StrokeSASHANCT06311526
Mechanism of Action of Focal Extracorporeal Shock Waves as a Treatment of Upper Limb Stroke Spasticity: a Pilot Study
An observational study of Stroke and Hemiparesis, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiparesis, Hemiplegia
- What is being tested?
- Extracorporeal Shockwave Therapy
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- 30 May 2023to 13 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients with an upper limb spastic paresis.
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- Extracorporeal Shockwave Therapy
- Keywords
- Spasticity, Stroke, Extracorporeal Shockwave Therapy, Stroke upper limb impairment, Neurophysiology, Musculoskeletal ultrasound
- Medical subject headings
- Stroke, Paresis, Hemiplegia, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave TherapyOther
Extracorporeal Shockwave Therapy administered to the belly of spastic muscles of the upper limb.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients suffering a spastic upper limb paresis | Not described Receives: Other: Extracorporeal Shockwave Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
M wave and H reflex recruitment curve
Recruitment curves of the Flexor Carpi Radialis muscle of both upper limbs
Measured: 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
Post-activation depression of the Flexor Carpi Radialis H reflex of both sides
Measured: At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention
F waves
F waves of the First Dorsal Interosseus muscles of both upper limbs
Measured: At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention
T reflex
T reflex of the Flexor Carpi Radialis of both sides
Measured: At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention
Secondary outcomes (2)
Upper limb dexterity measures
Functional Assessment Test for Upper Limb
Measured: 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
Echographic assessment of the arm and forearm muscles
Measured: At baseline, after 7, 14 and 21 days of intervention, at 28 and 84 days after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start30 May 2023
- Primary completion13 Mar 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311526
- Sponsor's protocol ID
- 24C303
- Acronym
- SASHA
- Status last verified
- Nov 2025
- First submitted
- 8 Mar 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The database will be made available upon request on Zenodo.
Publications
Wissel J, Manack A, Brainin M. Toward an epidemiology of poststroke spasticity. Neurology. 2013 Jan 15;80(3 Suppl 2):S13-9. doi: 10.1212/WNL.0b013e3182762448.
PubMed 23319481Manganotti P, Amelio E. Long-term effect of shock wave therapy on upper limb hypertonia in patients affected by stroke. Stroke. 2005 Sep;36(9):1967-71. doi: 10.1161/01.STR.0000177880.06663.5c. Epub 2005 Aug 18.
PubMed 16109905Opara J, Taradaj J, Walewicz K, Rosinczuk J, Dymarek R. The Current State of Knowledge on the Clinical and Methodological Aspects of Extracorporeal Shock Waves Therapy in the Management of Post-Stroke Spasticity-Overview of 20 Years of Experiences. J Clin Med. 2021 Jan 12;10(2):261. doi: 10.3390/jcm10020261.
PubMed 33445623Pierrot-Deseilligny, E. & Burke, D. Contribution of Spinal Pathways to the Pathophysiology of Movement Disorders. The Circuitry of the Human Spinal Cord 565-579 (2012) doi:10.1017/CBO9781139026727.015.
Kohn AF, Floeter MK, Hallett M. Presynaptic inhibition compared with homosynaptic depression as an explanation for soleus H-reflex depression in humans. Exp Brain Res. 1997 Sep;116(2):375-80. doi: 10.1007/pl00005765.
PubMed 9348136Lundbye-Jensen J, Nielsen JB. Immobilization induces changes in presynaptic control of group Ia afferents in healthy humans. J Physiol. 2008 Sep 1;586(17):4121-35. doi: 10.1113/jphysiol.2008.156547. Epub 2008 Jul 3.
PubMed 18599534Lamy JC, Wargon I, Mazevet D, Ghanim Z, Pradat-Diehl P, Katz R. Impaired efficacy of spinal presynaptic mechanisms in spastic stroke patients. Brain. 2009 Mar;132(Pt 3):734-48. doi: 10.1093/brain/awn310. Epub 2008 Nov 26.
PubMed 19036767
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Action of Focal Extracorporeal Shock Waves as a Treatment of Upper Limb Stroke Spasticity: a Pilot Study
- ClinicalTrials.gov ID
- NCT06311526
- Acronym / sponsor ID
- SASHA / 24C303
- Keywords
- Spasticity, Stroke, Extracorporeal Shockwave Therapy, Stroke upper limb impairment, Neurophysiology, Musculoskeletal ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients suffering a spastic upper limb paresis | – | Other: Extracorporeal Shockwave Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients with an upper limb spastic paresis.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shockwave TherapyExtracorporeal Shockwave Therapy administered to the belly of spastic muscles of the upper limb. | Other | Stroke patients suffering a spastic upper limb paresis |
Primary outcome
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
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
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
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Background: PubMed 23319481Wissel J, Manack A, Brainin M. Toward an epidemiology of poststroke spasticity. Neurology. 2013 Jan 15;80(3 Suppl 2):S13-9. doi: 10.1212/WNL.0b013e3182762448.
- Background: PubMed 16109905Manganotti P, Amelio E. Long-term effect of shock wave therapy on upper limb hypertonia in patients affected by stroke. Stroke. 2005 Sep;36(9):1967-71. doi: 10.1161/01.STR.0000177880.06663.5c. Epub 2005 Aug 18.
- Background: PubMed 33445623Opara J, Taradaj J, Walewicz K, Rosinczuk J, Dymarek R. The Current State of Knowledge on the Clinical and Methodological Aspects of Extracorporeal Shock Waves Therapy in the Management of Post-Stroke Spasticity-Overview of 20 Years of Experiences. J Clin Med. 2021 Jan 12;10(2):261. doi: 10.3390/jcm10020261.
- BackgroundPierrot-Deseilligny, E. & Burke, D. Contribution of Spinal Pathways to the Pathophysiology of Movement Disorders. The Circuitry of the Human Spinal Cord 565-579 (2012) doi:10.1017/CBO9781139026727.015.
- Background: PubMed 9348136Kohn AF, Floeter MK, Hallett M. Presynaptic inhibition compared with homosynaptic depression as an explanation for soleus H-reflex depression in humans. Exp Brain Res. 1997 Sep;116(2):375-80. doi: 10.1007/pl00005765.
- Background: PubMed 18599534Lundbye-Jensen J, Nielsen JB. Immobilization induces changes in presynaptic control of group Ia afferents in healthy humans. J Physiol. 2008 Sep 1;586(17):4121-35. doi: 10.1113/jphysiol.2008.156547. Epub 2008 Jul 3.
- Background: PubMed 19036767Lamy JC, Wargon I, Mazevet D, Ghanim Z, Pradat-Diehl P, Katz R. Impaired efficacy of spinal presynaptic mechanisms in spastic stroke patients. Brain. 2009 Mar;132(Pt 3):734-48. doi: 10.1093/brain/awn310. Epub 2008 Nov 26.
- Individual participant dataSharing planned: Undecided. The database will be made available upon request on Zenodo.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hemiparesis, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06311526, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.