Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06547684

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

Led by Teresa Mateu Campos · Updated on 2024-09-19

60

Participants Needed

1

Research Sites

59 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the long-term effects of focused extracorporeal shock wave therapy (fESWT) on muscle spasticity in stroke patients, specifically targeting the spastic equinus foot condition. This study compares whether three sessions of fESWT improve spasticity and functionality for a longer period than a single session. Spasticity is a common and disabling complication after stroke, affecting many globally, and this trial aims to clarify the best approach for treatment duration and effect. Participants will be randomly assigned to one of two groups: one receiving a single session of fESWT, and the other receiving three weekly sessions over three consecutive weeks. The therapy is delivered using a specialized device targeting muscle bellies of the gastrocnemius medial and lateral and soleus, located by ultrasound guidance. The study measures primary and secondary outcomes before treatment and at multiple follow-up points up to 48 weeks after the last session. During the study, participants will be assessed on muscle tone using the Modified Ashworth Scale and other functional and quality of life measures such as ankle motion range, mobility tests, spasm frequency, and stroke quality of life scales. Evaluations occur before treatment and at 1, 4, 8, 12, 20, 24, 36, and 48 weeks afterward. Researchers will monitor adverse events throughout the study, which involves 60 stroke patients with spastic equinus foot who can walk independently or with aids.

CONDITIONS

Brief Title

Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 18 years old
  • Time from stroke (ischemic or hemorrhagic) onset of at least 6 months
  • Spastic equinus foot with triceps surae tone grade at least 1+ on the Modified Ashworth Scale
  • Ability to walk alone with or without aids
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 1 to 3 weeks depending on group assignment

Participants receive focused extracorporeal shock wave therapy (fESWT) applied to the gastrocnemius medial, lateral, and soleus muscles. One group receives a single session, while the other group receives 3 weekly sessions over 3 consecutive weeks.

1 to 3 visits (in-person) depending on group assignment

Follow-up

Duration - Up to 48 weeks after the last therapy session

Participants are evaluated periodically after the last session of therapy to assess outcomes such as muscle spasticity, ankle motion, mobility, pain, spasm frequency, and quality of life. Adverse events are monitored throughout this period.

Visits at weeks 1, 4, 8, 12, 20, 24, 36, and 48 after the last session

Trial Site Locations

Total: 1 location

1

Hospital de la Plana

Vila-real, Castellon, Spain, 12540

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Research Team

T

Teresa Mª Mateu Campos

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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