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Die Wirksamkeit verschiedener Impulsdauern von NMES bei Patienten mit Pyramidenbahn-bedingter Spastizität gemessen mit neurophysiologischen Werkzeugen (PD-NMES-SPAS)

5. Oktober 2026 aktualisiert von: Athanasios K. Chasiotis, University of West Attica

Die Wirksamkeit von Neuromuskulärer Elektrostimulation (NMES) mit hoher versus niedriger Pulsdauer bei Patienten mit spastischen Störungen der oberen Extremität, die auf eine Pyramidenbahnschädigung zurückzuführen sind, gemessen mit neurophysiologischen Werkzeugen: Eine randomisierte kontrollierte 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

45

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Griechenland
    • Attica
      • Athens, Attica, Griechenland, 12462
        • Attikon Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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)
Gerät: 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
Sonstiges: 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:
  • Kontrollgruppe
Experimental: 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)
Sonstiges: 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:
  • Kontrollgruppe
Gerät: 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
Sonstiges: 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)
Sonstiges: 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:
  • Kontrollgruppe

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in surface electromyography (EMG) parameters
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Modified Ashworth Scale
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of West Attica

Mitarbeiter

Attikon Hospital

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

6. Januar 2026

Primärer Abschluss (Tatsächlich)

30. Juni 2026

Studienabschluss (Tatsächlich)

31. Juli 2026

Studienanmeldedaten

Zuerst eingereicht

10. Dezember 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Dezember 2025

Zuerst gepostet (Tatsächlich)

6. Januar 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Oktober 2026

Zuletzt verifiziert

1. Oktober 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 45492/16-05-2025

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NEIN

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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