Study of Focused Shock Wave Therapy to Treat Upper Limb Muscle Spasticity After Stroke
Led by National Taiwan University Hospital · Updated on 2025-07-29
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
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 therapys 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
Research Team
S
Shu-mei Yang, MD
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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
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
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
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.