Extracorporeal Shock Wave Therapy on Spastic Equinus Foot in Stroke Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTeresa Mateu Campos
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Fixed ankle joint contracture
Severe medical problems
Treatment of the affected leg with botulinum toxin in the las 6 months
Cognitive impairment
Trial design
Design model
Parallel
Treatments tested in this trial
fESWT
DeviceShock 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: GROUP 1Active comparator 1 intervention
Group B: GROUP 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Teresa Mateu Campos
Lead sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor institution
Source ClinicalTrials.gov