Effectiveness of Shock Wave Therapy for Upper Limb Spasticity
- Conditions
- Stroke
- Interventions
- Device: shock wave therapy
- Registration Number
- NCT04316026
- Lead Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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°
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description control group shock wave therapy sham shock wave therapy interventional group shock wave therapy group receiving shock wave therapy
- Primary Outcome Measures
Name Time Method 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)
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)
- Secondary Outcome Measures
Name Time Method 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
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
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)
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
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)
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
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)
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
Wolff Motor Function Test Before (baseline) and 35 minutes (post-treatment) after each of the two sessions (sham or real SWT) manual activities
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
Trial Locations
- Locations (1)
Cliniques universitaires Saint-Luc
🇧🇪Brussels, Belgium