Focused Shock Wave Therapy Before and After Botulinum Toxin Injection in Patients With Post-Stroke Spastic Equinus/Equinovarus Foot
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Change in spasticity assessed by the Modified Ashworth Scale (MAS)
研究概览
简要总结
Spastic equinovarus foot is the most common lower limb motor impairment after stroke and has a significant impact on gait, mobility, and quality of life. Botulinum toxin type A (BoNT-A) is considered the first-line treatment for focal post-stroke spasticity. Extracorporeal shock wave therapy (ESWT) has shown promising results as an adjunctive treatment; however, the optimal timing for its administration in combination with BoNT-A remains unknown.
This prospective, randomized, evaluator-blinded clinical trial aims to determine whether focal ESWT administered before or after BoNT-A injection is more effective than BoNT-A alone in patients with chronic post-stroke spastic equinovarus foot. Sixty-nine participants will be randomly allocated to one of three treatment groups: (1) BoNT-A alone; (2) one session of focal ESWT immediately before BoNT-A injection; or (3) one session of focal ESWT two weeks after BoNT-A injection. The primary outcome is spasticity measured with the Modified Ashworth Scale (MAS). Secondary outcomes include the Modified Tardieu Scale, passive ankle range of motion, muscle strength (MRC), 10-Meter Walk Test (10MWT), Functional Ambulation Classification (FAC), pain (VAS), Patient-Specific Assessment Scale (PSAS), muscle echogenicity using the Heckmatt scale, and muscle stiffness assessed by real-time elastography. Assessments will be performed at baseline and during follow-up through week 54.
详细描述
Stroke is one of the leading causes of long-term disability worldwide. Lower limb spasticity develops in a substantial proportion of stroke survivors, with the spastic equinovarus foot representing the most common gait pattern impairment. This condition negatively affects walking ability, balance, activities of daily living, and quality of life.
Botulinum toxin type A (BoNT-A) is considered the standard treatment for focal post-stroke spasticity. Nevertheless, its clinical effect is temporary and additional therapeutic strategies are needed to optimize and prolong treatment benefits. Extracorporeal shock wave therapy (ESWT) is a non-invasive intervention that has demonstrated beneficial effects on muscle tone, muscle stiffness, pain, and functional recovery. Experimental and clinical evidence suggests that ESWT may enhance the effects of BoNT-A, although the optimal timing of ESWT administration has not yet been established.
This study is a prospective, randomized, single-blind, three-arm clinical trial conducted at the Department of Physical and Rehabilitation Medicine of Hospital Clínico San Carlos (Madrid, Spain). Participants with chronic post-stroke spastic equinovarus foot who meet the eligibility criteria will be randomly assigned to one of three treatment groups:
Group A: BoNT-A injection alone.
Group B: One session of focal ESWT immediately before BoNT-A injection.
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 (Outcomes Assessor)
盲法说明
The outcome assessor will be blinded to treatment allocation throughout the study. Participants will be instructed not to disclose their assigned intervention during follow-up assessments. The healthcare provider administering the interventions and the participants will not be blinded.
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
- •Adults aged 18 to 87 years.
- •Clinical diagnosis of chronic stroke.
- •Presence of unilateral spastic equinovarus foot.
- •Lower-limb spasticity requiring treatment with botulinum toxin type A.
- •Ability to understand the study procedures and provide written informed consent.
排除标准
- •Botulinum toxin type A injection in the affected lower limb within the previous 12 weeks.
- •Previous extracorporeal shock wave therapy in the affected lower limb within the previous 12 weeks.
- •Fixed ankle contracture preventing passive correction.
- •Other neurological or musculoskeletal disorders affecting gait assessment.
- •Pregnancy or breastfeeding.
- •Contraindications to botulinum toxin type A or extracorporeal shock wave therapy.
- •Severe cognitive impairment preventing participation or informed consent.
- •Participation in another interventional clinical trial.
研究组 & 干预措施
Focal ESWT Before Botulinum Toxin Type A
Participants receive one session of focal extracorporeal shock wave therapy immediately before botulinum toxin type A (Botox®, onabotulinumtoxinA) injection into the spastic lower-limb muscles.
干预措施: Focal Extracorporeal Shock Wave Therapy (ESWT) (Device)
Focal ESWT After Botulinum Toxin Type A
Participants receive botulinum toxin type A (Botox®, onabotulinumtoxinA) injection into the spastic lower-limb muscles, followed by one session of focal extracorporeal shock wave therapy two weeks later.
干预措施: Focal Extracorporeal Shock Wave Therapy (ESWT) (Device)
Focal ESWT Before Botulinum Toxin Type A
Participants receive one session of focal extracorporeal shock wave therapy immediately before botulinum toxin type A (Botox®, onabotulinumtoxinA) injection into the spastic lower-limb muscles.
干预措施: Botulinum toxin type A (Drug)
Botulinum toxin type A alone
Participants assigned to the control group receive botulinum toxin type A (Botox®, onabotulinumtoxinA) alone, injected under ultrasound guidance into the spastic lower-limb muscles according to the study protocol. No extracorporeal shock wave therapy is administered.
干预措施: Botulinum toxin type A (Drug)
Focal ESWT After Botulinum Toxin Type A
Participants receive botulinum toxin type A (Botox®, onabotulinumtoxinA) injection into the spastic lower-limb muscles, followed by one session of focal extracorporeal shock wave therapy two weeks later.
干预措施: Botulinum toxin type A (Drug)
结局指标
主要结局
Change in spasticity assessed by the Modified Ashworth Scale (MAS)
时间窗: Baseline, 4, 12, 24, 28, 42 and 54 weeks.
Change in lower-limb spasticity measured using the Modified Ashworth Scale (MAS) after treatment.
次要结局
- Modified Tardieu Scale(Baseline, 4, 12, 24, 28, 42 and 54 weeks)
- Change in passive ankle dorsiflexion range of motion(Baseline, 4, 12, 24, 28, 42 and 54 weeks)
- Change in lower-limb muscle strength assessed by the Medical Research Council Scale(Baseline, 4, 12, 24, 28, 42 and 54 weeks)
- Change in gait speed assessed by the 10-Meter Walk Test(Baseline, 4, 12, 24, 28, 42 and 54 weeks)
- Change in muscle echogenicity assessed by the Heckmatt Scale(Baseline, 4, 12, 24, 28, 42 and 54 weeks)
- Change in pain intensity assessed by the Visual Analogue Scale(Baseline, 4, 12, 24, 28, 42 and 54 weeks)
- Change in patient-reported function assessed by the Patient-Specific Assessment Scale(Baseline, 4, 12, 24, 28, 42 and 54 weeks)
研究者
María Belén Martínez Luna
Consultant in Physical Medicine and Rehabilitation
Hospital San Carlos, Madrid