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

NCT06815328 | Not Yet Recruiting

• 1 other identifier: Universidad de Oviedo
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).

Secondary Outcomes (5)

• Change in Joint Range of Motion

  Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).

• Change in Quality of Life

  Baseline and at 12 weeks (follow-up).

• Grip Strength

  Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).

• Incidence of Treatment-Related Adverse Events

  Throughout the study period (12 weeks).

• Walking Speed

  Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).

Study Arms (2)

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.

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.

Other: Active Comparator - Conventional Therapy

Interventions

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.

Experimental: Shock Wave Therapy (SWT)

Active Comparator - Conventional Therapy OTHER

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.

Conventional Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oviedo: lead

Study Sites (1)

University of Oviedo

Oviedo, Principality of Asturias, 33193, Spain

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity; Muscle Hypertonia; Nervous System Diseases

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

María Blanco Díaz, PhD.

CONTACT

+34667681858; blancomaria@uniovi.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Researcher, Department of Surgery and Medical-Surgical Specialties, University of Oviedo

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 7, 2025
• Study Start: March 15, 2025
• Primary Completion: March 30, 2025
• Study Completion: April 30, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)