THE EFFECTS OF EXTRACORPOREAL SHOCK WAVE THERAPY ON UPPER EXTREMITY SPASTICITY AND FUNCTION IN PATIENTS WITH STROKE: A SINGLE-ARM STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change from baseline in upper extremity spasticity
研究概览
简要总结
Stroke is a leading cause of adult disability worldwide. Among its most functionally limiting complications is upper extremity spasticity - a velocity-dependent increase in muscle tone that restricts arm and hand function, impairs daily activities, and reduces quality of life. Current treatment options such as oral antispastic agents and botulinum toxin injections are associated with systemic side effects, high cost, invasiveness, or short duration of effect.
Radial extracorporeal shock wave therapy (rESWT) is a non-invasive modality that delivers acoustic pressure waves to target tissues and has shown promising antispastic effects through both neural and biomechanical mechanisms.
This prospective observational study (N=21) evaluates the effects of upper extremity rESWT on spasticity, pain, motor function, functional independence, and quality of life in individuals with post-stroke hemiplegia. rESWT was applied to three muscle groups (biceps brachii, flexor carpi radialis, and flexor carpi ulnaris) at 2,000 impulses per muscle, 5 Hz, 1.5 bar, twice weekly for 4 weeks (8 sessions total). Outcomes were assessed at three time points: baseline, month 1, and month 3.
详细描述
Stroke ranks first among causes of adult disability and second among causes of mortality worldwide. Post-stroke spasticity develops in 4% to 50% of patients within the first six months after stroke, depending on lesion localization and timing of assessment. In the upper extremity, spasticity typically manifests as shoulder adduction and internal rotation, elbow flexion, forearm pronation, and wrist/finger flexion severely limiting functional use of the hand and arm. Associated pain, spasms, and joint contractures further reduce quality of life and rehabilitation motivation.
Conventional antispastic treatments carry notable limitations: oral agents produce sedation and generalized muscle weakness; botulinum toxin injections are costly, invasive, limited in duration, and carry a risk of neutralizing antibody development with repeated use. These limitations have prompted growing interest in rESWT as a non-invasive, low-side-effect alternative with multifactorial antispastic mechanisms, including modulation of motor neuron excitability, improvement of passive muscle elasticity through fibrolytic effects, and facilitation of autogenic inhibition via Golgi tendon organ stimulation.
Study Design: Single-arm prospective observational study. Approved by the Ethics Committee of Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital (Decision No: 2025/214; Date: 11.06.2025). All procedures were conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants.
Participants (N=21): Adults (≥18 years) with post-stroke hemiplegia of at least 4 weeks duration, Modified Ashworth Scale (MAS) score ≥2 in at least one upper extremity joint movement, and sufficient cognitive ability to follow simple commands.
Exclusion criteria included consciousness impairment, systemic contraindications to ESWT, shoulder subluxation on the affected side, skin integrity disruption at the application site, and botulinum toxin injection within the preceding 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age 18 years or older
- •Diagnosis of hemiplegia following stroke
- •Minimum of 4 weeks elapsed since stroke onset
- •Modified Ashworth Scale (MAS) score ≥ 2 in at least one upper extremity joint movement
- •Sufficient cognitive ability to follow simple commands
- •No botulinum toxin injection in the preceding 3 months
- •Willing to participate and signed informed consent form
排除标准
- •Impaired consciousness or severe cognitive deficit
- •Systemic conditions contraindicating ESWT (active infection, malignancy, etc.)
- •Shoulder subluxation on the affected side
- •Skin integrity disruption at the application site
研究组 & 干预措施
Radial Extracorporeal Shock Wave Therapy (rESWT)
Participants received radial extracorporeal shock wave therapy applied to three muscle groups of the affected upper extremity (biceps brachii, flexor carpi radialis, and flexor carpi ulnaris) at 2,000 impulses per muscle group, 5 Hz frequency, and 1.5 bar pressure, twice weekly for 4 weeks (8 sessions total)
干预措施: Radial Extracorporeal Shock Wave Therapy (rESWT) (Device)
结局指标
主要结局
Change from baseline in upper extremity spasticity
时间窗: Baseline, at 4 weeks and 12 weeks follow-up
Spasticity will be assessed using the Modified Ashworth Scale (MAS). Passive resistance is graded on a 0-4 ordinal scale across seven upper extremity movements: elbow flexion/extension, forearm pronation/supination, wrist flexion/extension, and finger flexion. Higher scores indicate greater spasticity.
Change from baseline in upper extremity motor function
时间窗: Baseline, at 4 weeks and 12 weeks follow-up
Assessed using the Fugl-Meyer Upper Extremity Scale (FMA-UE), a 33-item scale scoring voluntary movement, reflexes, coordination, and independent joint motion.
次要结局
- Change from baseline in functional independence(Baseline, at 4 weeks and at 12 weeks follow-up)
- Change from baseline in pain intensity(Baseline, at 4 weeks and at 12 weeks follow-up)
- Change from baseline in stroke-specific quality of life(Baseline, at 4 weeks and at 12 weeks follow-up)
- Change from baseline in depressive symptom severity(Baseline, at 4 weeks, and at 12 weeks follow-up)
- Change from baseline in proprioception(Baseline, at 4 weeks and at 12 weeks follow-up)