Clinical trial NCT04316026: Effectiveness of Shock Wave Therapy for Upper Limb Spasticity
Official title: Effectiveness of Shock Wave Therapy to Treat Upper Limb Spasticity in Hemiparetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
measure: Tardieu scale
timeFrame: Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Secondary outcomes:
measure: objective measure of elastic and viscous stiffness of the wrist, expressed in N.m.rad
timeFrame: Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
measure: objective measure of muscle stiffness
timeFrame: Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT)
measure: manual goniometer
timeFrame: Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT)
measure: Medical Research Council muscle testing
timeFrame: Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT)
measure: Isokinetic dynamometer
timeFrame: Before (baseline) and 15 minutes (post-treatment) after each of the two sessions (sham or real SWT)
measure: H reflex
timeFrame: Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)
measure: Box and block test
timeFrame: Before (baseline) and 30 minutes (post-treatment) after each of the two sessions (sham or real SWT)
measure: Fugl Meyer Assessment - computerized adaptive testing
timeFrame: Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT)
measure: Abilhand scale
timeFrame: Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT)
measure: Wolff Motor Function Test
timeFrame: Before (baseline) and 35 minutes (post-treatment) after each of the two sessions (sham or real SWT)
measure: Visual Analog Scale
timeFrame: Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Gaëtan Stoquart, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: