Post-Stroke Elbow Spasticity
Conditions
Brief summary
Recently, It is known that the efficacy of botulinum toxin type A (BTX-A) with extracorporeal shock wave therapy (ESWT) is greater than that of BTX-A with electrical stimulation in the management of post-stroke spasticity of the upper limb. However, it was not determined which dose of ESWT is optimal as a adjuvant therapy after BTX-A injection on the upper limb in patients with stroke. Therefore, the aim of this study is to evaluate the optimal dose of ESWT after botulinum toxin type A injection for post-stroke spasticity
Interventions
PROCEDUREExtracorporeal shock wave therapy 60mj
PROCEDUREExtracorporeal shock wave therapy 120mj
PROCEDUREnon extracorporeal shock wave therapy
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female * Age ≥20 years * inpatients * Elbow flexor spasticity in patients, confirmed to be mainly due to biceps brachii * Modified Ashworth scale (MAS) ≥2, * At least a 3-month period from stroke, * Written informed consent has been obtained
Exclusion criteria
* Fixed contractures and/or deformities at the elbow, * Previous fractures of the paretic upper limb, * Peripheral nervous system disorders/myopathies, * Previous BTX-A treatment and/or ESWT, * Structural alterations in the soft tissue (e.g., fibrosis), * Known allergy or sensitivity to the study medication or its components * Presence of an unstable medical condition or uncontrolled systemic disease * Any medical condition that may put the patient at increased risk with exposure to botulinum toxin therapy. (ex. Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interface with neuromuscular function. * Bleeding tendency and/or anticoagulation therapy * Presence of infection or skin disorder at injection sites * Females were are pregnant, nursing, or are planning a pregnancy during the study * Females of child-bearing potential (including pre-menstrual woman), not using a reliable means of contraception * Participant who should be withdrawn from the study in the opinion of the investigator for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Range of Motion (ROM) of elbow flexor | 5 weeks |
Countries
South Korea
Contacts
Primary ContactYong Wook Kim, MD
Outcome results
None listed