StrokeWaves2021NCT05255549
Feasibility of ESWT Treatment in Post-stroke Patients With Triceps Sural Spasticity
A study testing ESWT + Stretching in people with Stroke, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
The main objective is to evaluate the feasibility of two different rehabilitation protocols that differed from the number of treatment sessions (1 session of ESWT versus 3 weekly sessions of ESWT), in patients with triceps surae spasticity after stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- ESWT + Stretching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 22 Jul 2021to 22 Jul 2022
- Phase
- Interventional
- 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
Who may be able to join
- Adult patients of legal age
- Time elapsed since the stroke between 6 and 60 months
- Autonomous or supervised walking with or without aids
- Spasticity of the sural triceps> 1 on the MAS scale
Who cannot join
- Joint stiffness of the lower limbs due to other pathologies (ex orthopedic or rheumatological);
- Conditions that interfere with evaluation or collaboration in rehabilitation treatment (major psychiatric illnesses, clearly detectable cognitive deficits, severe pre-existing disabilities, sensory disturbances, etc.)
- Focal antispasmodic toxin treatments in the previous 3 months or phenolic blocks in the previous 9 months in the treatment region
- Treatments with central antispasmodic drugs with dosage modifications in the last week of starting treatment
- Individual neurorehabilitation treatments in progress
Trial locations and contacts
1 site in 1 country.
Italy1 site
Operational Unit of Physical Medicine and Rehabilitation AUSL - IRCCS Reggio Emilia
Reggio Emilia, Emilia-Romagna, 42123
About this study
Official title: ESWT Treatment in Post-stroke Patients With Triceps Sural: a Feasibility RCT
The main objective is to evaluate the feasibility of two different rehabilitation protocols that differed from the number of treatment sessions (1 session of ESWT versus 3 weekly sessions of ESWT), in patients with triceps surae spasticity after stroke. In both arms the other ESWT parameters (types of ESWT, intensity, frequency, location) and stretching sessions are the same.
Secondary objectives: to compare functional performances in these two groups of patients receiving the different rehabilitation protocol with ESWT, using the following parameters:
- Six Minutes walking test (6MWT) ; - Time Up \& Go (TUG); - Modified Ashworth scale (MAS); - Lower Extremity Functional Scale (LEFS); - passive ankle range of motion (p-ROM), pain (NRS); and presence of ankle clonus. These parameters are assessed during baseline (T0), after 4 weeks (T1) and after 12 weeks (T2).
- Conditions
- Stroke
- Being tested
- ESWT + Stretching, ESWT and SHAM + Stretching
- Keywords
- Stroke, Triceps Sural Spasticity, Extracorporeal Shockwave Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWT + StretchingProcedure or surgery
3 weeks intervention:
- 3 sessions of ESWT, once a week
- 6 sessions of passive stretching, twice a week
ESWT and SHAM + StretchingProcedure or surgery
3 weeks intervention:
- 1 sessions of ESWT + 2 sessions of Sham, once a week
- 6 sessions of passive stretching, twice a week
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Not described Receives: Procedure: ESWT + Stretching |
| Group II | Sham comparator | Not described Receives: Procedure: ESWT and SHAM + Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of two kind treatments proposed
The intervention is feasible if at least 80% of the enrolled patients complete the entire treatment foreseen in the allocation group
Measured: T1 after 4 weeks from T0 (Enrollment)
Secondary outcomes (7)
Change in Walking Resistance
6 minute walking test
Measured: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in Level of mobility and balance
Timed Up \& Go Test
Measured: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in spasticity
Modified Ashworth Scale (MAS). Score from 0 to 4, higher scores mean a worse outcome
Measured: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in Passive ROM of the ankle in dorsiflexion
Passive ankle Range of Motion (p-ROM)
Measured: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in Leg Pain
Numeric Pain Rating Scale (NPRS) Score from 0 to 10, higher scores mean a worse outcome
Measured: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in Ability to carry out activities of daily living
Lower Extremity Functional Scale (LEFS). Score from 0 to 80, higher scores mean a better outcome.
