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NCT Number: NCT07321158

The Effectiveness of Different Pulse Duration of NMES in Patients With Pyramidal Tract-related Spasticity Measured by Neurophysiological Tools

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.

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Key information

Conditions

Pyramidal Tract-related Spasticity Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Upper Motor Neuron Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Attikon Hospital

Athens, Attica, 12462, Greece

Location status: Recruiting

Location contact

Athanasios K. Chasiotis Mr. Athanasios K. Chasiotis, Physiotherapist, MSc, PhDc

CONTACT

[email protected]

+306973257982

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Pulse Duration Neuromuscular Electrical Stimulation Group

Device

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.

Other names: HPD-NMES

Low Pulse Duration Neuromuscular Electrical Stimulation Group

Device

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.

Other names: LPD-NMES

Usual Care Group

Other

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.

Other names: Control Group

Primary outcomes

  1. Changes in surface electromyography (EMG) parameters

    Time frame: Baseline and 6 weeks

    • 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).

Secondary outcomes

  1. Modified Ashworth Scale

    Time frame: Baseline and 6 weeks

    • 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.

  2. Range Of Motion

    Time frame: 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.

  3. Modified Barthel Index

    Time frame: 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

  4. World Health Organization Disability Assessment Schedule 2.0

    Time frame: 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.

  5. Changes in biceps brachii diameter (Ultrasound, objective measure)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Athanasios K. Chasiotis, Physiotherapist

CONTACT

[email protected] , [email protected]

+306973257982

Sponsors and collaborators

Lead sponsor

University of West Attica

Other

Collaborators

  • Attikon Hospital

Registry information

Official study title

The Effectiveness of High Versus Low Pulse Duration Neuromuscular Electrical Stimulation (NMES) in Patients With Upper Limb Pyramidal Tract-related Spasticity Measured by Neurophysiological Tools: A Randomized Controlled Trial

Acronym: PD-NMES-SPAS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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