An interventional study of focused extracorporeal shock wave therapy (ESWT) and focused extracorporeal shock wave therapy (ESWT) in Stroke and Muscle Spasticity, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
Participants in this arm will receive focused Extracorporeal Shock Wave Therapy (ESWT) targeting four specific muscles: subscapularis, pectoralis major, latissimus dorsi, and teres major muscles. Each muscle will receive 1,000 shockwave shots per session, accumulating to a total of 4,000 shots across all targeted muscles in each session. The treatment will be administered twice a week for two consecutive weeks, resulting in a total of four treatment sessions.
Device: focused extracorporeal shock wave therapy (ESWT)
Participants in this arm will receive placebo-controlled focused ESWT, mirroring the treatment protocol of the experimental group but without the application of active shockwaves.
Device: focused extracorporeal shock wave therapy (ESWT)
The focused shockwaves are directed at the affected muscles in the upper limb, specifically targeting the subscapularis, pectoralis major, latissimus dorsi, and teres major muscles.
Placebo shockwave therapy directed at subscapularis, pectoralis major, latissimus dorsi, and teres major muscles.
passive range of motion for the shoulder joints
the extent to which a joint can be moved without the patient actively participating in the movement
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
shoulder strength
the muscle power generated by the shoulder muscles, quantified using the Medical Research Council (MRC) scale, which grades muscle strength from 0 (no visible contraction) to 5 (normal strength against full resistance)
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Visual Analogue Scale (VAS)
individuals rate their pain from 0 to 10, where 0 represents 'no pain' and 10 signifies 'the worst pain imaginable
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
modified Ashworth scale (MAS)
Evaluate spasticity in individuals with neurological conditions. The scale ranges from 0, indicating no increase in muscle tone, to 4, which represents severe spasticity with affected parts rigid in flexion or extension.
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Fugl-Meyer Assessment for the Upper Extremity (FMA-UE)
range from 0 (complete paralysis) to 66 (full function), assessing motor recovery in post-stroke upper extremities
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Action Research Arm Test (ARAT)
a standardized measure evaluating upper limb motor ability in stroke patients, scoring from 0 (no movement) to 57 (normal arm function). It assesses grasp, grip, pinch, and gross arm movement.
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Barthel index
measures a person's daily living abilities, focusing on ten areas of self-care and mobility. Scores range from 0 to 100, with higher scores denoting greater independence.
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
Wolf Motor Function Test
assess upper extremity function in individuals with neurological impairments, using 17 tasks divided into sections of time, functional ability, and strength. Scoring is on a 6-point ordinal scale, ranging from 0 ("Does not attempt with upper extremity being tested," indicating severe impairment) to 5 ("Movement appears to be normal," suggesting full functionality). Lower scores indicate greater impairment.
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
ultrasound assessment
used strain elastography to assess elasticity of shoulder muscles
Time frame: pre-treatment; 1, 4, 12, and 24 weeks post-treatment
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