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Effectiveness of Shock Wave Therapy for Upper Limb Spasticity

Primary Purpose

Stroke

Status

Recruiting

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

shock wave therapy

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cliniques universitaires Saint-LucRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

interventional group

control group

Arm Description

group receiving shock wave therapy

sham shock wave therapy

Outcomes

Primary Outcome Measures

Modified Ashworth Scale

Clinical assessment of spasticity for wrist and fingers flexors, score from 0 to 4 (a higher score representing a greater spasticity)

Tardieu scale

Clinical assessment of spasticity for wrist and fingers flexors; score from 0 to 4 (a higher score representing a greater spasticity)

Secondary Outcome Measures

objective measure of elastic and viscous stiffness of the wrist, expressed in N.m.rad

electronic oscillatory device for stiffness measurement

objective measure of muscle stiffness

Myoton measurement device

manual goniometer

Passive measure of joint range of motion

Medical Research Council muscle testing

strength assessment; score from 0 to 5 (a higher score representing a greater strength)

Isokinetic dynamometer

objective measure of muscle stiffness at the wrist

H reflex

electrophysiological assessment of the H reflex (motoneuronal excitability)

Box and block test

measure of manual ability

Fugl Meyer Assessment - computerized adaptive testing

neurological impairment

Abilhand scale

PROMS on bimanual activities; a higher score represents a better manual ability

Wolff Motor Function Test

manual activities

Visual Analog Scale

patient self-assessment of overall effectiveness of SWT; score from 0 to 4 (a higher score representing a greater improvement)

Full Information

NCT ID

NCT04316026

First Posted

January 7, 2020

Last Updated

April 12, 2023

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT04316026

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 2, 2019 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

interventional group

Arm Type

Experimental

Arm Description

group receiving shock wave therapy

Arm Title

control group

Arm Type

Sham Comparator

Arm Description

sham shock wave therapy

Intervention Type

Device

Intervention Name(s)

shock wave therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Modified Ashworth Scale

Description

Clinical assessment of spasticity for wrist and fingers flexors, score from 0 to 4 (a higher score representing a greater spasticity)

Time Frame

Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)

Title

Tardieu scale

Description

Clinical assessment of spasticity for wrist and fingers flexors; score from 0 to 4 (a higher score representing a greater spasticity)

Time Frame

Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)

Secondary Outcome Measure Information:

Title

objective measure of elastic and viscous stiffness of the wrist, expressed in N.m.rad

Description

electronic oscillatory device for stiffness measurement

Time Frame

Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)

Title

objective measure of muscle stiffness

Description

Myoton measurement device

Time Frame

Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT)

Title

manual goniometer

Description

Passive measure of joint range of motion

Time Frame

Before (baseline) and 10 minutes (post-treatment) after each of the two sessions (sham or real SWT)

Title

Medical Research Council muscle testing

Description

strength assessment; score from 0 to 5 (a higher score representing a greater strength)

Time Frame

Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT)

Title

Isokinetic dynamometer

Description

objective measure of muscle stiffness at the wrist

Time Frame

Before (baseline) and 15 minutes (post-treatment) after each of the two sessions (sham or real SWT)

Title

H reflex

Description

electrophysiological assessment of the H reflex (motoneuronal excitability)

Time Frame

Before (baseline) and 5 minutes (post-treatment) after each of the two sessions (sham or real SWT)

Title

Box and block test

Description

measure of manual ability

Time Frame

Before (baseline) and 30 minutes (post-treatment) after each of the two sessions (sham or real SWT)

Title

Fugl Meyer Assessment - computerized adaptive testing

Description

neurological impairment

Time Frame

Before (baseline) and 25 minutes (post-treatment) after each of the two sessions (sham or real SWT)

Title

Abilhand scale

Description

PROMS on bimanual activities; a higher score represents a better manual ability

Time Frame

Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT)

Title

Wolff Motor Function Test

Description

manual activities

Time Frame

Before (baseline) and 35 minutes (post-treatment) after each of the two sessions (sham or real SWT)

Title

Visual Analog Scale

Description

patient self-assessment of overall effectiveness of SWT; score from 0 to 4 (a higher score representing a greater improvement)

Time Frame

Before (baseline) and 45 minutes (post-treatment) after each of the two sessions (sham or real SWT)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gaëtan Stoquart, MD PhD

Phone

+3227641650

gaetan.stoquart@uclouvain.be

First Name & Middle Initial & Last Name or Official Title & Degree

Clara Selves, MD

Phone

+3227641650

clara.selves@uclouvain.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gaëtan Stoquart, MD, PhD

Organizational Affiliation

Cliniques universitaires Saint-Luc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cliniques universitaires Saint-Luc

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gaëtan Stoquart, MD PhD

Phone

+327641650

gaetan.stoquart@uclouvain.be

First Name & Middle Initial & Last Name & Degree

Clara Selves, MD

Phone

+327641650

clara.selves@uclouvain.be

12. IPD Sharing Statement

Plan to Share IPD

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Effectiveness of Shock Wave Therapy for Upper Limb Spasticity

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