Radial Shock Waves for Functional Disability in Stroke

Study Overview
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Brief Summary
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This is a double blind randomized clinical trial to evaluate the effect of radial shock waves on functional recovery of the upper limb of patients with sequelae of ischemic strokes in the territory of the middle cerebral artery. A total of 20 patients will be enrolled and will undergo motor, functional and cortical excitability evaluations before and after four weekly sessions of radial shockwaves. 5,000 pulses with a frequency of 15 Hz and 3.5 to 4 bar of air pressure will be applied to the active group, resulting in an energy flux density (EFD) of approximately 0.07 mJ/mm2. The sham group will receive identical treatment, except for the fact that no energy flux will be applied.

Official Title
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Effect of Radial Shock Waves for the Treatment of Upper Limb Functional Disability in Stroke Sequelae

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: Active Radial Shockwave
* Device: Sham Radial Shockwave


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical and radiological diagnosis: Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan indicating Stroke in the territory of the middle cerebral artery; 6 to 24 months after stroke date; Stability observed in clinical medical evaluation Granting of written informed consent to participate in the study Exclusion Criteria: Individuals with a score lower than 24 on the Mini-mental test; Previously documented strokes Pregnancy Patients treated with botulinum toxin, phenol, alcohol or previous surgeries six months before entering the study Bone diseases, pre-existing joint damage, and deformities affecting the patient in a way to interfere with implementation of the proposed therapy Psycho-affective disorder that prevents adherence Joint pain that occurs within the movement range of therapies

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Radial Shockwave<br>Every patient will receive 5,000 continuous pulses per treatment session, at 3.5 to 4 bar air pressure (resulting in an energy flux density [EFD] of approximately 0.07 mJ/mm2) and at 15Hz frequency. A total of 4 sessions will be performed. | Device: Active Radial Shockwave<br>* Four weekly sessions of active radial shockwave treatment.<br>|
| Sham Comparator: Sham Radial Shockwave<br>Every patient will receive 5,000 continuous pulses per treatment session, without air pressure (resulting in no EFD) and at 15Hz frequency. A total of 4 sessions will be performed. | Device: Sham Radial Shockwave<br>* Four weekly sessions of sham radial shockwave treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment (FMA) | Mean change in Fugl Meyer Assessment score after four sessions of Radial Shockwave Therapy (RSWT) as compared to baseline. | Change from baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | Multiple changes in VAS | Baseline, one and two months | 
| Esthesiometry - Von Frey Scale | Multiple changes in Von Frey Scale | Baseline, one and two months | 
| Upper Limb Modified Ashworth Scale (MAS) | Multiple changes in MAS | Baseline, one week, two weeks, three weeks, four weeks and two months | 
| Fugl-Meyer Assessment | Changes in Fugl-Meyer Assessment compared to baseline | Baseline and two months | 
| Medical Research Council scale (MRC) | Multiple changes in MRC scale | Baseline, one and two months | 
| Hand grip | Multiple changes in Hand grip | Baseline, one and two months | 
| Change in fine motor function measured with Finger Tapping (FT) | Multiple changes in FT | Baseline, one and two months | 
| Jebsen-Taylor Hand Function Test (JTHFT) | Multiple changes in JTHFT | Baseline, one and two months | 
| Purdue Pegboard Test (PPBT) | Multiple changes in PPBT | Baseline, one and two months | 
| Robotic kinematic evaluation (RKE) | Multiple changes in RKE | Baseline, one and two months | 
| Corticospinal excitability measures with transcranial magnetic stimulation (TMS) | Multiple changes in Corticospinal excitability | Baseline, one and two months | 
| Pinch strength testing | Pinch strength testing | Baseline, one and two months |