Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients

NCT06547684 | Recruiting

• 1 other identifier: TMC-OCF-2019-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Equinus Deformity; Spasticity, Muscle

Keywords

Stroke; Equinus Deformity; Extracorporeal Shock Wave Therapy

Outcome Measures

Primary Outcomes (1)

• Modified Ashworth Scale (MAS)

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

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

Secondary Outcomes (9)

• Passive Ankle range of motion (PROM)

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

• Visual Analogue Scale (VAS) Pain Score

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

• 10 Meters Walk Test

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

• Test Up and Go (TUG)

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

• Spasm Frequency Scale

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

Study Arms (2)

GROUP 1

ACTIVE COMPARATOR

1 session of fESWT

Device: fESWT

GROUP 2

EXPERIMENTAL

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

Device: fESWT

Interventions

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.

GROUP 1; GROUP 2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Teresa Mateu Campos: lead

Study Sites (1)

Hospital de la Plana

Vila-real, Castellon, 12540, Spain

RECRUITING

Related Publications (3)

• Guo P, Gao F, Zhao T, Sun W, Wang B, Li Z. Positive Effects of Extracorporeal Shock Wave Therapy on Spasticity in Poststroke Patients: A Meta-Analysis. J Stroke Cerebrovasc Dis. 2017 Nov;26(11):2470-2476. doi: 10.1016/j.jstrokecerebrovasdis.2017.08.019. Epub 2017 Sep 13.

  PMID: 28918085 BACKGROUND

• Lee JY, Kim SN, Lee IS, Jung H, Lee KS, Koh SE. Effects of Extracorporeal Shock Wave Therapy on Spasticity in Patients after Brain Injury: A Meta-analysis. J Phys Ther Sci. 2014 Oct;26(10):1641-7. doi: 10.1589/jpts.26.1641. Epub 2014 Oct 28.

  PMID: 25364134 BACKGROUND

• Taheri P, Vahdatpour B, Mellat M, Ashtari F, Akbari M. Effect of Extracorporeal Shock Wave Therapy on Lower Limb Spasticity in Stroke Patients. Arch Iran Med. 2017 Jun;20(6):338-343.

  PMID: 28646841 BACKGROUND

MeSH Terms

Conditions

Stroke; Equinus Deformity; Muscle Spasticity

Condition Hierarchy (Ancestors)

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

Study Officials

• Teresa Mª Mateu Campos

  Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Mª Mateu Campos

CONTACT

+34666803771; teremateuc@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 9, 2024
• Study Start: August 28, 2020
• Primary Completion: September 7, 2024
• Study Completion: October 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)