Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Spain / NCT06815328
Starting soon Not applicable

Efficacy of Shock Wave Therapy in Post-Stroke Muscle Spasticity Management

NCT06815328 · tracked via the Priya Life Science Spain tracker
Sponsor
University of Oviedo
Phase
Not applicable
Started
2025-03-15
Last updated
2025-03-12

Condition(s) studied

StrokeSpasticityPost-strokeMuscle HypertoniaNeurological DisordersPhysiotherapy

Investigational drug(s) / intervention(s)

Shock Wave Therapy (SWT)Active Comparator - Conventional Therapy

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.

Active Comparator - Conventional Therapy: 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 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
"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.

Primary outcome measure(s)

  • Change in Muscle Spasticity — 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.

Trial sites (1)

FacilityCityRegionStatus
University of Oviedo Oviedo Principality of Asturias

More University of Oviedo trials in Spain

Clinical and Psychosocial Factors Associated With Physical Activity Level in Adults With Marfan Syndrome Starting soon
Efficacy and Feasibility of an eHealth Intervention for Pregnant Women on Diet, Physical Activity and Knowledge Related to Pregnancy Active, not recruiting
Association Between Weekly Strength Training Load and Perceived Physical Performance in Non-Professional Soccer Players Active, not recruiting
Residual Athletic Identity, Body Image, and Emotional Symptoms in Retired Rhythmic Gymnasts Starting soon
Influence of Training Surface and Mechanical Load on the Prevalence of Patellofemoral Pain in Recreational Runners Active, not recruiting

Other trials for the same condition

Immersive Functional Virtual Reality in People With Acquired Brain Injury and Unilateral Spatial Neglect Starting soon
Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity Recruiting
Effects of Peripheral Somatosensory Stimulation Through Mechanical Pressure on Lower Limb Muscle Strength in Stroke Survivors Starting soon
Stroke Thrombectomy and Aneurysm Registry Recruiting
Effectiveness of an mHealth Intervention, Based on Rehabilitation and a Personalised Nutrition Plan, in the Recovery and Improvement of Dysphagia in Patients Diagnosed With Stroke Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06815328 on ClinicalTrials.gov ↗ ← All trials in Spain