelopmental Treatment- Bobath (NDT-Bobath) etc)
  • Treatment Duration: 15minutes per session, 3 times per week for 6 weeks total.
Andere namen:
  • Controlegroep
Experimenteel: Low Pulse Duration Neuromuscular Electrical Stimulation (LPD-NMES)

Participants will receive 15 minutes Conventional physiotherapy training program (same as control group) and 30 minutes Low Pulse Duration Neuromuscular Electrical Stimulation (LPD-NMES)
Ander: Usual Care Group

Conventional physiotherapy training program

  • Seated upper extremity program, single limb exercises, strength training, stretching training (with or without) external resistance, Neurofacilitatory techniques (ie. Propriocetive Neuromuscular Facilitation (PNF), NeuroDevelopmental Treatment- Bobath (NDT-Bobath) etc)
  • Treatment Duration: 15minutes per session, 3 times per week for 6 weeks total.
Andere namen:
  • Controlegroep
Apparaat: Low Pulse Duration Neuromuscular Electrical Stimulation Group

30 minutes Low Pulse Duration Neuromuscular Electrical Stimulation (LPD-NMES)

  • NMES Application Parameters:

    • Waveform: rectangular, biphasic. Symmetrical
    • Pulse Duration:100μsec
    • Frequency: 100Hz
    • Intensity: Optical muscle contraction and patients' tolerability
    • Ramp up: 2sec
    • Ramp down:2sec
    • ON/OFFtime: 10sec/30sec (1:3)

  • Treatment Duration: 30 minutes per session, 3 times per week for 6 weeks total.

Andere namen:
  • LPD-NMES
Ander: Control

Patients will receive 15 minute conventional physiotherapy training program that includes seated upper extremity program, single limb exercises, strength training, stretching training (with or without) external resistance, Neurofacilitatory techniques (ie. Propriocepive Neuromuscular Facilitation (PNF), NeuroDevelopmental Treatment -Bobath (NDT-Bobath) etc)
Ander: Usual Care Group

Conventional physiotherapy training program

  • Seated upper extremity program, single limb exercises, strength training, stretching training (with or without) external resistance, Neurofacilitatory techniques (ie. Propriocetive Neuromuscular Facilitation (PNF), NeuroDevelopmental Treatment- Bobath (NDT-Bobath) etc)
  • Treatment Duration: 15minutes per session, 3 times per week for 6 weeks total.
Andere namen:
  • Controlegroep

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in surface electromyography (EMG) parameters
Tijdsspanne: Baseline and 6 weeks

1. Changes in surface electromyography (EMG) parameters (Hoffmann reflex(H-reflex) of the flexor carpi radialis, M wave, F response of the median nerve, Hmax/Mmax ratio (or M/H amplitude ratio), motor unit number estimation (MUNE) and F response of the spastic upper limb).
Baseline and 6 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Modified Ashworth Scale
Tijdsspanne: Baseline and 6 weeks

1. Changes in Modified Ashworth Scale (MAS) scores. A 5-item evaluation scale that assessed muscle hypertonia. The minimum score is 0 (normal muscle tone) and the maximum is 4 (limb rigid). Higher scores indicate increase in spasticity.
Baseline and 6 weeks
Range Of Motion
Tijdsspanne: Baseline and 6 weeks

Changes in Range of Motion (ROM) scores: The assessment will be conducted using an electronic goniometer to precisely determine the range of motion of the elbow joint affected by spasticity. Patients will be positioned in the supine position on the examination table with the affected side oriented toward the examiner. Then, the examiner will align the goniometer with anatomical landmarks the base of the goniometer over the lateral epicondyle of the humerus, the stable axis along the humerus and the movable axis along the radius. The angle of the elbow-flexion will be recorded, and the measured value will be substracted from 145o (the range of motion of a full elbow flexion) in order to calculate elbow extension. Decreases in elbow extension scores indicate reduction in spasticity levels.
Baseline and 6 weeks
Modified Barthel Index
Tijdsspanne: Baseline and 6 weeks

Changes in Modified Barthel Index (MBI) scores. Modified Barthel Index is an evaluation scale that assesses patient's performance in activities of daily living. It consists of 10 domains with activities of daily living and mobility. Greater scores are correlated with decreased level of dependence
Baseline and 6 weeks
World Health Organization Disability Assessment Schedule 2.0
Tijdsspanne: Baseline and 6 weeks

Changes in 12 version World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) scores: WHODAS 2.0 is an evaluation scale that assesses perceived disability associated with the health condition in the 30 days preceding its application. Is divided into six domains: i) cognition, ii) mobility, iii) self-care, iv) interpersonal relationships, v) activities of daily living and vi) participation. Each item is rated from 1 (no difficulty) to 5 (extreme difficulty or unable to do). Larger scores refer to larger disability.
Baseline and 6 weeks
Changes in biceps brachii diameter (Ultrasound, objective measure)
Tijdsspanne: Baseline and 6 weeks

Biceps brachii diameter will be objectively assessed by standardized multi-mode ultrasound at baseline and in 6 weeks in all three study groups (HPD-NMES, LPD-NMES, and Control). The diameter's assessment will be measured on 90o elbow flexion and on 0ο extension.This non-invasive, safe and reproduciple measure requires minimal time and is conducted within scheduled study visits, without altering trial design, primary outcomes, or participant burden.
Baseline and 6 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of West Attica

Medewerkers

Attikon Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 januari 2026

Primaire voltooiing (Werkelijk)

30 juni 2026

Studie voltooiing (Werkelijk)

31 juli 2026

Studieregistratiedata

Eerst ingediend

10 december 2025

Eerst ingediend dat voldeed aan de QC-criteria

26 december 2025

Eerst geplaatst (Werkelijk)

6 januari 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

5 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 45492/16-05-2025

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren