Actively Recruiting
The Effectiveness of Different Pulse Duration of NMES in Patients With Pyramidal Tract-related Spasticity Measured by Neurophysiological Tools
Led by University of West Attica · Updated on 2026-03-24
45
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
Sponsors
U
University of West Attica
Lead Sponsor
A
Attikon Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effectiveness of Different Pulse Duration of NMES in Patients With Pyramidal Tract-related Spasticity Measured by Neurophysiological Tools
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed by a neurologist with first pyramidal tract damage and upper limb spasticity
- No cognitive dysfunction
- Normal vital signs
- No pharmacological treatment for spasticity affecting results
You will not qualify if you...
- Prior neurological damage to pyramidal tract
- Cognitive decline
- Skin damage on the affected limb
- Previous musculoskeletal problems on the spastic upper limb
- Presence of metallic residues on the spastic upper limb
- Seizures or psychiatric disorders
- Severe malformation or obesity (BMI >30 kg/m2)
- History of coronary or cardiovascular diseases (including deep vein thrombosis, pulmonary embolism)
- Systematic inflammatory disease
- Terminal stage cancer
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Attikon Hospital
Athens, Attica, Greece, 12462
Actively Recruiting
Research Team
A
Athanasios K. Chasiotis, Physiotherapist
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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