An Early Phase 1 interventional study of Radial shock Wave therapy (3000 pulses, 5 Hz, 2.5 bar). and ARM B: Sham-radial shock Wave therapy in Stroke, Spasticity as Sequela of Stroke and Lower Limb Spasticity, sponsored by Parc de Salut Mar. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Parc de Salut Mar · Early Phase 1, Interventional, and Treatment
The goal of this pilot clinical trial is to determine whether radial extracorporeal shock wave therapy (rESWT), when used as an adjunct to ultrasound-guided botulinum toxin type A (BoNT-A) injections, can enhance the therapeutic effect of BoNT-A in adults with post-stroke lower-limb spasticity. The study will also evaluate the safety and tolerability of the combined treatment.
The main questions it aims to answer are:
Researchers will compare BoNT-A combined with active rESWT with BoNT-A combined with sham rESWT to determine whether the addition of active rESWT provides greater clinical benefit.
Participants will:
The SOLUTION study is a pilot, randomized, sham-controlled clinical trial designed to investigate the potential benefit of radial extracorporeal shock wave therapy (rESWT) as an adjunctive treatment to botulinum toxin type A (BoNT-A) for the management of post-stroke lower-limb spasticity.
Post-stroke spasticity is a common complication that may contribute to restricted joint mobility, abnormal limb positioning, impaired gait, pain, and limitations in functional activities. Botulinum toxin type A is an established treatment for focal spasticity. However, its therapeutic effect is temporary, and the duration of clinical benefit may be limited. Radial extracorporeal shock wave therapy is a non-invasive physical intervention that has been investigated as an adjunctive treatment for spasticity. The SOLUTION study was designed to investigate whether adding rESWT to BoNT-A could enhance the reduction in muscle spasticity and prolong the therapeutic effect of BoNT-A.
The study was conducted at the Neurorehabilitation Unit of the Physical Medicine and Rehabilitation Service of Hospital del Mar-Centre Esperança, Barcelona, Spain. The study protocol was evaluated and approved by the Clinical Research Ethics Committee of Parc de Salut Mar under project number 2022/10664/I. The protocol version evaluated by the committee was version 3, dated December 2, 2022, and the committee approval was documented in the meeting held on January 24, 2023.
Participants referred to the spasticity clinic were assessed for eligibility and, if eligible and willing to participate, were randomly allocated in a 1:1 ratio to one of two parallel treatment groups. Both groups received ultrasound-guided intramuscular botulinum toxin type A treatment. The intervention group additionally received active radial extracorporeal shock wave therapy, whereas the control group received a sham rESWT procedure.
Randomization was performed using a computer-generated random sequence. Allocation concealment was maintained by withholding the randomization codes until the predefined study measurements had been completed. Physicians from the Neurorehabilitation Unit were responsible for participant recruitment. The randomization sequence was generated by a physician blinded to participant identification. BoNT-A was administered by a physician using ultrasound guidance, while rESWT was administered by an experienced physiotherapist.
The study used a blinded assessment approach. Investigators involved in recruitment and data analysis were blinded to treatment allocation. The physiotherapist administering rESWT did not participate in follow-up visits or outcome data collection and was responsible only for recording adverse effects related to the rESWT procedure. In the sham group, participants received an initial stimulation intended to reproduce the sensory experience of treatment, followed by a progressive reduction in intensity to zero. Treatment allocation was disclosed after completion of the statistical analysis.
The botulinum toxin preparation used in the study was abobotulinumtoxinA (Dysport®). BoNT-A was administered according to the European consensus recommendations for the use of botulinum toxin type A in adult spasticity, with ultrasound used to guide the intramuscular injections.
Radial extracorporeal shock wave therapy was initiated approximately 24 hours after BoNT-A injection. Treatment was applied to the spastic triceps surae muscle group. Each active treatment session consisted of 3,000 pulses, with 1,500 pulses applied to the gastrocnemius muscle and 1,500 pulses to the soleus muscle, at a frequency of 5 Hz and an intensity of 2.5 bar. Three rESWT sessions were administered, at a frequency of one session per week for three consecutive weeks.
The sham rESWT procedure followed the same treatment schedule. Participants received an initial stimulation designed to provide a perceptible treatment experience, followed by a reduction in intensity to zero. This procedure was used as the sham comparator for the active rESWT intervention.
Both treatment groups received a session of instruction in stretching exercises targeting the injected muscle group. Participants were provided with a diary to record adherence to the prescribed exercises during the initial follow-up period.
Clinical assessments were performed at baseline, immediately before administration of BoNT-A and rESWT, and at 5 weeks, 3 months, and 6 months after BoNT-A injection. Outcome data were collected by an investigator blinded to treatment allocation.
The primary efficacy assessment evaluated changes in lower-limb spasticity using the Modified Ashworth Scale. Additional clinical assessments were used to characterize changes in muscle spasticity, passive ankle mobility, gait performance, muscle contracture characteristics, patient-perceived clinical improvement, pain, and treatment-related adverse effects.
The study was designed as a superiority trial comparing BoNT-A combined with active rESWT with BoNT-A combined with sham rESWT. The main hypothesis was that adjunctive rESWT would improve the effect of BoNT-A on lower-limb spasticity and increase the duration of the therapeutic response.
The planned sample size was 20 participants, with 10 participants allocated to each treatment group. The sample size calculation was based on the detection of a between-group difference of at least 1 point on the Modified Ashworth Scale, assuming a common standard deviation of 0.7, a two-sided alpha level of 0.05, 90% statistical power, and an anticipated 20% loss to follow-up. Given the pilot nature of the study and the small sample size, the findings were intended to provide preliminary estimates of treatment effects and information regarding the feasibility and safety of the combined intervention.
