Effectiveness of Extracorporeal Shock Wave Therapy as an Adjunct to Botulinum Toxin Injection in Patients With Post-Stroke Ankle Plantar Flexor Spasticity: A Randomized Controlled Trial
| Registry | NCT07695038 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 32 (Estimated) |
| Sponsor | Pamukkale University (Other) |
| Conditions | Stroke, Post-stroke Spasticity of the Lower Limb, Post-Stroke Spasticity, Spasticity of the Plantar Flexors, Spasticity, Post-Stroke |
| Interventions | Radial Extracorporeal Shock Wave Therapy (rESWT), Conventional Physical Therapy and Rehabilitation (Device, other) |
| Dates | start 2026-07-20 (estimated), primary completion 2027-07-20 (estimated), completion 2027-08-20 (estimated), first posted 2026-07-10, last updated 2026-07-10 |
| Locations | 1 site in Turkey (Türkiye) |
Related Papers Related Patents Related Grants Related Experts
All trials for Stroke All trials for Post-stroke Spasticity of the Lower Limb All trials of Radial Extracorporeal Shock Wave Therapy (rESWT) All trials of Conventional Physical Therapy and Rehabilitation
The goal of this clinical trial is to learn if radial Extracorporeal Shock Wave Therapy (rESWT) is effective in reducing ankle plantar flexor spasticity and improving walking functions in stroke patients who have already received Botulinum Toxin type A (BoNT-A) injections. The main questions it aims to answer are:
* Does adding rESWT to standard physical therapy significantly lower muscle spasticity in patients who have received BoNT-A, compared to receiving physical therapy alone after the injection?
* Does combining rESWT with BoNT-A injection improve functional walking parameters (such as gait speed, cadence, and step length) and daily life independence more than the BoNT-A and physical therapy combination alone?
* Can rESWT induce additional structural and flexibility improvements in the BoNT-A injected gastrocnemius muscle, as measured objectively by ultrasound imaging and strain elastography?
Researchers will compare a group of participants receiving both rESWT and conventional physical therapy (Group 1) to a comparison group receiving only conventional physical therapy (Group 2) to see if rESWT provides additional clinical benefits. All participants in both groups will have already undergone routine BoNT-A injections one week prior to starting the study treatments.
Participants will:
* Undergo a 3-week conventional physical therapy and rehabilitation program, consisting of 2 to 3 hours of therapy per day, 5 days a week.
* Receive 3 weekly sessions of rESWT (2000 pulses per session applied to the calf muscles) if they are randomized into the rESWT group.
* Attend clinical evaluation visits and objective assessment sessions-including high-tech computerized gait analysis and specialized musculoskeletal ultrasound imaging-before the treatment, at the end of the 3rd week, and at a 12-week follow-up.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| rESWT + Physical Therapy | Experimental | Device: Radial Extracorporeal Shock Wave Therapy (rESWT); Other: Conventional Physical Therapy and Rehabilitation | Patients receive routine BoNT-A injection, followed by 3 weekly sessions of radial Extracorporeal Shock Wave Therapy (rESWT) and a 3-week conventional physical therapy program. |
| Physical Therapy Alone | Active comparator | Other: Conventional Physical Therapy and Rehabilitation | Patients receive routine BoNT-A injection, followed only by a 3-week conventional physical therapy program without rESWT. |
Sex: All, ages: 18 Years to 65 Years
Inclusion Criteria: * Diagnosis of stroke according to the World Health Organization (WHO) (1989) definition. * Stroke diagnosis confirmed by magnetic resonance imaging (MRI). * Patients aged between 18 and 65 years. * Clinically stable condition after stroke. * Patients who have undergone routine Botulinum Toxin Type A (BoNT-A) injection to the gastrocnemius muscle. * Presence of ankle plantar flexor spasticity with a Modified Ashworth Scale (MAS) score of greater than or equal to 1 (MAS ≥ 1). Exclusion Criteria: * Presence of fixed contracture at the ankle joint. * History of prior antispastic surgical procedures. * Changes in antispastic medication dosage or type within the last 6 months. * Active infection or malignancy at the application site. * Presence of a cardiac pacemaker. * Bleeding disorders or advanced vascular disease. * Pregnancy. * Presence of neuromuscular junction disease or motor neuron disease. * Known allergy or hypersensitivity to Botulinum Toxin Type A. * Current use of antibiotics.
| Facility | City | Country | Status |
|---|---|---|---|
| Pamukkale University Faculty of Medicine, Department of Physical Medicine and Rehabilitation | Denizli, Denizli | Turkey (Türkiye) |