StrokeSWT-PINCT06815328
Efficacy of Shock Wave Therapy in Post-Stroke Muscle Spasticity Management
A study testing Shock Wave Therapy (SWT) and Active Comparator - Conventional Therapy in people with Stroke and Spasticity, run by University of Oviedo at 1 site in Spain.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of shock wave therapy (SWT) in reducing muscle spasticity in patients who have suffered a stroke. The main questions it aims to answer are: Does SWT reduce muscle tone and improve joint range of motion in post-stroke patients with spasticity? Does… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Spasticity, Post-stroke
- What is being tested?
- Shock Wave Therapy (SWT) and Active Comparator - Conventional Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 15 Mar 2025to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
"Inclusion Criteria":
- Adults aged 18 years or older.
- Confirmed diagnosis of stroke (ischemic or hemorrhagic) at least 6 months prior to enrollment.
- Clinically diagnosed muscle spasticity, measured by the Modified Ashworth Scale (MAS), with a score of 0 to 3.
- Stable medical condition that permits participation in the intervention.
- No significant changes in spasticity-related treatment for at least 3 months prior to the study.
- Ability to provide written informed consent to participate in the study.
- Ability to attend weekly sessions and follow-up visits as required.
"Exclusion Criteria":
- Severe spasticity or contractures unresponsive to prior treatments.
- Contraindications to Shock Wave Therapy, including:
- Local infections in the treatment area.
- Known or suspected malignancy near the treatment site.
- Severe bleeding disorders or anticoagulation therapy.
- Pregnancy.
- Neurological conditions other than stroke that could interfere with study outcomes (e.g., Parkinson's disease, multiple sclerosis).
- Recent treatments that might interfere with spasticity assessment, including:
- Injections of botulinum toxin within the past 6 months.
- Recent surgery or other interventions targeting spasticity.
- Cognitive impairment or other conditions preventing the participant from following instructions or completing study tasks.
- Severe cardiovascular, renal, or hepatic disease that might complicate therapy or participation.
- Inability to commit to follow-up visits or complete the intervention protocol due to logistical, mobility, or health-related issues.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
University of Oviedo
Oviedo, Principality of Asturias, 33193
María Blanco Díaz, PhD., +34667681858, blancomaria@uniovi.es
About this study
Official title: Efficacy of Shock Wave Therapy in Patients with Muscle Spasticity After a Stroke
The goal of this clinical trial is to evaluate the efficacy and safety of shock wave therapy (SWT) in reducing muscle spasticity in patients who have suffered a stroke. The main questions it aims to answer are:
Does SWT reduce muscle tone and improve joint range of motion in post-stroke patients with spasticity? Does SWT improve the quality of life for these patients? What side effects, if any, occur during or after SWT? Researchers will compare SWT to conventional spasticity treatments to determine its effectiveness and potential advantages.
Read more
Participants will:
Undergo SWT sessions as part of their rehabilitation protocol over a period of 8 weeks.
Attend follow-up visits to assess muscle tone, joint mobility, and overall functional improvement.
Complete quality-of-life questionnaires to measure the therapy's impact on daily living.
Read the detailed description
This study aims to assess the efficacy and safety of Shock Wave Therapy (SWT) as a non-invasive treatment for muscle spasticity in post-stroke patients. Muscle spasticity is a major complication in neurorehabilitation, affecting mobility, functionality, and quality of life. Conventional treatments, including physical therapy, oral medications, and botulinum toxin injections, have limitations such as variable efficacy, side effects, and accessibility issues. SWT has gained interest as a potential alternative, but high-quality evidence regarding its effectiveness and safety in this population remains scarce.
Study Design and Rationale The study is designed as a prospective, randomized controlled trial (RCT) comparing SWT with conventional treatment approaches. SWT delivers mechanical acoustic waves to targeted spastic muscles, aiming to reduce hypertonicity and neuromuscular dysfunction. The hypothesized mechanism of action involves neuromuscular modulation, local tissue repair promotion, and increased vascularization, which may improve muscle tone, functional mobility, and overall patient outcomes.
