Post-Stroke SpasticityNCT07758322
Efficacy of Focused Shock Wave Therapy Before and After Botulinum Toxin Injection in Patients With Post-Stroke Spastic Equinus/Equinovarus Foot: A Randomized Clinical Trial
A study testing Botulinum toxin type A and Focal Extracorporeal Shock Wave Therapy (ESWT) in people with Post-Stroke Spasticity and Spastic Equinovarus Foot, run by María Belén Martínez Luna at 1 site in Spain.
Trial summary
Spastic equinovarus foot is the most common lower limb motor impairment after stroke and has a significant impact on gait, mobility, and quality of life. Botulinum toxin type A (BoNT-A) is considered the first-line treatment for focal post-stroke spasticity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Stroke Spasticity, Spastic Equinovarus Foot
- What is being tested?
- Botulinum toxin type A and Focal Extracorporeal Shock Wave Therapy (ESWT)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteSpain
- Study dates
- 10 Oct 2024to 8 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged 18 to 87 years.
- Clinical diagnosis of chronic stroke.
- Presence of unilateral spastic equinovarus foot.
- Lower-limb spasticity requiring treatment with botulinum toxin type A.
- Ability to understand the study procedures and provide written informed consent.
Who cannot join
- Botulinum toxin type A injection in the affected lower limb within the previous 12 weeks.
- Previous extracorporeal shock wave therapy in the affected lower limb within the previous 12 weeks.
- Fixed ankle contracture preventing passive correction.
- Other neurological or musculoskeletal disorders affecting gait assessment.
- Pregnancy or breastfeeding.
- Contraindications to botulinum toxin type A or extracorporeal shock wave therapy.
- Severe cognitive impairment preventing participation or informed consent.
- Participation in another interventional clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Focused Shock Wave Therapy Before and After Botulinum Toxin Injection in Patients With Post-Stroke Spastic Equinus/Equinovarus Foot
Spastic equinovarus foot is the most common lower limb motor impairment after stroke and has a significant impact on gait, mobility, and quality of life. Botulinum toxin type A (BoNT-A) is considered the first-line treatment for focal post-stroke spasticity. Extracorporeal shock wave therapy (ESWT) has shown promising results as an adjunctive treatment; however, the optimal timing for its administration in combination with BoNT-A remains unknown.
This prospective, randomized, evaluator-blinded clinical trial aims to determine whether focal ESWT administered before or after BoNT-A injection is more effective than BoNT-A alone in patients with chronic post-stroke spastic equinovarus foot. Sixty-nine participants will be randomly allocated to one of three treatment groups: (1) BoNT-A alone; (2) one session of focal ESWT immediately before BoNT-A injection; or (3) one session of focal ESWT two weeks after BoNT-A injection. The primary outcome is spasticity measured with the Modified Ashworth Scale (MAS). Secondary outcomes include the Modified Tardieu Scale, passive ankle range of motion, muscle strength (MRC), 10-Meter Walk Test (10MWT), Functional Ambulation Classification (FAC), pain (VAS), Patient-Specific Assessment Scale (PSAS), muscle echogenicity using the Heckmatt scale, and muscle stiffness assessed by real-time elastography. Assessments will be performed at baseline and during follow-up through week 54.
Read the detailed description
Stroke is one of the leading causes of long-term disability worldwide. Lower limb spasticity develops in a substantial proportion of stroke survivors, with the spastic equinovarus foot representing the most common gait pattern impairment. This condition negatively affects walking ability, balance, activities of daily living, and quality of life.
Botulinum toxin type A (BoNT-A) is considered the standard treatment for focal post-stroke spasticity. Nevertheless, its clinical effect is temporary and additional therapeutic strategies are needed to optimize and prolong treatment benefits. Extracorporeal shock wave therapy (ESWT) is a non-invasive intervention that has demonstrated beneficial effects on muscle tone, muscle stiffness, pain, and functional recovery. Experimental and clinical evidence suggests that ESWT may enhance the effects of BoNT-A, although the optimal timing of ESWT administration has not yet been established.
