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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| interventional group | Experimental | group receiving shock wave therapy |
|
| control group | Sham Comparator | sham shock wave therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| shock wave therapy | Device | 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 |
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gaƫtan Stoquart, MD PhD | Contact | +3227641650 | gaetan.stoquart@uclouvain.be | |
| Clara Selves, MD | Contact | +3227641650 | clara.selves@uclouvain.be |
| Name | Affiliation | Role |
|---|---|---|
| Gaƫtan Stoquart, MD, PhD | Cliniques universitaires Saint-Luc- UniversitƩ Catholique de Louvain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Recruiting | Brussels | 1200 | Belgium |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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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) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |