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Recruiting NCT07119801

Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity

No phase Interventional Stroke Spastic Hemiplegia Extracorporal Shockwave Therapy (ESWT)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Radial Extracorporeal Shock Wave Therapy, Conventional rehabilitation.
Who it may be relevant to
Registry conditions: Stroke, Spastic Hemiplegia, Extracorporal Shockwave Therapy (ESWT). Basic parameters: 35 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Clinical and Ultrasonographic Evaluation of the Efficacy of Extracorporeal Shock Wave Therapy (ESWT) in Post-Stroke Spasticity: A Randomized Controlled Trial

Overview

This research evaluate the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) for treating spasticity in the wrist flexor muscles (flexor carpi ulnaris - FCU and flexor carpi radialis - FCR) of chronic stroke patients. Spasticity, a common complication after a stroke, causes muscle stiffness, pain, and functional limitation, leading to increased healthcare costs and a lower quality of life. Current treatments like medication and injections have significant drawbacks, such as side effects and high costs, creating a need for new, non-invasive, and effective methods. The study highlights that traditional methods for assessing spasticity, like the Modified Ashworth Scale (MAS), are subjective. It proposes using objective, non-invasive ultrasound techniques-specifically strain elastography (to measure muscle stiffness) and echogenicity (to assess muscle tissue quality)-for a more reliable evaluation. The primary goal of this research is to be the first to investigate the short- and long-term effects of ESWT on the FCR and FCU muscles using these objective ultrasound measures alongside traditional clinical scales. The findings are expected to help standardize ESWT treatment protocols and promote the use of objective ultrasound data for the management and follow-up of post-stroke spasticity.

Interventions

  • Device Radial Extracorporeal Shock Wave Therapy
    rESWT will be administered to the FCU and FCR muscles two days per week over a period of four weeks (8 sessions in total). The point of application will be selected as the center of the muscle belly for both the FCU and FCR. Each muscle will receive 2000 shocks using a 15 mm applicator tip at a frequency of 5 Hz. The treatment will be conducted at an intensity of 60 mJ (1 bar), with an energy flux density of 0.340 mJ/mm².
  • Other Conventional rehabilitation
    Conventional rehabilitation will be administered for 1-2 hours daily, 5 days a week, for 12 weeks. It will include range of motion exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight shifting, balance, gait training, occupational therapy, and speech-language therapy according to the patient's needs.

Primary outcome measures

  • Modified Ashworth Scale [Time frame: Baseline, 4th week, 8th week and 12th week after treatment.]
Secondary outcome measures (5)
  • Wrist range of motion [Time frame: Baseline 4th week 8th week and 12th week after treatment.]
  • Modified Barthel Index [Time frame: Baseline, 4th week, 8th week and 12th week after treatment.]
  • The Fugl-Meyer Upper Extremity Scale [Time frame: Baseline, 4th week, 8th week and 12th week after treatment.]
  • Modified Heckmatt Scale [Time frame: Baseline, 4th week, 8th week and 12th week after treatment.]
  • Sonoelastographic strain index [Time frame: Baseline, 4th week, 8th week and 12th week after treatment.]

Eligibility criteria

Inclusion criteria

  • Age between 35 and 65 years.
  • First-ever stroke episode confirmed by MRI and/or CT scan.
  • Clinical diagnosis of hemiplegia.
  • More than 6 months post-stroke.
  • A Modified Ashworth Scale (MAS) score between 1 and 3 for wrist flexor spasticity.

Exclusion criteria

  • History of more than one stroke episode
  • Stroke onset more than ten years ago
  • Stroke onset less than 6 months ago
  • Age over 65 (to limit the effects of aging on muscle structure)
  • Contraindications for ESWT (e.g., cancer, local tumor or active infection in the treatment area, pregnancy, coagulation disorders, pacemaker or other electronic/metallic implants)
  • Severe aphasia or serious communication problems
  • Presence of fixed contracture in the wrist
  • Patients who have received botulinum toxin or phenol nerve block injections within the last 6 months
  • Medically unstable patients (e.g., uncontrolled hypertension, diabetes mellitus, or severe cardiac, hepatic, or renal disease)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Pamukkale University — Denizli

Identifiers

NCT: NCT07119801 · PamukkaleU.ftr-MGAkıncı-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