Extracorporeal Shock Wave Therapy and Assessment Strategy Through a Novel Gait Analysis Tool for Post-stroke Spasticity

Study Overview
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Brief Summary
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The aim of this study is to objectively evaluate the effectiveness of radial extracorporeal shock wave therapy (rESWT) and conventional physical therapy program on the gait pattern through a new gait analysis system which encompasses spatiotemporal and kinematic parameters and to correlate the findings with the clinical evaluation.

Detailed Description
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The aim of this observational study was to objectively evaluate the effects of radial extracorporeal shock wave therapy and conventional physical therapy program on the gait pattern, spatiotemporal variables (step length, step cycle time, stance foot flexion-extension, foot stance pronation-supination, and foot swing flexion-extension), and kinematic parameters (trunk flexion-extension, trunk lateral flexion, hip flexion-extension, knee flexion-extension, ankle flexion-extension) through a new gait analysis system and correlate the findings with clinical outcomes such as Modified Ashworth scale (MAS), passive range of motion (PROM), Clonus score, Visual Analogue Scale (VAS), Tinetti Assessment Tool, Functional Ambulation Categories (FAC). The gait pattern of post-stroke patients before and after rESWT delivery and conventional rehabilitation program will be assessed clinically and also through an instrumented treadmill (Walker View) in terms of spatiotemporal and kinematic gait parameters.

Official Title
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Efficacy of Extracorporeal Shock Wave Therapy and Assessment Strategy Through a Novel Gait Analysis Tool for Post-stroke Spasticity During COVID-19 Pandemic

Conditions
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Stroke, Ischemic, Stroke Hemorrhagic, Spasticity, Muscle, Spastic Gait

Intervention / Treatment
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* Other: Radial extracorporeal shock wave therapy and conventional physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: suffered from a hemorrhagic or ischemic stroke and they were in the subacute or chronic phase; had no history of previous stroke; had lower limb post- stroke spasticity and spasticity grade ≥1 on the Modified Ashworth Scale (MAS); pain intensity measured on Visual Analogue Scale (VAS) ≥1; ability to stand and walk unassisted for at least 30 seconds; adult patients (>18 years old). Exclusion Criteria: other neurological, musculoskeletal, orthopaedic, or cardiovascular conditions; -- severe cognitive impairment, severe aphasia or inability to understand or execute instructions; changes in antispastic medication and dose or changes in the analgesic medication; myopathy; severe spasticity grade; visual field disorders or hemineglect; anticoagulants or any contraindication to receive radial extracorporeal shock wave therapy (rESWT), or any contraindication to receive physical therapy sessions.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>The patients considered eligible will form the study group and will start the conventional physical therapy program and radial extracorporeal shock wave therapy delivery (rESWT). | Other: Radial extracorporeal shock wave therapy and conventional physical therapy<br>* The conventional physical therapy program will consist of verticalization strategies, range of motion exercises, muscle stretching and strengthening exercises, stance and balance training, core stability exercises, gait training, functional training, cryotherapy or local heat for 1h/day, 5 days/week for 2 weeks. Regarding the rESWT delivery, 2000 shots will be applied on the triceps surae myotendinous junction with a frequency of 10 Hz and an energy density of 60 mJ, 7 min/session, 1 session/week for 2 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spasticity grade change | Modified Ashworth Scale (MAS); ranges from 0 (no increase in muscle tone) to 5 (rigid limb in flexion or extension). The lower the score, the lower spasticity grade, thus a better outcome. | Change from baseline Modified Ashworth Scale at 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle passive range of motion change | Passive range of motion (PROM); flexion 0-30 degrees, extension 0-50 degrees, pronation 0-30 degrees, supination 0-60 degrees. Higher scores define augmented, better range of motion. | Change from baseline Passive Range of Motion at 14 days | 
| Pain intensity change | Visual Analogue Scale (VAS); the greater the value on the 0.1 meters line, the greater the pain intensity starting from 0 (no pain at all) to 10 (the highest pain intensity ever experienced). | Change from baseline Visual Analogue Scale at 14 days | 
| Step length change | Step length (meters); ranges from 0-0.5 meters, the higher the step length leads to better outcome. | Change from baseline step length at 14 days | 
| Knee flexion-extension change | Knee flexion-extension; Maximum and minimum angle value in the sagittal plane of knee, from 0 degrees in full extension to 140-150 degrees in maximum flexion. | Change from baseline knee flexion-extension at 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, spasticity, neurological rehabilitation, radial extracorporeal shock wave therapy, gait analysis system