Participants will undergo weekly SWT sessions for 8 weeks, each lasting approximately 30 minutes. Treatment will be applied to specific muscle groups, such as the elbow flexors, wrist flexors, or calf muscles, based on baseline assessments. The frequency, intensity, and duration of SWT will follow current clinical guidelines.
The control group will receive standard care, which may include physical therapy techniques such as stretching, therapeutic exercises, and pharmacological management as per clinical indication. The study will implement a blinded assessment process, where outcome evaluators will not be aware of group allocation.
Technical Aspects of SWT Application The SWT intervention will be conducted using a focused or radial shock wave device, applying preset intensity levels tailored to spastic muscle groups. The wave frequency and energy flux density will be determined based on prior research in musculoskeletal rehabilitation. SWT will be delivered at specific treatment points over affected muscles, with adjustments as necessary according to patient response and tolerability.
Data Collection and Monitoring Data will be collected at baseline, mid-treatment (week 4), and post-treatment (week 8) using standardized clinical assessment tools. The study will also monitor for adverse events, including pain, bruising, or transient increases in spasticity, to establish a safety profile for SWT in this population.
Potential Clinical Impact If SWT demonstrates clinically significant benefits, this study could support its integration into routine post-stroke rehabilitation protocols. The findings may provide guidance for rehabilitation professionals, contribute to cost-effective management strategies, and inform clinical decision-making regarding spasticity treatment.
Ethical Compliance This study adheres to the principles of the Declaration of Helsinki and has been submitted for approval to the appropriate institutional review boards. Participants will provide written informed consent before enrollment. All collected data will be handled following confidentiality and ethical guidelines.
- Conditions
- Stroke, Spasticity, Post-stroke, Muscle Hypertonia, Neurological Disorders, Physiotherapy
- Being tested
- Shock Wave Therapy (SWT), Active Comparator - Conventional Therapy
- Keywords
- Shock Wave Therapy, Post-Stroke Spasticity, Non-Invasive Therapy, Quality of Life, Neurological physical therapy, Muscle Hypertonia Treatment
- Medical subject headings
- Stroke, Muscle Spasticity, Muscle Hypertonia, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock Wave Therapy (SWT)Other
Focused SWT sessions targeting spastic muscle groups. Parameters include standardized frequency, energy level, and session duration (30 minutes per session, once weekly for 8 weeks). This therapy aims to reduce muscle spasticity, improve joint mobility, and enhance quality of life.
Standard care consisting of physical therapy sessions (e.g., stretching, mobility exercises) and/or prescribed medications for spasticity management. The therapy follows clinical guidelines and is administered with the same frequency and duration (once weekly for 8 weeks) as the experimental intervention.
Active Comparator - Conventional TherapyOther
Standard care consisting of physical therapy sessions (stretching, mobility exercises) and/or prescribed medications for spasticity management.
Follows clinical guidelines and is administered with the same frequency and duration (once weekly for 8 weeks) as the experimental intervention.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Shock Wave Therapy (SWT) | Experimental | Participants in this arm will receive Shock Wave Therapy applied to spastic muscle groups identified during the baseline assessment. The therapy will be delivered using a focused SWT device with standardized parameters (e.g., frequency, energy level, and duration). Each session will last approximately 30 minutes and will be administered once a week for 8 weeks. The intervention targets neuromuscular modulation to reduce spasticity and improve joint mobility. Receives: Other: Shock Wave Therapy (SWT) |
| Conventional Therapy | Active comparator | Participants in this arm will receive standard care for post-stroke spasticity, which may include physical therapy sessions focused on stretching, strengthening, and mobility exercises, alongside medications if prescribed (e.g., muscle relaxants). The therapy will follow current clinical guidelines and will be administered with the same frequency and duration (once a week for 8 weeks) to ensure comparability with the experimental arm. Receives: Other: Active Comparator - Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Muscle Spasticity
Measurement of changes in muscle tone using the Modified Ashworth Scale (MAS) from baseline to the end of the treatment period. The MAS ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).
Units of Measure: Score from 0 to 4. Lower MAS scores indicate reduced spasticity.
