Stroke
Conditions
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.
Interventions
DEVICEshock wave therapy
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
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Ashworth Scale | Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT) | Clinical assessment of spasticity for wrist and fingers flexors, score from 0 to 4 (a higher score representing a greater spasticity) |
| Tardieu scale | Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT) | Clinical assessment of spasticity for wrist and fingers flexors; score from 0 to 4 (a higher score representing a greater spasticity) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective measure of elastic and viscous stiffness of the wrist, expressed in N.m.rad | Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT) | electronic oscillatory device for stiffness measurement |
| objective measure of muscle stiffness | Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT) | Myoton measurement device |
| manual goniometer | Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT) | Passive measure of joint range of motion |
| Medical Research Council muscle testing | Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT) | strength assessment; score from 0 to 5 (a higher score representing a greater strength) |
| Isokinetic dynamometer | Before (baseline) and 15 minutes (post-treatment) after each of the two sessions (sham or real SWT) | objective measure of muscle stiffness at the wrist |
| H reflex | Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT) | electrophysiological assessment of the H reflex (motoneuronal excitability) |
| Box and block test | Before (baseline) and 30 minutes (post-treatment) after each of the two sessions (sham or real SWT) | measure of manual ability |
| Fugl Meyer Assessment - computerized adaptive testing | Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT) | neurological impairment |
| Abilhand scale | Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT) | PROMS on bimanual activities; a higher score represents a better manual ability |
| Wolff Motor Function Test | Before (baseline) and 35 minutes (post-treatment) after each of the two sessions (sham or real SWT) | manual activities |
| Visual Analog Scale | Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT) | patient self-assessment of overall effectiveness of SWT; score from 0 to 4 (a higher score representing a greater improvement) |
Countries
Belgium
Contacts
Primary ContactGaëtan Stoquart, MD PhD
Backup ContactClara Selves, MD
Outcome results
None listed