SIRS-ESWT Trial: Shoulder Internal Rotator Spasticity Trial Treated With Extracorporeal Shock Wave Therapy Trial

Last updated: November 3, 2024
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Limb Spasticity

Treatment

focused extracorporeal shock wave therapy (ESWT)

Clinical Study ID

NCT06674785
202409035RIND
  • Ages > 18
  • All Genders

Study Summary

Extracorporeal shock wave therapy (ESWT) has shown potential in reducing post-stroke limb spasticity. This study aims to evaluate the efficacy of focused ESWT on shoulder internal rotator spasticity in post-stroke patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged 18 years or older with unilateral cerebral stroke.

  • Restricted passive external rotation of the spastic shoulder by more than 20degrees.

  • A Modified Ashworth Scale score of 1 or higher for shoulder internal rotatorspasticity.

  • Stable medical condition and vital signs.

  • Clear consciousness, able to follow instructions.

Exclusion

Exclusion Criteria:

  • History of two or more strokes, traumatic brain injury, brain tumors, or othercerebral disorders.

  • Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson'sdisease) or other musculoskeletal conditions affecting muscle tone assessment.

  • Ineligibility for shock wave intervention due to malignancies, coagulationdisorders, localized infections, or presence of a pacemaker.

  • Prior shock wave intervention or botulinum toxin injection for post-strokespasticity within the past three months.

  • Inability to participate in interventions or functional assessments due tocognitive, consciousness, or language impairments.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: focused extracorporeal shock wave therapy (ESWT)
Phase:
Study Start date:
January 01, 2025
Estimated Completion Date:
December 31, 2027

Study Description

This study aimed to evaluate the effects of focused extracorporeal shock wave therapy (ESWT) on shoulder internal rotator spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific shoulder internal rotators, and a control group receiving placebo treatments mimicking the shockwave therapy, with treatments administered twice weekly over two weeks for a total of four sessions.

The efficacy of the treatment was measured using a comprehensive set of assessment tools, including range of motion, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, and ultrasound strain elastography. The outcomes were evaluated at multiple points in time: before treatment, and 1, 4, 12, and 24 weeks after the therapy concluded, to assess both immediate and sustained effects of the treatment on shoulder function and spasticity in stroke survivors.

Connect with a study center

  • Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital

    Taipei,
    Taiwan

    Active - Recruiting

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