MedTrace Logo

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

NCT07758322 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-08-11

No results posted yet for this study

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. 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.

Conditions

  • Post-Stroke Spasticity
  • Spastic Equinovarus Foot

Interventions

DRUG

Botulinum toxin type A

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.

DEVICE

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.

Sponsors & Collaborators

  • María Belén Martínez Luna

    lead OTHER

Principal Investigators

  • Belén Martínez Luna, MD · Hospital Clinico San carlos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-10
Primary Completion
2026-10-08
Completion
2026-10-08

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07758322 on ClinicalTrials.gov