Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Post-stroke spasticity is a common complication affecting the neurological recovery, self-care daily activities and patients' quality of life. Extracorporeal shock waves (ESWT) have been proven therapeutic effects on decreasing spasticity and regaining function. Stroke patients often suffer ankle plantar flexor spasticity with poor ankle movement control, leading to abnormal gait patterns and risk of falling; local pain appears as well in the ankle. Research showed application of ESWT to lower extremity spasticity reduced ankle plantar flexor spasticity, ankle pain and increased the range of ankle motion. However, the current study did not investigate the effect of ESWT on different muscles in patients with post-stroke ankle spasticity. Therefore, this study will compare the effect of focused ESWT on combination of the gastrocnemius and soleus muscles to gastrocnemius muscle alone in the post-stroke ankle plantar flexor spasticity.
This study design was a single-blind randomized controlled trial and planned to recruit 40 chronic stroke patients with ankle plantar flexor spasticity. The patients were randomly assigned to two groups. The experimental group received focused ESWT to gastrocnemius and soleus muscles (a total of 4000 shots per session), while the control group received focused ESWT to gastrocnemius muscle (2000 shots per session). Patients in both groups underwent a total of 4 sessions ESWT, twice a week for two consecutive weeks. The primary outcome was modified Ashworth scale; the secondary outcomes were modified Tardieu scale, passive range of ankle motions and timed up and go test, and strain elastography. The outcomes were assessed before ESWT and after ESWT at 1, 4, 12, and 24 week.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ESWT to gastrocnemius and soleus | Experimental | ESWT to gastrocnemius and soleus muscles (2000 shots for each muscle, a total of 4000 shots per session) |
|
| ESWT to gastrocnemius | Active Comparator | ESWT to gastrocnemius muscle (2000 shots per session) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal shock waves | Device | Both group received extracorporeal shock waves therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Ashworth Scale (MAS) | Modified Ashworth Scale (MAS). Score from 0 to 4, higher scores mean a worse outcome | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Level of mobility and balance | Timed Up & Go Test | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 |
| Ultrasound evaluations |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yen-Hua Chen, Master | Contact | +8863-5326151 | 523504 | G54089@hch.gov.tw |
| Shu-mei Yang, MD | Contact | 0972653754 | b99401109@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Meng Ting Lin, MD | The Department of Physical Medicine and Rehabilitation, National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Hsin-Chu Branch | Recruiting | Hsinchu | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21707868 | Background | Ward AB. A literature review of the pathophysiology and onset of post-stroke spasticity. Eur J Neurol. 2012 Jan;19(1):21-7. doi: 10.1111/j.1468-1331.2011.03448.x. Epub 2011 Jun 27. | |
| 19601786 | Background | Mariotto S, de Prati AC, Cavalieri E, Amelio E, Marlinghaus E, Suzuki H. Extracorporeal shock wave therapy in inflammatory diseases: molecular mechanism that triggers anti-inflammatory action. Curr Med Chem. 2009;16(19):2366-72. doi: 10.2174/092986709788682119. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
participants
Strain elastography of gastrocnemius muscle
| T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 |
| 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. | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 |
| Change in modified Tardieu scale (mTS) | Modified Tardieu scale (mTS). Score from 0 to 5, higher scores mean a worse outcome | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 |
| Change in Passive ROM of the ankle in dorsiflexion | Passive ankle Range of Motion (PROM) | T0 Enrollment, T1 after 1 week from T0, T2 after 4 weeks from T0, T3 after 12 weeks from T0, T4 after 24 weeks from T0 |
| 28971038 | Background | Yoon SH, Shin MK, Choi EJ, Kang HJ. Effective Site for the Application of Extracorporeal Shock-Wave Therapy on Spasticity in Chronic Stroke: Muscle Belly or Myotendinous Junction. Ann Rehabil Med. 2017 Aug;41(4):547-555. doi: 10.5535/arm.2017.41.4.547. Epub 2017 Aug 31. |
| 34566855 | Background | Fan T, Zhou X, He P, Zhan X, Zheng P, Chen R, Li R, Li R, Wei M, Zhang X, Huang G. Effects of Radial Extracorporeal Shock Wave Therapy on Flexor Spasticity of the Upper Limb in Post-stroke Patients: Study Protocol for a Randomized Controlled Trial. Front Neurol. 2021 Sep 9;12:712512. doi: 10.3389/fneur.2021.712512. eCollection 2021. |
| 27149465 | Result | Li TY, Chang CY, Chou YC, Chen LC, Chu HY, Chiang SL, Chang ST, Wu YT. Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke: A Prospective, Randomized, Single Blind, Controlled Trial. Medicine (Baltimore). 2016 May;95(18):e3544. doi: 10.1097/MD.0000000000003544. |
| 39354619 | Derived | Yang SM, Chen YH, Lu YL, Wu CH, Chen WS, Lin MT. The dose effectiveness of extracorporeal shockwave on plantar flexor spasticity of ankle in stroke patients: a randomized controlled trial. J Neuroeng Rehabil. 2024 Oct 1;21(1):176. doi: 10.1186/s12984-024-01473-z. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |