NCT07695038尚未招募不适用
Effectiveness of Extracorporeal Shock Wave Therapy as an Adjunct to Botulinum Toxin Injection in Patients With Post-Stroke Ankle Plantar Flexor Spasticity: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change from Baseline in Muscle Spasticity Grade using the Modified Ashworth Scale (MAS)
研究概览
简要总结
The goal of this clinical trial is to learn if radial Extracorporeal Shock Wave Therapy (rESWT) is effective in reducing ankle plantar flexor spasticity and improving walking functions in stroke patients who have already received Botulinum Toxin type A (BoNT-A) injections. The main questions it aims to answer are:
- Does adding rESWT to standard physical therapy significantly lower muscle spasticity in patients who have received BoNT-A, compared to receiving physical therapy alone after the injection?
- Does combining rESWT with BoNT-A injection improve functional walking parameters (such as gait speed, cadence, and step length) and daily life independence more than the BoNT-A and physical therapy combination alone?
- Can rESWT induce additional structural and flexibility improvements in the BoNT-A injected gastrocnemius muscle, as measured objectively by ultrasound imaging and strain elastography?
Researchers will compare a group of participants receiving both rESWT and conventional physical therapy (Group 1) to a comparison group receiving only conventional physical therapy (Group 2) to see if rESWT provides additional clinical benefits. All participants in both groups will have already undergone routine BoNT-A injections one week prior to starting the study treatments.
Participants will:
- Undergo a 3-week conventional physical therapy and rehabilitation program, consisting of 2 to 3 hours of therapy per day, 5 days a week.
- Receive 3 weekly sessions of rESWT (2000 pulses per session applied to the calf muscles) if they are randomized into the rESWT group.
- Attend clinical evaluation visits and objective assessment sessions-including high-tech computerized gait analysis and specialized musculoskeletal ultrasound imaging-before the treatment, at the end of the 3rd week, and at a 12-week follow-up.
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)
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
- •Diagnosis of stroke according to the World Health Organization (WHO) (1989) definition.
- •Stroke diagnosis confirmed by magnetic resonance imaging (MRI).
- •Patients aged between 18 and 65 years.
- •Clinically stable condition after stroke.
- •Patients who have undergone routine Botulinum Toxin Type A (BoNT-A) injection to the gastrocnemius muscle.
- •Presence of ankle plantar flexor spasticity with a Modified Ashworth Scale (MAS) score of greater than or equal to 1 (MAS ≥ 1).
排除标准
- •Presence of fixed contracture at the ankle joint.
- •History of prior antispastic surgical procedures.
- •Changes in antispastic medication dosage or type within the last 6 months.
- •Active infection or malignancy at the application site.
- •Presence of a cardiac pacemaker.
- •Bleeding disorders or advanced vascular disease.
- •Pregnancy.
- •Presence of neuromuscular junction disease or motor neuron disease.
- •Known allergy or hypersensitivity to Botulinum Toxin Type A.
- •Current use of antibiotics.
结局指标
主要结局
Change from Baseline in Muscle Spasticity Grade using the Modified Ashworth Scale (MAS)
时间窗: Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
The MAS is a clinical scale used to assess resistance to passive movement in a joint affected by spasticity. Scores range from 0 to 4 (with an additional 1+ score), where 0 indicates no increase in muscle tone and 4 indicates the affected part is rigid in flexion or extension. Higher scores represent greater muscle spasticity.
次要结局
- Change from Baseline in Passive Ankle Dorsiflexion Range of Motion (ROM)(Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up))
- Change from Baseline in Activities of Daily Living Using the Modified Barthel Index (MBI)(Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up))
- Change from Baseline in Lower Extremity Motor Function Using the Fugl-Meyer Assessment Lower Extremity (FMA-LE)(Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up))
- Change from Baseline in Muscle Fibrotic Alterations Using the Modified Heckmatt Scale(Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up))
- Change from Baseline in Muscle Stiffness Using Sonoelastography Strain Index (SI)(Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up))
- Change from Baseline in Muscle Stiffness Using Sonoelastography Strain Ratio (SR)(Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up))
- Change from Baseline in Walking Velocity Using Rehawalk Computerized Analysis(Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up))
- Change from Baseline in Cadence Using Rehawalk Computerized Analysis(Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up))
- Change from Baseline in Step Width Using Rehawalk Computerized Analysis(Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up))
- Change from Baseline in Single-Support Phase Duration Using Rehawalk Computerized Analysis(Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up))
- Change from Baseline in Double-Support Phase Duration Using Rehawalk Computerized Analysis(Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up))
- Change from Baseline in Stride Length Using Rehawalk Computerized Analysis(Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up))
- Change from Baseline in Temporal Gait Symmetry Index (TGSI) Using Rehawalk Computerized Analysis(Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up))
研究者
Meltem Gunes Akinci
Principal Investigator
Pamukkale University
研究点 (1)
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