Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-28

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke Equinus Deformity Spasticity, Muscle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GROUP 1

1 session of fESWT

Group Type ACTIVE_COMPARATOR

fESWT

Intervention Type DEVICE

Shock wave therapy will be applied with Duolith SD1 device (Storz Medical, Tagerwilen, Switzerland). Therapy will be administered in the gastrocnemius medial and lateral and in the soleus muscles.

Parameters: 0.15mJ/mm2, 4-5 Hz, 1500 shoots/muscle.

GROUP 2

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

Group Type EXPERIMENTAL

fESWT

Intervention Type DEVICE

Shock wave therapy will be applied with Duolith SD1 device (Storz Medical, Tagerwilen, Switzerland). Therapy will be administered in the gastrocnemius medial and lateral and in the soleus muscles.

Parameters: 0.15mJ/mm2, 4-5 Hz, 1500 shoots/muscle.

Interventions

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fESWT

Shock wave therapy will be applied with Duolith SD1 device (Storz Medical, Tagerwilen, Switzerland). Therapy will be administered in the gastrocnemius medial and lateral and in the soleus muscles.

Parameters: 0.15mJ/mm2, 4-5 Hz, 1500 shoots/muscle.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No