Equinus Deformity, Spasticity, Muscle, Stroke
Conditions
Keywords
Stroke, Equinus Deformity, Extracorporeal Shock Wave Therapy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEfESWT
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.
Sponsors
Teresa Mateu Campos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age greater than 18 years old * Time from stroke (ischemic o hemorrhagic) onset of at least 6 months * Spastic equinus foot: triceps surae tone grade at least 1+ on the MAS score * Ability to walk alone with or without aids
Exclusion criteria
* Fixed ankle joint contracture * Severe medical problems * Treatment of the affected leg with botulinum toxin in the las 6 months * Cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Ashworth Scale (MAS) | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. | A manual measurement of the resistance os muscles during passive stretching. Score from 0 to 4, higher scores mean a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS) Pain Score | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. | Pain Score: from 0 (no pain) to 10 (the worst imaginable pain) |
| 10 Meters Walk Test | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. | Measure the gait speed |
| Test Up and Go (TUG) | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. | Asses the mobility and balance |
| Spasm Frequency Scale | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. | Estimate muscle spams. Score 0 (no spams) to 4 (\>10 spams) |
| Passive Ankle range of motion (PROM) | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. | Measure with goniometer |
| Fall Skip Device | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. | Assesment of fall risk |
| Stroke Quality of Life Scale (ECVI-38) | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. | A questionnaire of 38 items: from 1 (no problem) to 190 (the worst situation) |
| Self Report Spasticity Scale (SRSS) | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. | A questionnaire of 8 items: from 0 (nothing) to 24 (cpmpletely) |
| Test 6 Minutes Walking | Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT. | Asses walking resistance |
Countries
Spain
Contacts
Primary ContactTeresa Mª Mateu Campos
Outcome results
None listed