Effectiveness of Shock Wave Therapy for Upper Limb Spasticity

Study Overview
=================
Brief Summary
-----------------
Introduction: Shock wave therapy (SWT) has a potential interest to treat spasticity. However, the pathophysiology of this treatment remains unknown. Some authors assert that it is effective on spasticity itself, while others suggest that it acts more on fibrosis. Method: this study will assess the effectiveness of radial SWT to treat wrist and finger flexors stiffness in stroke patients, comparing subacute spastic patients (< 12 months) with chronic patients presenting muscle contractures (> 12 months). Forty-eight stroke patients (24 in the subacute phase and 24 in the chronic phase) will be included. One real and one sham sessions of SWT will be performed with a 2-week interval. The order of the sessions will be randomized. Motor control, stiffness and spasticity will be assessed with clinical and objective measures, just after and just before each session, by a blind assessor. The targeted muscles will be flexor carpi radialis, flexor carpi ulnaris and flexor digitorum profundus, and will be the same for the two session.

Official Title
-----------------
Effectiveness of Shock Wave Therapy to Treat Upper Limb Spasticity in Hemiparetic Patients

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: shock wave therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of cerebral lesion Wrist spasticity ≥ 1+/4 on the Modified Ashworth Scale Wrist spasticity ≥ 2/4 on the Tardieu Scale Passive dorsal extension of the wrist ≥ 10° Exclusion Criteria: Botulinum toxin injection in the upper limb in the past three months History of wrist arthrodesis Myopathy Treatment with oral anticoagulants or coagulation disease Tumor or infection of the paretic upper limb

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: interventional group<br>group receiving shock wave therapy | Device: shock wave therapy<br>* Shockwave therapy is a non-invasive treatment creating a series of low energy acoustic wave pulsations that are directly applied through the skin via a gel medium<br>|
| Sham Comparator: control group<br>sham shock wave therapy | Device: shock wave therapy<br>* Shockwave therapy is a non-invasive treatment creating a series of low energy acoustic wave pulsations that are directly applied through the skin via a gel medium<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale | Clinical assessment of spasticity for wrist and fingers flexors, score from 0 to 4 (a higher score representing a greater spasticity) | Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT) | 
| Tardieu scale | Clinical assessment of spasticity for wrist and fingers flexors; score from 0 to 4 (a higher score representing a greater spasticity) | Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective measure of elastic and viscous stiffness of the wrist, expressed in N.m.rad | electronic oscillatory device for stiffness measurement | Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT) | 
| objective measure of muscle stiffness | Myoton measurement device | Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT) | 
| manual goniometer | Passive measure of joint range of motion | Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT) | 
| Medical Research Council muscle testing | strength assessment; score from 0 to 5 (a higher score representing a greater strength) | Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT) | 
| Isokinetic dynamometer | objective measure of muscle stiffness at the wrist | Before (baseline) and 15 minutes (post-treatment) after each of the two sessions (sham or real SWT) | 
| H reflex | electrophysiological assessment of the H reflex (motoneuronal excitability) | Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT) | 
| Box and block test | measure of manual ability | Before (baseline) and 30 minutes (post-treatment) after each of the two sessions (sham or real SWT) | 
| Fugl Meyer Assessment - computerized adaptive testing | neurological impairment | Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT) | 
| Abilhand scale | PROMS on bimanual activities; a higher score represents a better manual ability | Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT) | 
| Wolff Motor Function Test | manual activities | Before (baseline) and 35 minutes (post-treatment) after each of the two sessions (sham or real SWT) | 
| Visual Analog Scale | patient self-assessment of overall effectiveness of SWT; score from 0 to 4 (a higher score representing a greater improvement) | Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT) |