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

ConditionsStrokeSpasticityPost-strokeMuscle HypertoniaNeurological DisordersPhysiotherapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oviedo

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Severe spasticity or contractures unresponsive to prior treatments.

Local infections in the treatment area.

Known or suspected malignancy near the treatment site.

Severe bleeding disorders or anticoagulation therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Shock Wave Therapy (SWT)

    Other intervention

    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

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Experimental: Shock Wave Therapy (SWT)Experimental treatment 1 intervention
Group B: Conventional TherapyActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).
2

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.

Time frame
Baseline and at 12 weeks (follow-up).
3

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).

Time frame
Baseline, at 10 weeks (end of intervention), and at 12 weeks (follow-up).
4

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.

Time frame
Throughout the study period (12 weeks).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oviedo

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: