Mechanism of Action of Focal Extracorporeal Shock Waves as a Treatment of Upper Limb Stroke Spasticity: a Pilot Study (SASHA)

March 8, 2024 updated by: Istituto Auxologico Italiano

Spasticity, common after a stroke, aggravates the patient's motor impairment causing pain and limitation in daily activities such as eating, dressing and walking.

There are different spasticity treatments, such as botulinum neurotoxin, in the first place. Among the emerging therapies is focal extracorporeal shock wave therapy, consisting of a sequence of sonic (mechanical) impulses with high peak pressure.

Systematic reviews highlighted that shock waves effectively improve lower and upper limb spasticity. Moreover, the shock waves therapeutic effect can last up to 12 weeks from the last treatment session.

When used to treat stroke spasticity, the shock waves' mechanism of action is poorly detailed.

On the one side, shock waves could change the physical properties of the muscular tissue (e.g. viscosity, rigidity).

On the other, the shock waves produce a robust mechanical stimulation that massively activates muscle and skin mechanoreceptors (e.g. muscle spindles). This activation would modulate, in turn, the spinal (and supra-spinal) circuits involved in spasticity.

To our knowledge, no study investigated the shock waves mechanism of action in stroke upper limb spasticity.

Research question: do shock waves exert their therapeutic effect on spasticity by changing the muscle's physical properties or by indirectly modulating the excitability of spinal circuits?

Specific aims: To investigate the mechanism of action of shock wave therapy as a treatment of upper limb spasticity after a stroke.

Two major hypotheses will be contrasted: shock waves reduce hypertonia 1) by changing the muscle's physical features or 2) by changing the motoneurons excitability and the excitability of the stretch reflex spinal circuits.

Shock wave therapy is expected to improve spasticity, thus improving the following clinical tests: the Modified Ashworth Scale (an ordinal score of spasticity) and the Functional Assessment for Upper Limb (FAST-UL, an ordinal score of upper limb dexterity).

This clinical improvement is expected to be associated with changes in spastic muscle echotexture assessed with ultrasounds, such as an improvement in the Heckmatt scale (an ordinal score of muscle echotexture in spasticity).

Clinical improvement is also expected to be associated with an improvement in the following neurophysiological parameters: a reduction of the H/Mmax ratio (an index of hyperexcitability of the monosynaptic stretch reflex circuit), a decrease in amplitude of the F waves (a neurophysiological signal reflecting the excitability of single/restricted motoneurones) and an increase of the homosynaptic depression (also known as post-activation depression, reflecting the excitability of the transmission between the Ia fibres and motoneurones).

Understanding the shock wave mechanism of action will lead to a better clinical application of this spasticity treatment.

If the shock waves exert their therapeutic effect by changing the muscle's physical properties, they could be more appropriate for patients with muscle fibrosis on ultrasounds.

On the contrary, if the shock waves work on spasticity by indirectly acting on the nervous system's excitability, then a neurophysiology study could be used to preliminary identify the muscle groups with the most significant neurophysiological alterations, which could be the muscles benefitting the most from this treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20122
        • Recruiting
        • IRCCS Istituto Auxologico Italiano
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Stroke patients with an upper limb spastic paresis.

Description

Inclusion criteria

  • age > 18 years
  • first hemispheric stroke at least six months ago
  • spasticity of wrist and elbow flexors muscles with grade 1 to 3 of the Modified Ashworth Scal
  • no botulinum toxin injection in the previous six months
  • ability to give informed consent

Exclusion criteria

  • anticoagulant medicine
  • presence of a pacemaker, an implantable cardioverter defibrillator or other medical devices
  • active cancer
  • skin lesions at the site of shock wave administration
  • an major neurological disease in addition to the hemiparesis (e.g. spastic hemiparesis in a patient who had Parkinson's disease before their stroke).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Stroke patients suffering a spastic upper limb paresis
Other: Extracorporeal Shockwave Therapy
Extracorporeal Shockwave Therapy administered to the belly of spastic muscles of the upper limb.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
M wave and H reflex recruitment curve
Time Frame: At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention
Recruitment curves of the Flexor Carpi Radialis muscle of both upper limbs
At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention
H reflex post-activation depression
Time Frame: At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention
Post-activation depression of the Flexor Carpi Radialis H reflex of both sides
At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention
F waves
Time Frame: At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention
F waves of the First Dorsal Interosseus muscles of both upper limbs
At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention
T reflex
Time Frame: At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention
T reflex of the Flexor Carpi Radialis of both sides
At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper limb dexterity measures
Time Frame: At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention
Functional Assessment Test for Upper Limb
At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention
Ultrasound arm and forearm assessment
Time Frame: At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention
Echographic assessment of the arm and forearm muscles
At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24C303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The database will be made available upon request on Zenodo.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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