StrokeNCT06547684
Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients
A study testing fESWT in people with Stroke and Equinus Deformity, run by Teresa Mateu Campos at 1 site in Spain.
Trial summary
The goal of this study is to evaluate long term effects of focused extracorporeal shock wave therapy (fESWT) on triceps surae spasticity in stroke patients according to the number of sessions applied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Equinus Deformity, Spasticity, Muscle
- What is being tested?
- fESWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 28 Aug 2020to 31 Oct 2025
- 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
- Age greater than 18 years old
- Time from stroke (ischemic o hemorrhagic) onset of at least 6 months
- Spastic equinus foot: triceps surae tone grade at least 1+ on the MAS score
- Ability to walk alone with or without aids
Who cannot join
- Fixed ankle joint contracture
- Severe medical problems
- Treatment of the affected leg with botulinum toxin in the las 6 months
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Plana
Vila-real, Castellon, 12540
Teresa Mª Mateu Campos, +34666803771, teremateuc@gmail.com
About this study
Official title: Effects of Focused Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients: a Randomized Controlled Trial
The goal of this study is to evaluate long term effects of focused extracorporeal shock wave therapy (fESWT) on triceps surae spasticity in stroke patients according to the number of sessions applied.
Hypothesis: 3 sessions of fESWT on equinus foot in stroke patients improve spasticity and functionality for longer term than 1 session of fESWT.
Read the detailed description
Spasticity is a common complication as a consequence of suffering a stroke and one of the most important causes of disability in this pathology.
Global data estimate that 12 million people world-wide suffer from spasticity of the upper or lower limb. Equinus foot is the most common pattern of the lower extremities.
Previous studies have reported that extracorporeal shock wave therapy (ESWT) is a safe and noninvasive alternative treatment for spasticity.
Although the authors have shown a beneficial clinical effect of the ESWT, outcomes and duration of effect varied across studies.
This is a prospective randomized controlled trial. 60 stroke patients with spastic equinus foot post stroke will enroll in this study.
The participants will be randomly divided into two groups. The first group (control group) will receive 1 session of fESWT, while the second group (experimental group) will receive 3 sessions of fESWT, once a week, for 3 consecutive weeks.
Therapy will be administered directly to the muscle bellies of the gastrocnemius medial and lateral and soleus. The muscle belly will be located by ultrasonography.
The primary outcome is modified Ashworth scale. Secondary outcomes are passive range of ankle motion, mobility and balance test, spasm frequency scale and quality of life scales.
Participants will be evaluated by the same researcher before the first shock wave therapy and after the last session of fESWT will be done periodic revisions on weeks 1, 4, 8, 12, 20, 24, 36 and 48. Adverse events will be monitored during the study.
- Conditions
- Stroke, Equinus Deformity, Spasticity, Muscle
- Being tested
- fESWT
- Keywords
- Stroke, Equinus Deformity, Extracorporeal Shock Wave Therapy
- Medical subject headings
- Stroke, Equinus Deformity, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fESWTDevice
Shock wave therapy will be applied with Duolith SD1 device (Storz Medical, Tagerwilen, Switzerland). Therapy will be administered in the gastrocnemius medial and lateral and in the soleus muscles.
Parameters: 0.15mJ/mm2, 4-5 Hz, 1500 shoots/muscle.
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Active comparator | 1 session of fESWT Receives: Device: fESWT |
| GROUP 2 | Experimental | 3 sessions of fESWT (1 session per week for 3 consecutive weeks) Receives: Device: fESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale (MAS)
A manual measurement of the resistance os muscles during passive stretching. Score from 0 to 4, higher scores mean a worse outcome
Measured: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Secondary outcomes (9)
Passive Ankle range of motion (PROM)
Measure with goniometer
Measured: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Visual Analogue Scale (VAS) Pain Score
Pain Score: from 0 (no pain) to 10 (the worst imaginable pain)
Measured: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
10 Meters Walk Test
Measure the gait speed
Measured: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Test Up and Go (TUG)
Asses the mobility and balance
Measured: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Spasm Frequency Scale
Estimate muscle spams. Score 0 (no spams) to 4 (>10 spams)
Measured: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Test 6 Minutes Walking
Asses walking resistance
Measured: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Fall Skip Device
Assesment of fall risk
Measured: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Stroke Quality of Life Scale (ECVI-38)
A questionnaire of 38 items: from 1 (no problem) to 190 (the worst situation)
Measured: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Self Report Spasticity Scale (SRSS)
A questionnaire of 8 items: from 0 (nothing) to 24 (cpmpletely)
Measured: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start28 Aug 2020
- Primary completion7 Sep 2024
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teresa Mateu Campos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Teresa Mateu Campos, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Investigators
- Teresa Mª Mateu Campos, Principal investigator, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547684
- Sponsor's protocol ID
- TMC-OCF-2019-02
- Status last verified
- Sep 2024
- First submitted
- 7 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guo P, Gao F, Zhao T, Sun W, Wang B, Li Z. Positive Effects of Extracorporeal Shock Wave Therapy on Spasticity in Poststroke Patients: A Meta-Analysis. J Stroke Cerebrovasc Dis. 2017 Nov;26(11):2470-2476. doi: 10.1016/j.jstrokecerebrovasdis.2017.08.019. Epub 2017 Sep 13.
PubMed 28918085Lee JY, Kim SN, Lee IS, Jung H, Lee KS, Koh SE. Effects of Extracorporeal Shock Wave Therapy on Spasticity in Patients after Brain Injury: A Meta-analysis. J Phys Ther Sci. 2014 Oct;26(10):1641-7. doi: 10.1589/jpts.26.1641. Epub 2014 Oct 28.