This study is a prospective, randomized, single-blind, three-arm clinical trial conducted at the Department of Physical and Rehabilitation Medicine of Hospital Clínico San Carlos (Madrid, Spain). Participants with chronic post-stroke spastic equinovarus foot who meet the eligibility criteria will be randomly assigned to one of three treatment groups:
Group A: BoNT-A injection alone.
Group B: One session of focal ESWT immediately before BoNT-A injection.
Group C: BoNT-A injection followed by one session of focal ESWT two weeks later. PROYECTO TESIS.docx
The primary outcome is lower limb spasticity measured using the Modified Ashworth Scale (MAS). Secondary outcomes include the Modified Tardieu Scale, passive ankle dorsiflexion range of motion, muscle strength measured by the Medical Research Council (MRC) scale, gait performance assessed by the 10-Meter Walk Test (10MWT) and Functional Ambulation Classification (FAC), pain assessed by the Visual Analogue Scale (VAS), patient-reported function using the Patient-Specific Assessment Scale (PSAS), muscle echogenicity using the Heckmatt scale, and muscle stiffness evaluated by real-time elastography. PROYECTO TESIS.docx
Clinical and ultrasound evaluations will be performed at baseline and at 4, 12, 24, 28, 42, and 54 weeks after treatment. The findings are expected to clarify whether the timing of focal ESWT administration influences the effectiveness of BoNT-A in the treatment of post-stroke spastic equinovarus foot and may contribute to optimizing rehabilitation protocols.
- Conditions
- Post-Stroke Spasticity, Spastic Equinovarus Foot
- Being tested
- Botulinum toxin type A, Focal Extracorporeal Shock Wave Therapy (ESWT)
- Keywords
- Botulinum Toxin A, Extracorporeal Shock Wave Therapy, Equinovarus Foot, Spasticity, ESWT, Stroke
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called OnabotulinumtoxinA
Botulinum toxin type A (Botox®, onabotulinumtoxinA) injected under ultrasound guidance into the spastic lower-limb muscles according to each participant's clinical presentation and the study protocol. Injection sites and doses are individualized based on the pattern and severity of spasticity.
Focal Extracorporeal Shock Wave Therapy (ESWT)Device
One session of focal extracorporeal shock wave therapy (ESWT) applied to the spastic calf muscles according to the study protocol using standardized treatment parameters.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A alone | Active comparator | Participants assigned to the control group receive botulinum toxin type A (Botox®, onabotulinumtoxinA) alone, injected under ultrasound guidance into the spastic lower-limb muscles according to the study protocol. No extracorporeal shock wave therapy is administered. Receives: Drug: Botulinum toxin type A |
| Focal ESWT Before Botulinum Toxin Type A | Experimental | Participants receive one session of focal extracorporeal shock wave therapy immediately before botulinum toxin type A (Botox®, onabotulinumtoxinA) injection into the spastic lower-limb muscles. Receives: Drug: Botulinum toxin type A; Device: Focal Extracorporeal Shock Wave Therapy (ESWT) |
| Focal ESWT After Botulinum Toxin Type A | Experimental | Participants receive botulinum toxin type A (Botox®, onabotulinumtoxinA) injection into the spastic lower-limb muscles, followed by one session of focal extracorporeal shock wave therapy two weeks later. Receives: Drug: Botulinum toxin type A; Device: Focal Extracorporeal Shock Wave Therapy (ESWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spasticity assessed by the Modified Ashworth Scale (MAS)
Change in lower-limb spasticity measured using the Modified Ashworth Scale (MAS) after treatment.
Measured: Baseline, 4, 12, 24, 28, 42 and 54 weeks.
