Efficacy of Extracorporeal Shock Wave Therapy on Spasticity, Mobility, Motor Function, and Health-Related Quality of Life in Stroke Survivors: A Prospective Randomized Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 85
- 主要终点
- Change in Spasticity Assessed by Modified Ashworth Scale (MAS)
研究概览
简要总结
This study aims to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) in individuals with lower limb spasticity following stroke. Spasticity is a common complication after stroke and can negatively affect walking ability, mobility, and quality of life.
Participants will be randomly assigned to one of two groups. Both groups will receive a standard physiotherapy and rehabilitation program. In addition, the intervention group will receive ESWT applied to the lower limb muscles, while the control group will receive a sham (placebo) ESWT application.
The treatment program will be conducted three times per week for four weeks. Clinical assessments will be performed at baseline, after treatment, and during follow-up.
The main outcomes of the study include muscle tone (spasticity), walking performance, motor function, and quality of life. The results of this study may help improve rehabilitation strategies and provide evidence for the use of ESWT in stroke patients.
详细描述
Stroke is one of the leading causes of long-term disability worldwide and is frequently associated with motor impairments, including spasticity. Post-stroke spasticity is characterized by increased muscle tone, exaggerated tendon reflexes, and resistance to passive movement, which can significantly impair functional mobility, gait performance, and independence in daily activities. Lower limb spasticity, particularly involving the plantar flexor muscles, plays a critical role in limiting walking ability and increasing the risk of falls.
Conventional treatment approaches for spasticity include physiotherapy interventions, oral medications, and botulinum toxin injections. However, these methods may have limited effectiveness, potential side effects, or high costs. Therefore, there is a need for alternative, non-invasive, and effective treatment options.
Extracorporeal shock wave therapy (ESWT) has recently emerged as a promising non-invasive modality for the management of spasticity. ESWT is thought to reduce muscle tone by altering muscle viscoelastic properties, modulating neuromuscular transmission, and improving local blood circulation. Previous studies have suggested beneficial effects of ESWT on spasticity; however, evidence regarding its impact on functional outcomes such as gait performance and quality of life remains limited and inconsistent.
This study is designed as a prospective, randomized, single-blind, sham-controlled clinical trial conducted at a tertiary rehabilitation center. A total of 85 participants with chronic stroke (≥3 months) and lower extremity spasticity (Modified Ashworth Scale ≥1+) will be recruited. Participants will be randomly assigned to either the ESWT group or the control group using a block randomization method.
The intervention group will receive radial ESWT applied to the gastrocnemius and soleus muscles in addition to a standard physiotherapy program. The ESWT parameters will include an energy flux density of 0.10-0.20 mJ/mm², frequency of 5-8 Hz, and 2000-3000 pulses per muscle, administered three times per week for four weeks. The control group will receive sham ESWT with identical procedures but without therapeutic energy delivery. Both groups will undergo a standardized rehabilitation program consisting of stretching, strengthening, balance training, and gait training.
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)
盲法说明
This study is designed as a single-blind trial. Participants will be blinded to group allocation through the use of sham ESWT in the control group. Outcome assessors will also be blinded to the intervention groups. The therapist delivering the treatment will not be blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years
- •Diagnosed with ischemic or hemorrhagic stroke at least 3 months prior to enrollment Presence of lower extremity spasticity with a Modified Ashworth Scale (MAS) score ≥1+
- •Ability to walk independently with or without assistive devices
- •Ability to understand and follow instructions for exercise interventions and assessments
- •Provided written informed consent
排除标准
- •Receipt of botulinum toxin injection in the affected lower limb within the last 3 months
- •Severe cognitive impairment preventing participation in assessments
- •Presence of fixed joint contractures limiting range of motion
- •Orthopedic or musculoskeletal disorders affecting lower limb function (e.g., fracture, severe osteoarthritis)
- •Uncontrolled cardiovascular, respiratory, or systemic disease contraindicating exercise
- •Participation in another interventional clinical trial
- •Any condition judged by the investigator to interfere with participation or safety
研究组 & 干预措施
Control Group (Sham ESWT)
Participants in this group will receive sham ESWT with no therapeutic energy delivery in addition to the same standard physiotherapy program.
干预措施: Sham Extracorporeal Shock Wave Therapy (Device)
ESWT Group
Participants in this group will receive extracorporeal shock wave therapy (ESWT) applied to the gastrocnemius and soleus muscles in addition to a standard physiotherapy program including stretching, strengthening, balance, and gait training.
干预措施: Extracorporeal Shock Wave Therapy (ESWT) (Device)
结局指标
主要结局
Change in Spasticity Assessed by Modified Ashworth Scale (MAS)
时间窗: Baseline, 4 weeks (post-treatment), and 8 weeks (follow-up)
Spasticity will be assessed using the Modified Ashworth Scale (MAS), a 6-point ordinal scale ranging from 0 (no increase in muscle tone) to 4 (rigidity). The assessment will be performed on the ankle plantar flexor muscles. A decrease in MAS score indicates improvement in spasticity. Spasticity will be assessed using the Modified Ashworth Scale (MAS), a 6-point ordinal scale ranging from 0 to 4, where: 0 = No increase in muscle tone 1 = Slight increase in muscle tone 1+ = Minimal resistance through less than half of the range 2 = More marked increase in tone 3 = Considerable increase in tone 4 = Rigid in flexion or extension The assessment will be performed on the ankle plantar flexor muscles. Higher scores indicate greater spasticity (worse outcome), while lower scores indicate improvement.
次要结局
- Change in Walking Speed Assessed by 10-Meter Walk Test (10MWT)(Baseline, 4 weeks, 8 weeks)
- Change in Functional Mobility Assessed by Timed Up and Go Test (TUG)(Baseline, 4 weeks, 8 weeks)
- Change in Motor Function Assessed by Fugl-Meyer Assessment - Lower Extremity (FMA-LE)(Baseline, 4 weeks, 8 weeks)
- Change in Functional Exercise Capacity Assessed by 6-Minute Walk Test (6MWT)(Baseline, 4 weeks, 8 weeks)
- Change in Health-Related Quality of Life Assessed by Stroke-Specific Quality of Life Scale (SS-QOL)(Baseline, 4 weeks, 8 weeks)
研究者
salih tan
Assistant Professor
Istanbul Medipol University Hospital