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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Changes in surface electromyography (EMG) parameters
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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)
干预措施: High Pulse Duration Neuromuscular Electrical Stimulation Group (Device)
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)
干预措施: Usual Care Group (Other)
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)
干预措施: Low Pulse Duration Neuromuscular Electrical Stimulation Group (Device)
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)
干预措施: Usual Care Group (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)
干预措施: Usual Care Group (Other)
结局指标
主要结局
Changes in surface electromyography (EMG) parameters
时间窗: 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).
次要结局
- Modified Ashworth Scale(Baseline and 6 weeks)
- Range Of Motion(Baseline and 6 weeks)
- Modified Barthel Index(Baseline and 6 weeks)
- World Health Organization Disability Assessment Schedule 2.0(Baseline and 6 weeks)
- Changes in biceps brachii diameter (Ultrasound, objective measure)(Baseline and 6 weeks)
研究者
Athanasios K. Chasiotis
Physiotherapist, MSc, PHDc
University of West Attica