Safety was assessed throughout the treatment period. Adverse effects associated with rESWT were recorded using a predefined checklist including pain, local discomfort, worsening of pain between sessions, petechiae, muscular ecchymosis, and focal oedema. The use of orthoses during walking was also recorded.
The study was conducted at Hospital del Mar-Centre Esperança in Barcelona, Spain, during the period from January 2023 to January 2025.
The study was designed to determine whether the addition of rESWT to BoNT-A could provide an additional and sustained reduction in lower-limb spasticity compared with BoNT-A combined with sham rESWT. The results are intended to provide preliminary evidence to inform the design of future randomized clinical trials evaluating adjunctive rESWT in the management of post-stroke lower-limb spasticity.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Parc de Salut Mar is the lead sponsor of 182 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Fixed ankle contracture.
Ultrasound-guided abobotulinumtoxinA followed 24 hours later by three weekly sessions of radial ESWT (3000 pulses, 5 Hz, 2.5 bar).
Device: Radial shock Wave therapy (3000 pulses, 5 Hz, 2.5 bar). · Drug: Ultrasound-guided abobotulinumtoxin A
dentical BoNT-A protocol followed by sham radial ESWT using identical procedures without therapeutic energy.
Device: ARM B: Sham-radial shock Wave therapy · Drug: Ultrasound-guided abobotulinumtoxin A
Ultrasound-guided abobotulinumtoxinA followed 24 hours later by three weekly sessions of radial shock Wave therapy (3000 pulses, 5 Hz, 2.5 bar) vs Identical BoNT-A protocol followed by sham radial ESWT using identical procedures without therapeutic energy.
Sham-radial shock Wave therapy
Ultrasound-guided abobotulinumtoxin A for ARM A and ARM B
Modified Ashworth Scale (MAS) score
\*\*The Modified Ashworth Scale (MAS)\*\* is a 6-point categorical scale that measures resistance during passive muscle stretching. It is scored as follows: 0 = No increase in muscle tone; 1 = Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion; 1+ = Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout less than half of the remainder of the range of motion; 2 = More marked increase in muscle tone through most of the range of motion, but the affected part(s) are easily moved; 3 = Considerable increase in muscle tone, making passive movement difficult; 4 = Affected part(s) rigid in flexion or extension.
Time frame: Change in Modified Ashworth Scale (MAS) score from baseline to Week 5.
Tardieu Angle
The Tardieu angle is defined as the difference between the angle of arrest at low velocity and the angle of catch at high velocity. Measurement position: Patients are positioned supine with the knee in full extension and the subtalar joint stabilized.
Time frame: Weeks 5, Month 3, Month 6
Passive ankle range of motion
The passive range of motion (PROM) of the ankle will be measured using a handheld goniometer. The neutral ankle position will be defined as 90° (position 0). Dorsiflexion and plantarflexion angles will be recorded as positive values.
Time frame: Weeks 5, Month 3, Month 6
10-Metre Walk Test
Gait speed will be assessed using the 10-Meter Walk Test. Patients will be instructed to walk 10 meters as quickly and safely as possible, with or without the use of orthoses, as required. Gait speed will be recorded in meters per second (m/s).
Time frame: Weeks 5, Month 3, Month 6
Silfverskiöld Test
The Silfverskiöld test is used to identify isolated gastrocnemius contractures associated with various foot and ankle pathologies. Ankle dorsiflexion (DF) is measured with the knee extended and with the knee flexed to 90°. When ankle dorsiflexion increases with knee flexion, the equinus deformity is considered to be attributable to the gastrocnemius alone. Conversely, if the equinus deformity persists with knee flexion, it is considered to involve both the gastrocnemius and soleus muscles.
Time frame: Weeks 5, Month 3, Month 6
Global Impression of Change Scale
The Patient Global Impression of Change Scale is a 7-point scale ranging from "very much improved" to "very much worse" compared with baseline. It is scored as follows: 1. = Very much improved since the start of treatment. 2. = Much improved. 3. = Minimally improved. 4. = No change since the start of treatment. 5. = Minimally worse. 6. = Much worse. 7. = Very much worse since the start of treatment.
Time frame: Weeks 5, Month 3, Month 6
Visual Analog Scale (VAS) for Pain
Pain related to spasticity will be assessed using a 10-point Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable.
Time frame: Weeks 5, Month 3, Month 6
Adverse events and treatment tolerability
Adverse events will be recorded using a checklist with a dichotomous (yes/no) record of the most common adverse effects reported in the literature, including pain, bruising or exacerbation of pain between sessions, petechiae, muscle ecchymosis, and focal edema. Concomitant use of orthoses will be recorded dichotomously (yes/no)
Time frame: Weeks 5, Month 3, Month 6
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified individual participant data may be made available upon reasonable request after publication of the primary manuscript, subject to approval by the Sponsor, ethics requirements and applicable data protection legislation. Supporting documents (protocol and data dictionary) may also be shared where appropriate
Supporting information: Study protocol, Informed consent form
Time frame: Until 1 year after publication
Access criteria: Individual participant data (IPD) may be shared with qualified researchers upon reasonable request for scientifically valid research purposes, including secondary analyses, replication studies, or meta-analyses. Requests must include a research proposal describing the objectives, planned analyses, and statistical methods, and may be subject to independent scientific and ethical review. Data sharing will be conducted following approval of the request and execution of an appropriate data-sharing agreement, in accordance with applicable privacy, confidentiality, and data protection requirements. Requests will be reviewed by the study investigators or an appointed independent review committee based on scientific merit, feasibility, ethical considerations, and compliance with applicable regulations.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.