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
Among 321 studies in Stroke with a site in Spain — 71 open to participants now, 89 under way, 6 of them phase 3. Stroke · Spain.
Among the 321 studies in Stroke with a site in Spain, this one is the 134th largest by planned enrollment of the 244 interventional ones that give a count, is one of 21 that started in 2020, is one of 158 with no phase, reaches primary completion later than 11 of the 88 other live ones, and was the 264th registered.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
Browse Stroke studies →71 of the 321 studies in Stroke with a site in Spain are open now. Recruiting first, the newest first:
Neuron, Spain · Sites in Spain
Hospital Universitari Vall d'Hebron Research Institute · Sites in Spain
Hospital Universitari Vall d'Hebron Research Institute · Sites in Spain, Belgium, Germany and 3 more countries
Ancor Rebassa Cabrera · Sites in Spain
Dr. Yaroslav Winter · Sites in Spain, Czechia, Germany and 1 more country
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
321 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 20 · Phase 3 44 · Phase 4 21
First in 1998; this study’s year is marked. 21 started in 2020.
This study's planned enrollment of 60 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Median enrollment 70 across the 244 interventional studies, 250 across the 77 observational. Of the 197 that completed or were terminated, 33 (17%) have results posted.
This tab as a report to print or save as PDF → With an account.
82 of 321 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Teresa Mateu Campos as lead sponsor.
Teresa Mateu Campos has 1 study filed under Stroke — fewer than ten, so there is no comparison to draw.
24 of the studies in Stroke with a site in Spain that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05065216Phase 3DiaMedica Therapeutics IncTreatment of Acute Ischemic Stroke (ReMEDy2 Trial) | 2026-12 |
| NCT06296082Phase 3Universiteit AntwerpenComparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity | 2026-12-30 |
| NCT05691244Phase 3Pharmazz, Inc.Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke | 2027-09 |
| NCT07357285iVascular S.L.U.Safety and Efficacy Evaluation of the iNstroke 4F Thromboaspiration Catheter in Patients With Acute Ischaemic Stroke Due to Primary Distal Medium Vessel Occlusions (DMVO) | 2026-11 |
| NCT07497464Alfredo Lerín CalvoValidity of an Open-access Handedness Recognition Task in Stroke Patients | 2026-11 |
Among the 321 studies in Stroke with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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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