Secondary outcomes (7)
Modified Tardieu Scale
Change in lower-limb spasticity assessed using the Modified Tardieu Scale, including the quality of muscle reaction and the angle of muscle reaction at different stretching velocities.
Measured: Baseline, 4, 12, 24, 28, 42 and 54 weeks
Change in passive ankle dorsiflexion range of motion
Passive ankle dorsiflexion range of motion will be measured in degrees using a goniometer, with the knee flexed and extended. Higher values indicate greater ankle dorsiflexion.
Measured: Baseline, 4, 12, 24, 28, 42 and 54 weeks
Change in lower-limb muscle strength assessed by the Medical Research Council Scale
Muscle strength will be assessed using the Medical Research Council Scale, ranging from 0 to 5, where 0 indicates no visible muscle contraction and 5 indicates normal muscle strength.
Measured: Baseline, 4, 12, 24, 28, 42 and 54 weeks
Change in gait speed assessed by the 10-Meter Walk Test
Gait speed will be assessed using the 10-Meter Walk Test and expressed in meters per second. Higher gait speed indicates better walking performance.
Measured: Baseline, 4, 12, 24, 28, 42 and 54 weeks
Change in muscle echogenicity assessed by the Heckmatt Scale
Muscle echogenicity will be assessed by ultrasound using the Heckmatt Scale, ranging from grade I to grade IV. Higher grades indicate increased muscle echogenicity and greater structural muscle alteration.
Measured: Baseline, 4, 12, 24, 28, 42 and 54 weeks
Change in pain intensity assessed by the Visual Analogue Scale
Pain intensity associated with spasticity will be assessed using a Visual Analogue Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: Baseline, 4, 12, 24, 28, 42 and 54 weeks
Change in patient-reported function assessed by the Patient-Specific Assessment Scale
Patient-reported difficulty with activities affected by spastic equinovarus foot will be assessed using the Patient-Specific Assessment Scale. The evaluated activities include maintaining balance, walking quickly, climbing stairs, descending stairs, and putting on shoes.
Measured: Baseline, 4, 12, 24, 28, 42 and 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start10 Oct 2024
- Primary completion8 Oct 2026 (estimated)
- Study completion8 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Stroke SpasticityStudies 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
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: (1) botulinum toxin type A (BoNT-A) alone; (2) focal extracorporeal shock wave therapy (ESWT) immediately before BoNT-A injection; or (3) focal ESWT administered two weeks after BoNT-A injection. Participants will remain in their assigned group throughout the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- María Belén Martínez Luna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, María Belén Martínez Luna, Hospital San Carlos, Madrid
- Investigators
- Belén Martínez Luna, MD, Principal investigator, Hospital Clinico San carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758322
- Sponsor's protocol ID
- 24/132-EC_P
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study consent and ethics approval do not include public sharing of de-identified individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focused Shock Wave Therapy Before and After Botulinum Toxin Injection in Patients With Post-Stroke Spastic Equinus/Equinovarus Foot
- ClinicalTrials.gov ID
- NCT07758322
- Acronym / sponsor ID
- 24/132-EC_P
- Conditions
- Post-Stroke Spasticity, Spastic Equinovarus Foot
- Keywords
- Botulinum Toxin A, Extracorporeal Shock Wave Therapy, Equinovarus Foot, Spasticity, ESWT, Stroke
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 69 participants (actual)
- Lead sponsor
- María Belén Martínez LunaUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 8 Oct 2026 (estimated)
- Study completion
- 8 Oct 2026 (estimated)
- First posted
- 11 Aug 2026 (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.
Spastic equinovarus foot is the most common lower limb motor impairment after stroke and has a significant impact on gait, mobility, and quality of life. Botulinum toxin type A (BoNT-A) is considered the first-line treatment for focal post-stroke spasticity. Extracorporeal shock wave therapy (ESWT) has shown promising results as an adjunctive treatment; however, the optimal timing for its administration in combination with BoNT-A remains unknown.
