Comparing different doses of shock wave therapy for ankle spasticity after stroke
The Dose Effectiveness of Extracorporeal Shockwave on Plantar Flexor Spasticity of Ankle in Stroke Patients: a Randomised Controlled Trial
NA · National Taiwan University Hospital Hsin-Chu Branch · NCT05878223
This study is testing whether different doses of shock wave therapy can help reduce ankle stiffness in people who have had a stroke.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Hsin-Chu Branch (other) |
| Locations | 1 site (Hsinchu) |
| Trial ID | NCT05878223 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) on ankle spasticity in chronic stroke patients. It will compare the effects of focused ESWT on both the gastrocnemius and soleus muscles against treatment on the gastrocnemius muscle alone. A total of 40 participants will be randomly assigned to one of two groups, receiving either a higher or lower dose of ESWT over four sessions. The study will assess various outcomes related to spasticity and ankle function before and after treatment at multiple time points.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old who have experienced a cerebral stroke and exhibit moderate to severe ankle plantar flexor spasticity.
Not a fit: Patients with recurrent strokes, other central nervous system diseases, or those who have recently received similar treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve mobility and quality of life for stroke patients suffering from ankle spasticity.
How similar studies have performed: Previous studies have shown positive outcomes with ESWT for spasticity, but this specific comparison of muscle groups is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject with Cerebral stroke and age more 20 2. The degree of spasticity of plantar flexor is more than 1.( grading with the modified Ashworth scale) 3. Stable vital sign Exclusion Criteria: 1. Recurrent cerebral stroke, traumatic brain injury, brain tumor or other brain related disease. 2. Other central nervous system diseases (SCI, Parkinson's disease), or other musculoskeletal disorders which affect the result of evaluating muscle spasticity. 3. Malignant tumor, coagulation disorder, infection or use of pace which were not suitable for Extracorporeal Shock Wave. 4. Received Extracorporeal Shock Wave or Botulinum injection for plantar flexor spasticity in recent 3 months. 5. Subjects who was unable to complete Extracorporeal Shock Wave or evaluation due to impaired cognition or aphasia.
Where this trial is running
Hsinchu
- National Taiwan University Hospital Hsin-Chu Branch — Hsinchu, Taiwan (RECRUITING)
Study contacts
- Principal investigator: Meng Ting Lin, MD — The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital
- Study coordinator: Yen-Hua Chen, Master
- Email: G54089@hch.gov.tw
- Phone: +8863-5326151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, stroke, spasticity, shock wave, ankle