High Tone Power Therapy Versus Transcutaneous Electrical Nerve Stimulation on Spasticity and Selected Kinematic Gait Parameters in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Computerized electromyography (EMG) using H/M ratio
研究概览
简要总结
This study aims to compare between High tone power therapy (modulated frequency current) and Transcutaneous electrical nerve stimulation (fixed frequency current) on spasticity and selected kinematic gait parameters in stroke patients.
详细描述
Stroke is a neurological deficit attributed to an acute focal injury of the central nervous system (CNS) by a vascular cause . Stroke is one of the leading causes of disability and mortality in the globe, stroke occurs when blood flow to the brain is restricted due to a blocked or ruptured artery; the cerebral energy supply is interrupted, resulting in tissue destruction and widespread neuronal, cognitive impairments, and psychological morbidity .
Stroke is the second major cause of death and disability worldwide with over 13 million new cases annually . Stroke has been described as a major source of both mortality and global disability . Approximately 795,000 people experience stroke annually, and 60% (or 465,000) of them need rehabilitation .
Spasticity is a symptom of stroke, brain and spinal cord damage, multiple sclerosis, cerebral palsy, and other neurological illnesses that cause paralysis . The most common spastic pattern in the lower limbs is adduction and extension of the knee with an Equinovarus foot . This impacts gait patterns and daily functioning activities .
Treatment modalities for the management of spasticity include Stretching, splinting, Neuromuscular electrical stimulation (NMES), extracorporeal shock wave therapy, transcranial and spinal cord magnetic stimulation, Surgical treatment, neurectomy, rhizotomy, and myelotomy; also, many drugs used for treating spasticity oral drugs like Baclofen, Tizanidine, and injectable medications like Phenol/alcohol and Botulinum 2 toxin .
Transcutaneous electrical nerve stimulation (TENS) stimulates large diameter mechano-sensitive nerve fibers in the skin it's a non-invasive treatment that has been reported to affect pain control and sensory stimulation which is commonly used in the treatment of chronic and acute pain with possible mechanisms of action including segmental inhibition, the release of endogenous opioids, counter-irritation, nerve conduction block, increase muscle power and movement function .
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
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Duration of illness not less than six months post-stroke (Hillis A. et al., 2006).
- •Patients' age ranges from forty-five to sixty-five years (Feigin et al., 2022).
- •Body mass index from (18.5 to 24.9).
- •Patients can respond to verbal instructions (Consciousness and orientation to time, place, and person) more than 13 degrees on the Glasco coma scale (Hegazy et al., 2020).
- •Able to walk independently on an even surface without any assistive device (Fan and Yin, 2013).
- •Patients with moderate Spasticity of the ankle joint (grade 2 and 3 According to Modified Ashworth Scale) (Hegazy et al., 2020).
排除标准
- •Subjects with any other Co-existing Progressive neurological disorder (Hegazy et al., 2020).
- •Unstable Cardiac condition (E.g., Acute Myocardial infarction, severe Cardiac Failure) (Teslim et al., 2013).
- •Subjects with any anti-spastic Drugs (Chang et al., 2013).
- •Musculoskeletal disorders affecting gait kinematics such as severe arthritis, knee surgery, and total hip joint replacement, lower limb fractures less than 6 months or contractures of fixed deformity, leg length discrepancy.
- •Any previous Contracture or deformities (Hegazy et al., 2020).
- •Un co-operative patients (Gupta and Chatterjee, 2019).
- •Open wounds, burns, or Loss of sensation (Grevstad et al., 2016).
- •Patients with metal implants (von Lewinski et al., 2009).
- •Visual, auditory problems.
结局指标
主要结局
Computerized electromyography (EMG) using H/M ratio
时间窗: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
EMG is an objective device used to measure spasticity of the Soleus muscle in percentage (%)
step length symmetry
时间窗: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Gait Analyzer Smart Phone Application is an objective tool that assesses step length symmetry: the symmetry in step length between affected and unaffected lower limbs in percentage (%)
Time up and go test (TUG)
时间窗: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
This test is used to measure time taken by patient to apply sit to stand, walk a distance of 3 meters, turn and walk back to the chair in (sec.)
step time
时间窗: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Gait Analyzer Smart Phone Application is an objective tool that assesses step time in ( msec.)
step time symmetry
时间窗: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Gait Analyzer Smart Phone Application is an objective tool that assesses step time symmetry: the symmetry in time between affected and unaffected lower limbs in percentage (%)
Modified Ashworth Scale (MAS)
时间窗: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
This scale is used to measure spasticity of Calf muscle in grades from 0 to 5.
Ten-meter Walk test(10-MWT)
时间窗: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
This scale is used to measure walking speed in m/s * self-selected walking speed (SSWS) in (m/s). * fastest walking speed (FWS) in (m/s).
step length
时间窗: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Gait Analyzer Smart Phone Application is an objective tool that assesses step length by the inertial sensor system symmetry in meters (m).
Gait velocity
时间窗: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Gait Analyzer Smart Phone Application is an objective tool that assesses gait velocity (m/s).
cadence
时间窗: measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention
Gait Analyzer Smart Phone Application is an objective tool that assesses cadence: the number of steps per second in (steps/ s).
次要结局
- Lafayette Hand-held Dynamometer(measurements will be done 3 days before the start of the treatment program and will be done after 3 days post intervention)
研究者
Jasmine Magdy Mahmoud Abd-elkhalik
lecturer assistant of physical therapy for neurology and neurosurgery
Cairo University