Effects of Extracorporeal Shock Wave for Upper Limb Flexor Spasticity in Stroke Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale (VAS)
研究概览
简要总结
Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity.
详细描述
This study aimed to evaluate the effects of focused Extracorporeal Shock Wave Therapy (ESWT) on upper limb flexor spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific forearm flexor muscles, and a control group receiving placebo treatments mimicking the shockwave therapy, with treatments administered twice weekly over two weeks for a total of four sessions.
The efficacy of the treatment was measured using a comprehensive set of assessment tools, including range of motion, hand grip strength, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, ultrasound strain elastography, and electromyography. The outcomes were evaluated at multiple points in time: before treatment, and 1, 4, 12, and 24 weeks after the therapy concluded, to assess both immediate and sustained effects of the treatment on upper limb function and spasticity in stroke survivors.
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, Outcomes Assessor)
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
- •Individuals aged 18 years or older with unilateral cerebral stroke.
- •Wrist and finger flexor muscle tone with a score greater than 1 on the Modified Ashworth Scale.
- •Stable medical condition and vital signs.
- •Conscious and able to comply with instructions.
排除标准
- •History of more than one stroke, traumatic brain injury, or cerebral neoplasm.
- •Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson's disease) or other musculoskeletal diseases affecting muscle tone assessment.
- •Contraindications for shockwave intervention, such as malignancies, coagulopathies, local infections, or use of cardiac pacemakers.
- •Undergone shockwave therapy or botulinum toxin injections for post-stroke spasticity in the past three months.
- •Cognitive, consciousness, or language impairments preventing participation in the intervention or functional assessments.
研究组 & 干预措施
Focused Extracorporeal Shock Wave Therapy
Participants in this arm will receive focused Extracorporeal Shock Wave Therapy (ESWT) targeting three specific muscles: the flexor carpi ulnaris, flexor carpi radialis, and flexor digitorum superficialis. Each muscle will receive 1,500 shockwave shots per session, accumulating to a total of 4,500 shots across all targeted muscles in each session. The treatment will be administered twice a week for two consecutive weeks, resulting in a total of four treatment sessions.
干预措施: focused extracorporeal shock wave therapy (ESWT) (Device)
Placebo-Controlled Shockwave Therapy
Participants in this arm will receive placebo-controlled focused ESWT, mirroring the treatment protocol of the experimental group but without the application of active shockwaves.
干预措施: focused extracorporeal shock wave therapy (ESWT) (Device)
结局指标
主要结局
Visual Analogue Scale (VAS)
时间窗: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
individuals rate their pain from 0 to 10, where 0 represents 'no pain' and 10 signifies 'the worst pain imaginable
hand grip strength
时间窗: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
use dynamometer to record the maximum force applied when the patient squeezes it
passive range of motion for the wrist and finger joints
时间窗: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
the extent to which a joint can be moved without the patient actively participating in the movement
modified Ashworth scale (MAS)
时间窗: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Evaluate spasticity in individuals with neurological conditions. The scale ranges from 0, indicating no increase in muscle tone, to 4, which represents severe spasticity with affected parts rigid in flexion or extension.
modified Tardieu scale (MTS)
时间窗: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
A standard goniometer will be utilized to measure R2 and R1. The patient will be in testing position according to the muscle to be tested. The stretching velocity of V1 and V3 will be applied to measure R2 and R1, respectively. The quality of muscle reaction will be graded at the stretching velocity of V3 as well. The difference between R2 and R1 will be the measure of the dynamic component of spasticity. The minimum score on the MTS is 0 (no spasticity), and the maximum score is 5 (severe spasticity), for each of the velocities tested.
次要结局
- Functional Independence Measure (FIM)(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)
- Action Research Arm Test (ARAT)(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)
- ultrasound assessment(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)
- Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)
- Barthel index(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)
- Box and Block Test(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)
- Wolf Motor Function Test(pre-treatment; 1, 4, 12, and 24 weeks post-treatment)