NCT07119801

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Pamukkale University · Academic / Other
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stroke
• Spastic Hemiplegia
• Extracorporal Shockwave Therapy (ESWT)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-05
• Primary completion: 2026-04-20
• Completion: 2026-08-20
• First posted: 2025-08-13
• Last updated: 2025-09-29

Locations

1 site across 1 country: Turkey (Türkiye)