Extracorporeal Shock Wave Therapy in Botulinum Toxin-Treated Patients With Post-Stroke Ankle Plantar Flexor Spasticity

Condition(s) studied

Investigational drug(s) / intervention(s)

Radial Extracorporeal Shock Wave Therapy (rESWT): Applied 1 week after the routine Botulinum Toxin Type A (BoNT-A) injection. Patients receive 3 sessions (once a week for 3 weeks) of rESWT to the medial and lateral heads of the gastrocnemius muscle in the prone position with knee in full extension and ankle in neutral. Dose parameters: 2000 pulses per session, 5 Hz frequency, and 60 mJ (1 bar) energy level using a 15 mm transmitter head (calculated energy flux density: 0.340 mJ/mm²).

Conventional Physical Therapy and Rehabilitation: A 3-week comprehensive rehabilitation program performed 2-3 hours per day, 5 days a week. The program includes passive/active range of motion exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight-shifting, balance training, gait training, occupational therapy, and speech therapy based on individual patient needs.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change from Baseline in Muscle Spasticity Grade using the Modified Ashworth Scale (MAS) — Baseline, Week 3 (Post-treatment), and Week 12 (Follow-up)
  The MAS is a clinical scale used to assess resistance to passive movement in a joint affected by spasticity. Scores range from 0 to 4 (with an additional 1+ score), where 0 indicates no increase in muscle tone and 4 indicates the affected part is rigid in flexion or extension. Higher scores represent greater muscle spasticity.

Trial sites (1)

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