Effectiveness of Shock Wave Therapy for Upper Limb Spasticity

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04316026
• Other study ID #: 2019/27MAR/151
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: June 2024

Study information

• Verified date: April 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Gaëtan Stoquart, MD PhD
• Phone: +3227641650
• Email: gaetan.stoquart[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke

Intervention

Device:
• shock 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

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Wolff Motor Function Test	manual activities	Before (baseline) and 35 minutes (post-treatment) after each of the two sessions (sham or real SWT)
Secondary	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)