Measured: Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).
Secondary outcomes (5)
Change in Joint Range of Motion
Measurement of changes in joint range of motion (in degrees) using a goniometer, focusing on affected joints. A higher degree value indicates better joint mobility.
Measured: Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).
Change in Quality of Life
Change in patient-reported quality of life using the Stroke Impact Scale (SIS). Units of Measure: Score from 0 to 100. Higher scores indicate better quality of life.
Measured: Baseline and at 12 weeks (follow-up).
Grip Strength
Change in grip strength, measured using a hand dynamometer. A higher grip strength value indicates better muscle function and recovery.
Units of Measure: Kilograms (kg).
Measured: Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).
Incidence of Treatment-Related Adverse Events
Measurement of the number and nature of adverse events reported during the study, including pain, discomfort, or other side effects related to the interventions.
Units of Measure: Count of reported adverse events.
Measured: Throughout the study period (12 weeks).
Walking Speed
Change in walking speed, assessed using the 10-Meter Walk Test (10MWT). A shorter time to complete the 10-meter distance indicates better functional mobility.
Units of Measure: Time in seconds (s).
Measured: Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start15 Mar 2025 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Blanco Diaz, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815328
- Sponsor's protocol ID
- Universidad de Oviedo
- Acronym
- SWT-PI
- Status last verified
- Mar 2025
- First submitted
- 24 Jan 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) collected in this study will not be shared due to privacy concerns, ethical considerations, and regulatory restrictions. Only aggregated results will be disseminated through scientific publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Shock Wave Therapy in Patients with Muscle Spasticity After a Stroke
- ClinicalTrials.gov ID
- NCT06815328
- Acronym / sponsor ID
- SWT-PI / Universidad de Oviedo
- Conditions
- Stroke, Spasticity, Post-stroke, Muscle Hypertonia, Neurological Disorders, Physiotherapy
- Keywords
- Shock Wave Therapy, Post-Stroke Spasticity, Non-Invasive Therapy, Quality of Life, Neurological physical therapy, Muscle Hypertonia Treatment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the efficacy and safety of shock wave therapy (SWT) in reducing muscle spasticity in patients who have suffered a stroke. The main questions it aims to answer are:
Does SWT reduce muscle tone and improve joint range of motion in post-stroke patients with spasticity? Does SWT improve the quality of life for these patients? What side effects, if any, occur during or after SWT? Researchers will compare SWT to conventional spasticity treatments to determine its effectiveness and potential advantages.
Participants will:
Undergo SWT sessions as part of their rehabilitation protocol over a period of 8 weeks.
Attend follow-up visits to assess muscle tone, joint mobility, and overall functional improvement.
Complete quality-of-life questionnaires to measure the therapy's impact on daily living.
Detailed description
This study aims to assess the efficacy and safety of Shock Wave Therapy (SWT) as a non-invasive treatment for muscle spasticity in post-stroke patients. Muscle spasticity is a major complication in neurorehabilitation, affecting mobility, functionality, and quality of life. Conventional treatments, including physical therapy, oral medications, and botulinum toxin injections, have limitations such as variable efficacy, side effects, and accessibility issues. SWT has gained interest as a potential alternative, but high-quality evidence regarding its effectiveness and safety in this population remains scarce.
Study Design and Rationale The study is designed as a prospective, randomized controlled trial (RCT) comparing SWT with conventional treatment approaches. SWT delivers mechanical acoustic waves to targeted spastic muscles, aiming to reduce hypertonicity and neuromuscular dysfunction. The hypothesized mechanism of action involves neuromuscular modulation, local tissue repair promotion, and increased vascularization, which may improve muscle tone, functional mobility, and overall patient outcomes.
Participants will undergo weekly SWT sessions for 8 weeks, each lasting approximately 30 minutes. Treatment will be applied to specific muscle groups, such as the elbow flexors, wrist flexors, or calf muscles, based on baseline assessments. The frequency, intensity, and duration of SWT will follow current clinical guidelines.
The control group will receive standard care, which may include physical therapy techniques such as stretching, therapeutic exercises, and pharmacological management as per clinical indication. The study will implement a blinded assessment process, where outcome evaluators will not be aware of group allocation.
Technical Aspects of SWT Application The SWT intervention will be conducted using a focused or radial shock wave device, applying preset intensity levels tailored to spastic muscle groups. The wave frequency and energy flux density will be determined based on prior research in musculoskeletal rehabilitation. SWT will be delivered at specific treatment points over affected muscles, with adjustments as necessary according to patient response and tolerability.
Data Collection and Monitoring Data will be collected at baseline, mid-treatment (week 4), and post-treatment (week 8) using standardized clinical assessment tools. The study will also monitor for adverse events, including pain, bruising, or transient increases in spasticity, to establish a safety profile for SWT in this population.
Potential Clinical Impact If SWT demonstrates clinically significant benefits, this study could support its integration into routine post-stroke rehabilitation protocols. The findings may provide guidance for rehabilitation professionals, contribute to cost-effective management strategies, and inform clinical decision-making regarding spasticity treatment.
Ethical Compliance This study adheres to the principles of the Declaration of Helsinki and has been submitted for approval to the appropriate institutional review boards. Participants will provide written informed consent before enrollment. All collected data will be handled following confidentiality and ethical guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Shock Wave Therapy (SWT) | Experimental | Other: Shock Wave Therapy (SWT)Participants in this arm will receive Shock Wave Therapy applied to spastic muscle groups identified during the baseline assessment. The therapy will be delivered using a focused SWT device with standardized parameters (e.g., frequency, energy level, and duration). Each session will last approximately 30 minutes and will be administered once a week for 8 weeks. The intervention targets neuromuscular modulation to reduce spasticity and improve joint mobility. |
| Conventional Therapy | Active comparator | Other: Active Comparator - Conventional TherapyParticipants in this arm will receive standard care for post-stroke spasticity, which may include physical therapy sessions focused on stretching, strengthening, and mobility exercises, alongside medications if prescribed (e.g., muscle relaxants). The therapy will follow current clinical guidelines and will be administered with the same frequency and duration (once a week for 8 weeks) to ensure comparability with the experimental arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shock Wave Therapy (SWT)Focused SWT sessions targeting spastic muscle groups. Parameters include standardized frequency, energy level, and session duration (30 minutes per session, once weekly for 8 weeks). This therapy aims to reduce muscle spasticity, improve joint mobility, and enhance quality of life. Standard care consisting of physical therapy sessions (e.g., stretching, mobility exercises) and/or prescribed medications for spasticity management. The therapy follows clinical guidelines and is administered with the same frequency and duration (once weekly for 8 weeks) as the experimental intervention. | Other | Experimental: Shock Wave Therapy (SWT) |
| Active Comparator - Conventional TherapyStandard care consisting of physical therapy sessions (stretching, mobility exercises) and/or prescribed medications for spasticity management. Follows clinical guidelines and is administered with the same frequency and duration (once weekly for 8 weeks) as the experimental intervention. | Other | Conventional Therapy |
Primary outcome
Change in Muscle Spasticity
Time frame: Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).
Measurement of changes in muscle tone using the Modified Ashworth Scale (MAS) from baseline to the end of the treatment period. The MAS ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Units of Measure: Score from 0 to 4. Lower MAS scores indicate reduced spasticity.
5 secondary outcomes
Change in Joint Range of Motion
Time frame: Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).
Change in Quality of Life
Time frame: Baseline and at 12 weeks (follow-up).
Grip Strength
Time frame: Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).
Incidence of Treatment-Related Adverse Events
Time frame: Throughout the study period (12 weeks).
Walking Speed
Time frame: Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: No. The individual participant data (IPD) collected in this study will not be shared due to privacy concerns, ethical considerations, and regulatory restrictions. Only aggregated results will be disseminated through scientific publications and presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shock Wave Therapy (SWT) and Active Comparator - Conventional Therapy in people with Stroke and Spasticity, run by University of Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Blanco Díaz, PhD. (+34667681858, blancomaria@uniovi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Muscle Spasticity (time frame: Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.