Optimal Dose of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity
NCT ID: NCT02358005
Last Updated: 2019-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2015-02-28
2019-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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60mJ ESWT
ESWT (0.04 mJ/mm2, 1500 shock + sham stimulation 2500) / total dose per treatment : 60mJ
Extracorporeal shock wave therapy 60mj
120mJ ESWT
ESWT (0.04 mJ/mm2, 4000 shock) / total dose per treatment : 160mJ
Extracorporeal shock wave therapy 120mj
sham ESWT stimulation
ESWT (0 mJ/mm2, sham stimulation 4000) / total dose per treatment : 0mJ
non extracorporeal shock wave therapy
Interventions
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Extracorporeal shock wave therapy 60mj
Extracorporeal shock wave therapy 120mj
non extracorporeal shock wave therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Yonsei University Healthcare System, Severance Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4-2014-0925
Identifier Type: -
Identifier Source: org_study_id
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