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

March 19, 2026 updated by: Athanasios K. Chasiotis, University of West Attica

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
    • Attica
      • Athens, Attica, Greece, 12462
        • Recruiting
        • Attikon Hospital
        • Contact:
          • Athanasios K. Chasiotis Mr. Athanasios K. Chasiotis, Physiotherapist, MSc, PhDc
          • Phone Number: +306973257982
          • Email: achasiotis@uniwa.gr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Device: 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.
Other Names:
  • HPD-NMES
Other: 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.
Other Names:
  • Control Group
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)
Other: 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.
Other Names:
  • Control Group
Device: 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.
Other Names:
  • LPD-NMES
Other: 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)
Other: 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.
Other Names:
  • Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in surface electromyography (EMG) parameters
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Ashworth Scale
Time Frame: 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
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.
Baseline and 6 weeks
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
Baseline and 6 weeks
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.
Baseline and 6 weeks
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.
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of West Attica

Collaborators

Attikon Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 26, 2025

First Posted (Actual)

January 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 41389/06-05-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Upper Motor Neuron Lesion

Clinical Trials on High Pulse Duration Neuromuscular Electrical Stimulation Group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe