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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Turkey
Pamukkale University
RECRUITING
Denizli
Contact Information
Primary
Meltem Güneş Akıncı, Assistant professor
meltem_aytekin@hotmail.com
+905375145590
Time Frame
Start Date: 2025-09-05
Estimated Completion Date: 2026-08-20
Participants
Target number of participants: 32
Treatments
Active_comparator: Conventional group
This group will receive physical therapy for 1-2 hours daily, 5 days a week, for 12 weeks. The therapy will include range of motion (ROM) exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight-bearing exercises, balance and gait training, and occupational therapy. Speech and language therapy will also be included according to the patient's needs.
Experimental: radial ESWT (rESWT) plus conventional rehabilitation group
The rESWT will be applied to the Flexor Carpi Ulnaris (FCU) and Flexor Carpi Radialis (FCR) muscles twice a week for four weeks, totaling eight sessions. The application site will be the midpoint of the most prominent part of each muscle. For each muscle, a 15 mm applicator head will be used to deliver 2000 impulses at a frequency of 5 Hz and an intensity of 60 mJ (1 bar), corresponding to an energy flux density of 0.340 mJ/mm². Additionally, this group will receive physical therapy for 1-2 hours daily, 5 days a week, for 12 weeks. The therapy will include range of motion (ROM) exercises, stretching exercises, progressive resistive exercises, positioning, postural control, weight-bearing exercises, balance and gait training, and occupational therapy. Speech and language therapy will also be included according to the patient's needs.
Sponsors
Leads: Pamukkale University

This content was sourced from clinicaltrials.gov