This prospective, randomized, evaluator-blinded clinical trial aims to determine whether focal ESWT administered before or after BoNT-A injection is more effective than BoNT-A alone in patients with chronic post-stroke spastic equinovarus foot. Sixty-nine participants will be randomly allocated to one of three treatment groups: (1) BoNT-A alone; (2) one session of focal ESWT immediately before BoNT-A injection; or (3) one session of focal ESWT two weeks after BoNT-A injection. The primary outcome is spasticity measured with the Modified Ashworth Scale (MAS). Secondary outcomes include the Modified Tardieu Scale, passive ankle range of motion, muscle strength (MRC), 10-Meter Walk Test (10MWT), Functional Ambulation Classification (FAC), pain (VAS), Patient-Specific Assessment Scale (PSAS), muscle echogenicity using the Heckmatt scale, and muscle stiffness assessed by real-time elastography. Assessments will be performed at baseline and during follow-up through week 54.
Detailed description
Stroke is one of the leading causes of long-term disability worldwide. Lower limb spasticity develops in a substantial proportion of stroke survivors, with the spastic equinovarus foot representing the most common gait pattern impairment. This condition negatively affects walking ability, balance, activities of daily living, and quality of life.
Botulinum toxin type A (BoNT-A) is considered the standard treatment for focal post-stroke spasticity. Nevertheless, its clinical effect is temporary and additional therapeutic strategies are needed to optimize and prolong treatment benefits. Extracorporeal shock wave therapy (ESWT) is a non-invasive intervention that has demonstrated beneficial effects on muscle tone, muscle stiffness, pain, and functional recovery. Experimental and clinical evidence suggests that ESWT may enhance the effects of BoNT-A, although the optimal timing of ESWT administration has not yet been established.
This study is a prospective, randomized, single-blind, three-arm clinical trial conducted at the Department of Physical and Rehabilitation Medicine of Hospital Clínico San Carlos (Madrid, Spain). Participants with chronic post-stroke spastic equinovarus foot who meet the eligibility criteria will be randomly assigned to one of three treatment groups:
Group A: BoNT-A injection alone.
Group B: One session of focal ESWT immediately before BoNT-A injection.
Group C: BoNT-A injection followed by one session of focal ESWT two weeks later. PROYECTO TESIS.docx
The primary outcome is lower limb spasticity measured using the Modified Ashworth Scale (MAS). Secondary outcomes include the Modified Tardieu Scale, passive ankle dorsiflexion range of motion, muscle strength measured by the Medical Research Council (MRC) scale, gait performance assessed by the 10-Meter Walk Test (10MWT) and Functional Ambulation Classification (FAC), pain assessed by the Visual Analogue Scale (VAS), patient-reported function using the Patient-Specific Assessment Scale (PSAS), muscle echogenicity using the Heckmatt scale, and muscle stiffness evaluated by real-time elastography. PROYECTO TESIS.docx
Clinical and ultrasound evaluations will be performed at baseline and at 4, 12, 24, 28, 42, and 54 weeks after treatment. The findings are expected to clarify whether the timing of focal ESWT administration influences the effectiveness of BoNT-A in the treatment of post-stroke spastic equinovarus foot and may contribute to optimizing rehabilitation protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel groups: (1) botulinum toxin type A (BoNT-A) alone; (2) focal extracorporeal shock wave therapy (ESWT) immediately before BoNT-A injection; or (3) focal ESWT administered two weeks after BoNT-A injection. Participants will remain in their assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin type A alone | Active comparator | Drug: Botulinum toxin type AParticipants assigned to the control group receive botulinum toxin type A (Botox®, onabotulinumtoxinA) alone, injected under ultrasound guidance into the spastic lower-limb muscles according to the study protocol. No extracorporeal shock wave therapy is administered. |
| Focal ESWT Before Botulinum Toxin Type A | Experimental | Drug: Botulinum toxin type A, Device: Focal Extracorporeal Shock Wave Therapy (ESWT)Participants receive one session of focal extracorporeal shock wave therapy immediately before botulinum toxin type A (Botox®, onabotulinumtoxinA) injection into the spastic lower-limb muscles. |
| Focal ESWT After Botulinum Toxin Type A | Experimental | Drug: Botulinum toxin type A, Device: Focal Extracorporeal Shock Wave Therapy (ESWT)Participants receive botulinum toxin type A (Botox®, onabotulinumtoxinA) injection into the spastic lower-limb muscles, followed by one session of focal extracorporeal shock wave therapy two weeks later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 87 years.
