An interventional study of fESWT in Stroke, Equinus Deformity and Spasticity, Muscle, sponsored by Teresa Mateu Campos. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Teresa Mateu Campos · Not applicable, Interventional, and Treatment
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 60 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →This is the only study on the registry with Teresa Mateu Campos as lead sponsor.
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Exclusion Criteria:
1 session of fESWT
Device: fESWT
3 sessions of fESWT (1 session per week for 3 consecutive weeks)
Device: fESWT
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.
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
Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Passive Ankle range of motion (PROM)
Measure with goniometer
Time frame: 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
Pain Score: from 0 (no pain) to 10 (the worst imaginable pain)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Before the first shock wave therapy and 1,4,8,12,20,24,36 and 48 weeks after the last session of ESWT.
Plan to share: No
Ran from Aug 2020 to primary completion in Sep 2024, 48 months.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 48 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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