Effectiveness of Shock Wave Therapy for Upper Limb Spasticity

NCT ID: NCT04316026

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-02
• Study Completion Date: 2024-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

interventional group

group receiving shock wave therapy

Group Type: EXPERIMENTAL

shock wave therapy

Intervention Type: 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

sham shock wave therapy

Group Type: SHAM_COMPARATOR

shock wave therapy

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaëtan Stoquart, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

Cliniques universitaires Saint-Luc

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Gaëtan Stoquart, MD PhD

Role: CONTACT

gaetan.stoquart@uclouvain.be

+3227641650

Clara Selves, MD

Role: CONTACT

clara.selves@uclouvain.be

+3227641650

Facility Contacts

Gaëtan Stoquart, MD PhD

Role: primary

gaetan.stoquart@uclouvain.be

+327641650

Clara Selves, MD

Role: backup

clara.selves@uclouvain.be

+327641650

Other Identifiers

2019/27MAR/151

Identifier Type: -

Identifier Source: org_study_id