PubMed 25364134Taheri P, Vahdatpour B, Mellat M, Ashtari F, Akbari M. Effect of Extracorporeal Shock Wave Therapy on Lower Limb Spasticity in Stroke Patients. Arch Iran Med. 2017 Jun;20(6):338-343.
PubMed 28646841
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Focused Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06547684
- Acronym / sponsor ID
- TMC-OCF-2019-02
- Conditions
- Stroke, Equinus Deformity, Spasticity, Muscle
- Keywords
- Stroke, Equinus Deformity, Extracorporeal Shock Wave Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Teresa Mateu CamposUniversity, hospital or other
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 7 Sep 2024 (actual)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 9 Aug 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.
The goal of this study is to evaluate long term effects of focused extracorporeal shock wave therapy (fESWT) on triceps surae spasticity in stroke patients according to the number of sessions applied.
Hypothesis: 3 sessions of fESWT on equinus foot in stroke patients improve spasticity and functionality for longer term than 1 session of fESWT.
Detailed description
Spasticity is a common complication as a consequence of suffering a stroke and one of the most important causes of disability in this pathology.
Global data estimate that 12 million people world-wide suffer from spasticity of the upper or lower limb. Equinus foot is the most common pattern of the lower extremities.
Previous studies have reported that extracorporeal shock wave therapy (ESWT) is a safe and noninvasive alternative treatment for spasticity.
Although the authors have shown a beneficial clinical effect of the ESWT, outcomes and duration of effect varied across studies.
This is a prospective randomized controlled trial. 60 stroke patients with spastic equinus foot post stroke will enroll in this study.
The participants will be randomly divided into two groups. The first group (control group) will receive 1 session of fESWT, while the second group (experimental group) will receive 3 sessions of fESWT, once a week, for 3 consecutive weeks.
Therapy will be administered directly to the muscle bellies of the gastrocnemius medial and lateral and soleus. The muscle belly will be located by ultrasonography.
The primary outcome is modified Ashworth scale. Secondary outcomes are passive range of ankle motion, mobility and balance test, spasm frequency scale and quality of life scales.
Participants will be evaluated by the same researcher before the first shock wave therapy and after the last session of fESWT will be done periodic revisions on weeks 1, 4, 8, 12, 20, 24, 36 and 48. Adverse events will be monitored during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | Active comparator | Device: fESWT1 session of fESWT |
| GROUP 2 | Experimental | Device: fESWT3 sessions of fESWT (1 session per week for 3 consecutive weeks) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age greater than 18 years old
- Time from stroke (ischemic o hemorrhagic) onset of at least 6 months
- Spastic equinus foot: triceps surae tone grade at least 1+ on the MAS score
- Ability to walk alone with or without aids
Key exclusion criteria (4 listed)
- Fixed ankle joint contracture
- Severe medical problems
- Treatment of the affected leg with botulinum toxin in the las 6 months
- Cognitive impairment
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 |
|---|---|---|
| fESWTShock wave therapy will be applied with Duolith SD1 device (Storz Medical, Tagerwilen, Switzerland). Therapy will be administered in the gastrocnemius medial and lateral and in the soleus muscles. Parameters: 0.15mJ/mm2, 4-5 Hz, 1500 shoots/muscle. | Device | GROUP 1, GROUP 2 |
Primary outcome
Modified Ashworth Scale (MAS)
Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
A manual measurement of the resistance os muscles during passive stretching. Score from 0 to 4, higher scores mean a worse outcome
9 secondary outcomes
Passive Ankle range of motion (PROM)
Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Visual Analogue Scale (VAS) Pain Score
Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
10 Meters Walk Test
Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Test Up and Go (TUG)
Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Spasm Frequency Scale
Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Test 6 Minutes Walking
Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Fall Skip Device
Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Stroke Quality of Life Scale (ECVI-38)
Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Self Report Spasticity Scale (SRSS)
Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 28918085Guo P, Gao F, Zhao T, Sun W, Wang B, Li Z. Positive Effects of Extracorporeal Shock Wave Therapy on Spasticity in Poststroke Patients: A Meta-Analysis. J Stroke Cerebrovasc Dis. 2017 Nov;26(11):2470-2476. doi: 10.1016/j.jstrokecerebrovasdis.2017.08.019. Epub 2017 Sep 13.
- Background: PubMed 25364134Lee JY, Kim SN, Lee IS, Jung H, Lee KS, Koh SE. Effects of Extracorporeal Shock Wave Therapy on Spasticity in Patients after Brain Injury: A Meta-analysis. J Phys Ther Sci. 2014 Oct;26(10):1641-7. doi: 10.1589/jpts.26.1641. Epub 2014 Oct 28.
- Background: PubMed 28646841Taheri P, Vahdatpour B, Mellat M, Ashtari F, Akbari M. Effect of Extracorporeal Shock Wave Therapy on Lower Limb Spasticity in Stroke Patients. Arch Iran Med. 2017 Jun;20(6):338-343.
- Individual participant dataSharing planned: No
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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.
Teresa Mª Mateu Campos principal investigator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fESWT in people with Stroke and Equinus Deformity, run by Teresa Mateu Campos at 1 site in Spain.
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 4 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Teresa Mª Mateu Campos (+34666803771, teremateuc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (MAS) (time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.). 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 NCT06547684, which also lists 3 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 19 Sep 2024.