NCT07758322Active, not recruiting
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
Focused Shock Wave Therapy Before and After Botulinum Toxin Injection in Patients With Post-Stroke Spastic Equinus/Equinovarus Foot
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 69 (actual)
- First submitted
- 6 Aug 2026
- Start date
- 10 Oct 2024
- Primary completion date
- 8 Oct 2026
- Lead sponsor
- María Belén Martínez Luna
- Diseases
- Stroke
- NCT number
- NCT07758322
What you commit to
- Study type: Interventional
- Participants enrolled: 69
- From 10 Oct 2024 to the primary completion date, 8 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Contraindications to botulinum toxin type A or extracorporeal shock wave therapy.
Other illness
- Other neurological or musculoskeletal disorders affecting gait assessment.
- Severe cognitive impairment preventing participation or informed consent.
Other
- Fixed ankle contracture preventing passive correction.
- Pregnancy or breastfeeding.
- Participation in another interventional clinical trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.