The Effectiveness of Different Pulse Duration of NMES in Patients With Pyramidal Tract-related Spasticity Measured by Neurophysiological Tools
NCT ID: NCT07321158
Last Updated: 2026-01-06
Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
45 participants
INTERVENTIONAL
2026-01-06
2026-07-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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)
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.
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.
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)
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.
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.
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)
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.
Interventions
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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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* absence of cognitive dysfunction
* normal vital signs
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Attikon Hospital
OTHER
University of West Attica
OTHER
Responsible Party
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Athanasios K. Chasiotis
Physiotherapist, MSc, PHDc
Central Contacts
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Athanasios K. Chasiotis, Physiotherapist
Role: CONTACT
References
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Other Identifiers
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41389/06-05-2025
Identifier Type: -
Identifier Source: org_study_id
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