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The goal of this study is to evaluate long term effects of focused extracorporeal shock wave therapy (fESWT) on triceps surae spasticity in stroke patients according to the number of sessions applied.
Hypothesis: 3 sessions of fESWT on equinus foot in stroke patients improve spasticity and functionality for longer term than 1 session of fESWT.
Spasticity is a common complication as a consequence of suffering a stroke and one of the most important causes of disability in this pathology.
Global data estimate that 12 million people world-wide suffer from spasticity of the upper or lower limb. Equinus foot is the most common pattern of the lower extremities.
Previous studies have reported that extracorporeal shock wave therapy (ESWT) is a safe and noninvasive alternative treatment for spasticity.
Although the authors have shown a beneficial clinical effect of the ESWT, outcomes and duration of effect varied across studies.
This is a prospective randomized controlled trial. 60 stroke patients with spastic equinus foot post stroke will enroll in this study.
The participants will be randomly divided into two groups. The first group (control group) will receive 1 session of fESWT, while the second group (experimental group) will receive 3 sessions of fESWT, once a week, for 3 consecutive weeks.
Therapy will be administered directly to the muscle bellies of the gastrocnemius medial and lateral and soleus. The muscle belly will be located by ultrasonography.
The primary outcome is modified Ashworth scale. Secondary outcomes are passive range of ankle motion, mobility and balance test, spasm frequency scale and quality of life scales.
Participants will be evaluated by the same researcher before the first shock wave therapy and after the last session of fESWT will be done periodic revisions on weeks 1, 4, 8, 12, 20, 24, 36 and 48. Adverse events will be monitored during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GROUP 1 | Active Comparator | 1 session of fESWT |
|
| GROUP 2 | Experimental | 3 sessions of fESWT (1 session per week for 3 consecutive weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fESWT | Device | Shock wave therapy will be applied with Duolith SD1 device (Storz Medical, Tagerwilen, Switzerland). Therapy will be administered in the gastrocnemius medial and lateral and in the soleus muscles. Parameters: 0.15mJ/mm2, 4-5 Hz, 1500 shoots/muscle. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Ashworth Scale (MAS) | A manual measurement of the resistance os muscles during passive stretching. Score from 0 to 4, higher scores mean a worse outcome | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. |
| Measure | Description | Time Frame |
|---|---|---|
| Passive Ankle range of motion (PROM) | Measure with goniometer | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. |
| Visual Analogue Scale (VAS) Pain Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Teresa Mª Mateu Campos | Contact | +34666803771 | teremateuc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Teresa Mª Mateu Campos | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Plana | Recruiting | Vila-real | Castellon | 12540 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28918085 | Background | Guo P, Gao F, Zhao T, Sun W, Wang B, Li Z. Positive Effects of Extracorporeal Shock Wave Therapy on Spasticity in Poststroke Patients: A Meta-Analysis. J Stroke Cerebrovasc Dis. 2017 Nov;26(11):2470-2476. doi: 10.1016/j.jstrokecerebrovasdis.2017.08.019. Epub 2017 Sep 13. | |
| 25364134 | Background | Lee JY, Kim SN, Lee IS, Jung H, Lee KS, Koh SE. Effects of Extracorporeal Shock Wave Therapy on Spasticity in Patients after Brain Injury: A Meta-analysis. J Phys Ther Sci. 2014 Oct;26(10):1641-7. doi: 10.1589/jpts.26.1641. Epub 2014 Oct 28. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D004863 | Equinus Deformity |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Pain Score: from 0 (no pain) to 10 (the worst imaginable pain)
| Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. |
| 10 Meters Walk Test | Measure the gait speed | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. |
| Test Up and Go (TUG) | Asses the mobility and balance | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. |
| Spasm Frequency Scale | Estimate muscle spams. Score 0 (no spams) to 4 (>10 spams) | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. |
| Test 6 Minutes Walking | Asses walking resistance | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. |
| Fall Skip Device | Assesment of fall risk | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. |
| Stroke Quality of Life Scale (ECVI-38) | A questionnaire of 38 items: from 1 (no problem) to 190 (the worst situation) | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. |
| Self Report Spasticity Scale (SRSS) | A questionnaire of 8 items: from 0 (nothing) to 24 (cpmpletely) | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. |
| 28646841 | Background | Taheri P, Vahdatpour B, Mellat M, Ashtari F, Akbari M. Effect of Extracorporeal Shock Wave Therapy on Lower Limb Spasticity in Stroke Patients. Arch Iran Med. 2017 Jun;20(6):338-343. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D005532 | Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009135 | Muscular Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |