Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06547684

Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities EQUINUS DEFORMITY Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasticity, Muscle Talipes Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Plana

Vila-real, Castellon, 12540, Spain

Location status: Recruiting

Location contact

Teresa Mª Mateu Campos

CONTACT

[email protected]

+34666803771

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fESWT

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.

Primary outcomes

  1. Modified Ashworth Scale (MAS)

    Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.

    A manual measurement of the resistance os muscles during passive stretching. Score from 0 to 4, higher scores mean a worse outcome

Secondary outcomes

  1. Passive Ankle range of motion (PROM)

    Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.

    Measure with goniometer

  2. Visual Analogue Scale (VAS) Pain Score

    Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.

    Pain Score: from 0 (no pain) to 10 (the worst imaginable pain)

  3. 10 Meters Walk Test

    Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.

    Measure the gait speed

  4. Test Up and Go (TUG)

    Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.

    Asses the mobility and balance

  5. Spasm Frequency Scale

    Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.

    Estimate muscle spams. Score 0 (no spams) to 4 (>10 spams)

  6. Test 6 Minutes Walking

    Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.

    Asses walking resistance

  7. Fall Skip Device

    Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.

    Assesment of fall risk

  8. Stroke Quality of Life Scale (ECVI-38)

    Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.

    A questionnaire of 38 items: from 1 (no problem) to 190 (the worst situation)

  9. Self Report Spasticity Scale (SRSS)

    Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.

    A questionnaire of 8 items: from 0 (nothing) to 24 (cpmpletely)

Study contacts

Contact information is provided by the study sponsor or research team.

Teresa Mª Mateu Campos

CONTACT

[email protected]

+34666803771

Sponsors and collaborators

Lead sponsor

Teresa Mateu Campos

Other

Registry information

Official study title

Effects of Focused Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients: a Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.