Effectiveness of Shock Wave Therapy for Upper Limb Spasticity

NCT04316026 | Unknown

• 1 other identifier: 2019/27MAR/151
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (11)

• 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)

• objective measure of muscle stiffness

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

• manual goniometer

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

• Medical Research Council muscle testing

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

• Isokinetic dynamometer

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

Study Arms (2)

interventional group

EXPERIMENTAL

group receiving shock wave therapy

Device: shock wave therapy

control group

SHAM COMPARATOR

sham shock wave therapy

Device: shock wave therapy

Interventions

shock wave therapy DEVICE

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

control group; interventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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°

You may not qualify if:

• 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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gaëtan Stoquart, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaëtan Stoquart, MD PhD

CONTACT

+3227641650; gaetan.stoquart@uclouvain.be

Clara Selves, MD

CONTACT

+3227641650; clara.selves@uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: March 20, 2020
• Study Start: September 2, 2019
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)