Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients

Teresa Mateu Campos

Status: Enrolling

Conditions: Spasticity, Muscle; Equinus Deformity; Stroke

Treatments: Device: fESWT

Study type: Interventional

Funder types: Other

Identifiers

NCT06547684

TMC-OCF-2019-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Fixed ankle joint contracture
• Severe medical problems
• Treatment of the affected leg with botulinum toxin in the las 6 months
• Cognitive impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

GROUP 1

Active Comparator group

Description:

1 session of fESWT

Treatment:

Device: fESWT

GROUP 2

Experimental group

Description:

3 sessions of fESWT (1 session per week for 3 consecutive weeks)

Treatment:

Device: fESWT