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.
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
prior neurological damage to pyramidal tract
cognitive decline
dermatological damages
prior musculoskeletal dysfunction on the upper limb with spasticity
Parallel
High Pulse Duration Neuromuscular Electrical Stimulation Group
Device30 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
Device30 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.
Usual Care Group
Other interventionConventional 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.
Changes in surface electromyography (EMG) parameters
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).
Modified Ashworth Scale
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.
Range Of Motion
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.
Modified Barthel Index
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
World Health Organization Disability Assessment Schedule 2.0
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.
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University of West Attica
Lead sponsor
Attikon Hospital
Collaborator