Measured: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in triceps clones
Presence of ankle clonus
Measured: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start22 Jul 2021
- Primary completion22 Jul 2022
- Study completion22 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Stefania Testoni, Dr, Principal investigator, Azienda AUSLRE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255549
- Sponsor's protocol ID
- 31032021
- Acronym
- Waves2021
- Status last verified
- Nov 2021
- First submitted
- 5 Feb 2022
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESWT Treatment in Post-stroke Patients With Triceps Sural: a Feasibility RCT
- ClinicalTrials.gov ID
- NCT05255549
- Acronym / sponsor ID
- Waves2021 / 31032021
- Conditions
- Stroke
- Keywords
- Stroke, Triceps Sural Spasticity, Extracorporeal Shockwave Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 22 Jul 2021 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 22 Jul 2022 (actual)
- First posted
- 24 Feb 2022 (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.
The main objective is to evaluate the feasibility of two different rehabilitation protocols that differed from the number of treatment sessions (1 session of ESWT versus 3 weekly sessions of ESWT), in patients with triceps surae spasticity after stroke. In both arms the other ESWT parameters (types of ESWT, intensity, frequency, location) and stretching sessions are the same.
Secondary objectives: to compare functional performances in these two groups of patients receiving the different rehabilitation protocol with ESWT, using the following parameters:
- Six Minutes walking test (6MWT) ; - Time Up \& Go (TUG); - Modified Ashworth scale (MAS); - Lower Extremity Functional Scale (LEFS); - passive ankle range of motion (p-ROM), pain (NRS); and presence of ankle clonus. These parameters are assessed during baseline (T0), after 4 weeks (T1) and after 12 weeks (T2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Procedure: ESWT + Stretching |
| Group II | Sham comparator | Procedure: ESWT and SHAM + Stretching |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients of legal age
- Time elapsed since the stroke between 6 and 60 months
- Autonomous or supervised walking with or without aids
- Spasticity of the sural triceps> 1 on the MAS scale
Key exclusion criteria (5 listed)
- Joint stiffness of the lower limbs due to other pathologies (ex orthopedic or rheumatological);
- Conditions that interfere with evaluation or collaboration in rehabilitation treatment (major psychiatric illnesses, clearly detectable cognitive deficits, severe pre-existing disabilities, sensory disturbances, etc.)
- Focal antispasmodic toxin treatments in the previous 3 months or phenolic blocks in the previous 9 months in the treatment region
- Treatments with central antispasmodic drugs with dosage modifications in the last week of starting treatment
- Individual neurorehabilitation treatments in progress
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 |
|---|---|---|
| ESWT + Stretching3 weeks intervention: * 3 sessions of ESWT, once a week * 6 sessions of passive stretching, twice a week | Procedure or surgery | Group I |
| ESWT and SHAM + Stretching3 weeks intervention: * 1 sessions of ESWT + 2 sessions of Sham, once a week * 6 sessions of passive stretching, twice a week | Procedure or surgery | Group II |
Primary outcome
Feasibility of two kind treatments proposed
Time frame: T1 after 4 weeks from T0 (Enrollment)
The intervention is feasible if at least 80% of the enrolled patients complete the entire treatment foreseen in the allocation group
7 secondary outcomes
Change in Walking Resistance
Time frame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in Level of mobility and balance
Time frame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in spasticity
Time frame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in Passive ROM of the ankle in dorsiflexion
Time frame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in Leg Pain
Time frame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in Ability to carry out activities of daily living
Time frame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
Change in triceps clones
Time frame: T0 Enrollment, T1 after 4 weeks from T0, T2 after 12 weeks from T0
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 24 Jun 2025.
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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.
Stefania Testoni, Dr principal investigator
Azienda AUSLRE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWT + Stretching in people with Stroke, run by Azienda USL Reggio Emilia - IRCCS 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 4 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 24 Jun 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. Some participants in this study may receive a placebo. 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?
Feasibility of two kind treatments proposed (time frame: T1 after 4 weeks from T0 (Enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2025.