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 | Active Not Recruiting

• 1 other identifier: 24/132-EC_P
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Botulinum Toxin A; Extracorporeal Shock Wave Therapy; Equinovarus Foot; Spasticity; ESWT; Stroke

Outcome Measures

Primary Outcomes (1)

• Change in spasticity assessed by the Modified Ashworth Scale (MAS)

  Change in lower-limb spasticity measured using the Modified Ashworth Scale (MAS) after treatment.

  Baseline, 4, 12, 24, 28, 42 and 54 weeks.

Secondary Outcomes (7)

• Modified Tardieu Scale

  Baseline, 4, 12, 24, 28, 42 and 54 weeks

• Change in passive ankle dorsiflexion range of motion

  Baseline, 4, 12, 24, 28, 42 and 54 weeks

• Change in lower-limb muscle strength assessed by the Medical Research Council Scale

  Baseline, 4, 12, 24, 28, 42 and 54 weeks

• Change in gait speed assessed by the 10-Meter Walk Test

  Baseline, 4, 12, 24, 28, 42 and 54 weeks

• Change in muscle echogenicity assessed by the Heckmatt Scale

  Baseline, 4, 12, 24, 28, 42 and 54 weeks

Study Arms (3)

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.

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.

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.

Drug: Botulinum toxin type A; Device: Focal Extracorporeal Shock Wave Therapy (ESWT)

Interventions

Botulinum toxin type A DRUG

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.

Also known as: OnabotulinumtoxinA

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) 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.

Focal ESWT After Botulinum Toxin Type A; Focal ESWT Before Botulinum Toxin Type A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• María Belén Martínez Luna: lead

Study Sites (1)

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Belén Martínez Luna, MD

  Hospital Clinico San carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to treatment allocation throughout the study. Participants will be instructed not to disclose their assigned intervention during follow-up assessments. The healthcare provider administering the interventions and the participants will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant in Physical Medicine and Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start: October 10, 2024
• Primary Completion (Estimated): October 8, 2026
• Study Completion (Estimated): October 8, 2026
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)