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Recruiting NCT06365476

FlexWave Trial: Efficacy of Extracorporeal Shock Wave Therapy in Post-Stroke Upper Limb Spasticity

No phase Interventional Stroke Spasticity, Muscle

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: focused extracorporeal shock wave therapy (ESWT).
Who it may be relevant to
Registry conditions: Stroke, Spasticity, Muscle. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of Extracorporeal Shock Wave for Upper Limb Flexor Spasticity in Stroke Patients: A Randomized Controlled Trial

Overview

Extracorporeal shock wave therapy (ESWT) has emerged as an effective therapeutic intervention for addressing post-stroke limb spasticity. This research aims to explore the therapeutic implications of focused ESWT for wrist and finger flexor muscles in patients suffering from post-stroke upper limb spasticity.

Detailed description

This study aimed to evaluate the effects of focused Extracorporeal Shock Wave Therapy (ESWT) on upper limb flexor spasticity in stroke patients. Participants were randomized into two groups: an experimental group receiving targeted ESWT on specific forearm flexor muscles, 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, hand grip strength, pain levels, spasticity scales, functional assessments, as well as measures of daily living activities, ultrasound strain elastography, and electromyography. 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 upper limb function and spasticity in stroke survivors.

Interventions

  • Device focused extracorporeal shock wave therapy (ESWT)
    The focused shockwaves are directed at the affected muscles in the upper limb, specifically targeting the flexor carpi ulnaris, flexor carpi radialis, and flexor digitorum superficialis.

Primary outcome measures

  • passive range of motion for the wrist and finger joints [Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
  • hand grip strength [Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
  • Visual Analogue Scale (VAS) [Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
  • modified Ashworth scale (MAS) [Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
  • modified Tardieu scale (MTS) [Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
Secondary outcome measures (7)
  • Fugl-Meyer Assessment for the Upper Extremity (FMA-UE) [Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
  • Action Research Arm Test (ARAT) [Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
  • Barthel index [Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
  • Functional Independence Measure (FIM) [Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
  • ultrasound assessment [Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
  • Box and Block Test [Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]
  • Wolf Motor Function Test [Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment]

Eligibility criteria

Inclusion criteria

  • Individuals aged 18 years or older with unilateral cerebral stroke.
  • Wrist and finger flexor muscle tone with a score greater than 1 on the Modified Ashworth Scale.
  • Stable medical condition and vital signs.
  • Conscious and able to comply with instructions.

Exclusion criteria

  • History of more than one stroke, traumatic brain injury, or cerebral neoplasm.
  • Coexisting central nervous system disorders (e.g., spinal cord injury, Parkinson's disease) or other musculoskeletal diseases affecting muscle tone assessment.
  • Contraindications for shockwave intervention, such as malignancies, coagulopathies, local infections, or use of cardiac pacemakers.
  • Undergone shockwave therapy or botulinum toxin injections for post-stroke spasticity in the past three months.
  • Cognitive, consciousness, or language impairments preventing participation in the intervention or functional assessments.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital — Taipei

Publications

  • Dymarek R, Taradaj J, Rosinczuk J. Extracorporeal Shock Wave Stimulation as Alternative Treatment Modality for Wrist and Fingers Spasticity in Poststroke Patients: A Prospective, Open-Label, Preliminary Clinical Trial. Evid Based Complement Alternat Med. 2016;2016:4648101. doi: 10.1155/2016/4648101. Epub 2016 Jul 18. PMID 27504139
  • Cabanas-Valdes R, Calvo-Sanz J, Urrutia G, Serra-Llobet P, Perez-Bellmunt A, German-Romero A. The effectiveness of extracorporeal shock wave therapy to reduce lower limb spasticity in stroke patients: a systematic review and meta-analysis. Top Stroke Rehabil. 2020 Mar;27(2):137-157. doi: 10.1080/10749357.2019.1654242. Epub 2019 Nov 11. PMID 31710277
  • Yasar E, Adiguzel E, Kesikburun S, Yenihayat I, Yilmaz B, Alaca R, Tan AK. Assessment of forearm muscle spasticity with sonoelastography in patients with stroke. Br J Radiol. 2016 Dec;89(1068):20160603. doi: 10.1259/bjr.20160603. Epub 2016 Oct 25. PMID 27679870
  • Jia G, Ma J, Wang S, Wu D, Tan B, Yin Y, Jia L, Cheng L. Long-term Effects of Extracorporeal Shock Wave Therapy on Poststroke Spasticity: A Meta-analysis of Randomized Controlled Trials. J Stroke Cerebrovasc Dis. 2020 Mar;29(3):104591. doi: 10.1016/j.jstrokecerebrovasdis.2019.104591. Epub 2019 Dec 31. PMID 31899073

Identifiers

NCT: NCT06365476 · 202309126RIND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