- Clinical diagnosis of chronic stroke.
- Presence of unilateral spastic equinovarus foot.
- Lower-limb spasticity requiring treatment with botulinum toxin type A.
- Ability to understand the study procedures and provide written informed consent.
Key exclusion criteria (8 listed)
- Botulinum toxin type A injection in the affected lower limb within the previous 12 weeks.
- Previous extracorporeal shock wave therapy in the affected lower limb within the previous 12 weeks.
- Fixed ankle contracture preventing passive correction.
- Other neurological or musculoskeletal disorders affecting gait assessment.
- Pregnancy or breastfeeding.
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 |
|---|---|---|
| Botulinum toxin type AAlso: OnabotulinumtoxinABotulinum toxin type A (Botox®, onabotulinumtoxinA) injected under ultrasound guidance into the spastic lower-limb muscles according to each participant's clinical presentation and the study protocol. Injection sites and doses are individualized based on the pattern and severity of spasticity. | Drug | Botulinum toxin type A alone, Focal ESWT After Botulinum Toxin Type A, Focal ESWT Before Botulinum Toxin Type A |
| Focal Extracorporeal Shock Wave Therapy (ESWT)One session of focal extracorporeal shock wave therapy (ESWT) applied to the spastic calf muscles according to the study protocol using standardized treatment parameters. | Device | Focal ESWT After Botulinum Toxin Type A, Focal ESWT Before Botulinum Toxin Type A |
Primary outcome
Change in spasticity assessed by the Modified Ashworth Scale (MAS)
Time frame: Baseline, 4, 12, 24, 28, 42 and 54 weeks.
Change in lower-limb spasticity measured using the Modified Ashworth Scale (MAS) after treatment.
7 secondary outcomes
Modified Tardieu Scale
Time frame: Baseline, 4, 12, 24, 28, 42 and 54 weeks
Change in passive ankle dorsiflexion range of motion
Time frame: Baseline, 4, 12, 24, 28, 42 and 54 weeks
Change in lower-limb muscle strength assessed by the Medical Research Council Scale
Time frame: Baseline, 4, 12, 24, 28, 42 and 54 weeks
Change in gait speed assessed by the 10-Meter Walk Test
Time frame: Baseline, 4, 12, 24, 28, 42 and 54 weeks
Change in muscle echogenicity assessed by the Heckmatt Scale
Time frame: Baseline, 4, 12, 24, 28, 42 and 54 weeks
Change in pain intensity assessed by the Visual Analogue Scale
Time frame: Baseline, 4, 12, 24, 28, 42 and 54 weeks
Change in patient-reported function assessed by the Patient-Specific Assessment Scale
Time frame: Baseline, 4, 12, 24, 28, 42 and 54 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study consent and ethics approval do not include public sharing of de-identified individual participant data
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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.
Belén Martínez Luna, MD principal investigator
Hospital Clinico San carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin type A and Focal Extracorporeal Shock Wave Therapy (ESWT) in people with Post-Stroke Spasticity and Spastic Equinovarus Foot, run by María Belén Martínez Luna 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in spasticity assessed by the Modified Ashworth Scale (MAS) (time frame: Baseline, 4, 12, 24, 28, 42 and 54 weeks.). 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 11 Aug 2026.