Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance:

Study Overview
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Brief Summary
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This study assess the relationship between lower limb spasticity and trunk movements during static and dynamic balance in post-stroke patients who also underwent conventional physical therapy, visual feedback balance training and radial extracorporeal shock wave therapy intervention.

Detailed Description
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The stabilometric assessment through Prokin system complemented the clinical evaluation and provided a more objective, global insight into the combined therapeutic effect. The stabilometric computerized system is both an assessment tool and a training system for static, dynamic balance and trunk. To date, it was used in various clinical trials as a training tool for promoting stance and balance improvement in several neurorehabilitation programs. Additional outcomes focused on the effectiveness on pain intensity, clonus, passive range of motion, lower limb sensorimotor function, and functionality. The adverse events were also attentively monitored during the trial.

Official Title
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Effectiveness of Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance: A Randomized Controlled Trial

Conditions
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Spastic Gait, Stroke, Ischemic, Stroke Hemorrhagic, Spasticity as Sequela of Stroke, Balance; Distorted

Intervention / Treatment
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* Other: radial extracorporeal shock wave therapy
* Other: sham radial extracorporeal shock wave therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a hemorrhagic or ischemic stroke in acute, subacute or chronic phase; no history of previous stroke; 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 unassisted in upright position for 30 seconds; no change in anti-spastic drug dose or treatment and no changes in analgesic medication, as it could affect the results on the Modified Ashworth Scale and the Visual Analogue Scale adult patients (>18 years old) Exclusion Criteria: other neurological and orthopaedic disorders or lower limb deformities that could in-terfere with motor performance and balance; myopathies; severe cognitive impairment, severe aphasia or inability to understand instructions; severe spasticity; visual field conditions or hemineglect; patients unable to undergo follow-up evaluation and excluded from the final analysis; anticoagulant medication or any contraindication to receive radial extracorporeal shockwave therapy (rESWT), or any contraindication to physical therapy.

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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional physiotherapy, visual feedback training, rESWT<br>conventional physiotherapy (5 times/week), visual feedback training (5 times/week), radial extracorporeal shock wave therapy (once/week for 2 weeks) | Other: radial extracorporeal shock wave therapy<br>* rESWT (Endopuls 811; Enraf Nonius B.V. Va-reseweg 127, 3047 AT Rotterdam MedTech, Wessling, Germany) will be applied on the myotendinous junction of both the gastrocnemius and the soleus muscles in post-stroke spasticity patients. 2000 shots will be applied on the gastrocnemius and soleus myotendinous junction with a frequency of 10 Hz and energy density of 60 mJ (1 bar) within tolerable pain limits.<br>|
| Sham Comparator: Conventional physiotherapy, visual feedback training, sham rESWT<br>conventional physiotherapy (5 times/week), visual feedback training (5 times/week), sham radial extracorporeal shock wave therapy (once/week for 2 weeks) | Other: sham radial extracorporeal shock wave therapy<br>* The control group will receive sound over the myotendinous junction of gastrocnemius and soleus with transducer-like contact.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spasticity grade change | The Modified Ashworth Scale (MAS) | Change from baseline Modified Ashworth Scale at 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion change | passive range of motion (PROM) parameter measured through a hand-held goniometer | Change from baseline Passive Range of Motion at 14 days | 
| Pain intensity change | Visual Analogue Scale (VAS) through a vertical 10-cm line (0 - starting pain-free to 10 - the worst imaginable pain). The higher the score means a worse outcome. | Change from baseline Visual Analogue Scale at 14 days | 
| Stabilometric outcomes change | Prokin system (PK 252, TecnoBody, Bergamo, Italy) parameters: trunk (degrees), stance (degrees), static (mm^2) and dynamic balance (mm^2) | Change from baseline Prokin system parameters at 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, spasticity, balance trainer, balance impairment, neurologic rehabilitation