Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06365476

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

Led by National Taiwan University Hospital · Updated on 2025-07-29

40

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are exploring the use of focused Extracorporeal Shock Wave Therapy (ESWT) to treat upper limb spasticity in patients who have experienced a stroke. This study evaluates the therapy's effects specifically on the wrist and finger flexor muscles, aiming to improve muscle tone and function. The trial is a randomized, controlled investigation sponsored by National Taiwan University Hospital, targeting adults with post-stroke spasticity. Participants are randomly assigned to one of two groups. One group receives focused ESWT targeting three forearm muscles: flexor carpi ulnaris, flexor carpi radialis, and flexor digitorum superficialis. Each muscle is treated with 1,500 shockwave pulses per session, with sessions conducted twice a week for two weeks, totaling four treatments. The control group undergoes a placebo procedure mimicking the therapy without active shockwaves. Throughout the study, participants undergo assessments before treatment and at 1, 4, 12, and 24 weeks after therapy. These evaluations include measures of wrist and finger joint movement, hand grip strength, pain levels, muscle spasticity using established scales, functional ability, and daily living activities. Additional tests involve ultrasound and electromyography to observe muscle changes. The study monitors both immediate and lasting effects of the therapy on upper limb function and spasticity.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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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)

Treatment

Duration - 2 weeks

Participants receive focused Extracorporeal Shock Wave Therapy (ESWT) or placebo treatments targeting specific forearm muscles, administered twice weekly for two weeks.

4 treatment sessions (in-person)

Follow-up

Duration - 24 weeks

Participants are assessed at multiple time points after treatment to evaluate upper limb function and spasticity.

5 follow-up visits at 1, 4, 12, and 24 weeks post-treatment

Trial Site Locations

Total: 1 location

1

Department of Physical Medicine & Rehabilitation , National Taiwan University Hospital

Taipei, Taipei, Taiwan, 100

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Research Team

S

Shu-mei Yang, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Extracorporeal Shock Wave Stimulation as Alternative Treatment Modality for Wrist and Fingers Spasticity in Poststroke Patients: A Prospective, Open-Label, Preliminary Clinical Trial.

Robert Dymarek, Jakub Taradaj, Joanna Rosińczuk

https://pubmed.ncbi.nlm.nih.gov/27504139

The effectiveness of extracorporeal shock wave therapy to reduce lower limb spasticity in stroke patients: a systematic review and meta-analysis.

Rosa Cabanas-Valdés, Jordi Calvo-Sanz, Gerard Urrùtia...

https://pubmed.ncbi.nlm.nih.gov/31710277

Long-term Effects of Extracorporeal Shock Wave Therapy on Poststroke Spasticity: A Meta-analysis of Randomized Controlled Trials.

Gongwei Jia, Jingxi Ma, Sanrong Wang...

https://pubmed.ncbi.nlm.nih.gov/31899073