Comparison of Extracorporeal Shock Wave to Different Muscle Targets in Post-Stroke Spasticity of Ankle Plantar Flexor

Study Overview
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Brief Summary
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Post-stroke spasticity is a common complication affecting the neurological recovery, self-care daily activities and patients' quality of life. Extracorporeal shock waves (ESWT) have been proven therapeutic effects on decreasing spasticity and regaining function. Stroke patients often suffer ankle plantar flexor spasticity with poor ankle movement control, leading to abnormal gait patterns and risk of falling; local pain appears as well in the ankle. Research showed application of ESWT to lower extremity spasticity reduced ankle plantar flexor spasticity, ankle pain and increased the range of ankle motion. However, the current study did not investigate the effect of ESWT on different muscles in patients with post-stroke ankle spasticity. Therefore, this study will compare the effect of focused ESWT on combination of the gastrocnemius and soleus muscles to gastrocnemius muscle alone in the post-stroke ankle plantar flexor spasticity.

Detailed Description
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This study design was a single-blind randomized controlled trial and planned to recruit 40 chronic stroke patients with ankle plantar flexor spasticity. The patients were randomly assigned to two groups. The experimental group received focused ESWT to gastrocnemius and soleus muscles (2000 shots for each muscle, a total of 4000 shots per session), while the control group received focused ESWT to gastrocnemius muscle (2000 shots per session). Patients in both groups underwent a total of 4 sessions ESWT, twice a week for two consecutive weeks. The depths of ESWT to gastrocnemius and soleus muscle were determined by ultrasound. All patients received traditional rehabilitation. The primary outcome was modified Ashworth scale; the secondary outcomes were modified Tardieu scale, passive range of ankle motions and timed up and go test, and ultrasound evaluations (pennation angle and strain elastography of muscles). The outcomes were assessed before ESWT and after ESWT at 1, 4, 12, and 24 week.

Official Title
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Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital Hsin-Chu Branch, Hsinchu, Taiwan

Conditions
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Stroke

Intervention / Treatment
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* Device: Extracorporeal shock waves


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject with Cerebral stroke and age more 20 The degree of spasticity of plantar flexor is more than 1.( grading with the modified Ashworth scale) Stable vital sign Exclusion Criteria: Recurrent cerebral stroke, traumatic brain injury, brain tumor or other brain related disease. Other central nervous system diseases (SCI, Parkinson's disease), or other musculoskeletal disorders which affect the result of evaluating muscle spasticity. Malignant tumor, coagulation disorder, infection or use of pace which were not suitable for Extracorporeal Shock Wave. Received Extracorporeal Shock Wave or Botulinum injection for plantar flexor spasticity in recent 3 months. Subjects who was unable to complete Extracorporeal Shock Wave or evaluation due to impaired cognition or aphasia.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESWT to gastrocnemius and soleus<br>ESWT to gastrocnemius and soleus muscles (2000 shots for each muscle, a total of 4000 shots per session) | Device: Extracorporeal shock waves<br>* Both group received extracorporeal shock waves therapy<br>|
| Active Comparator: ESWT to gastrocnemius<br>ESWT to gastrocnemius muscle (2000 shots per session) | Device: Extracorporeal shock waves<br>* Both group received extracorporeal shock waves therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Modified Ashworth Scale (MAS) | Modified Ashworth Scale (MAS). Score from 0 to 4, higher scores mean a worse outcome | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 | 
| Change in modified Tardieu scale (mTS) | Modified Tardieu scale (mTS). Score from 0 to 5, higher scores mean a worse outcome | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 | 
| Change in Passive ROM of the ankle in dorsiflexion | Passive ankle Range of Motion (p-ROM) | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Level of mobility and balance | Timed Up & Go Test | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 | 
| Ultrasound evaluations | Pennation angle of muscles | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 | 
| Ultrasound evaluations | Strain elastography of gastrocnemius muscle | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, spasticity, shock wave, ankle