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

Study acronym: PD-NMES-SPAS
StatusCompleted
PhaseNot applicable
Started

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Record History

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  1. Re-verified, no change to tracked fields
  2. Trial completed Show 5 more changesShow less
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised
    • Publications: details revised at 35 of 37 entries
    • Study description expanded, about 4 words
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Secondary endpoints: 4 to 5
    v2
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07321158
Lead Sponsor University of West Attica
Collaborators: Attikon Hospital
Conditions
(from sponsor)		 Pyramidal Tract-related Spasticity, Upper Motor Neuron Lesion
Related terms Muscle Spasticity
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov