Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT02358005
Eligibility Criteria:
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* Participant who should be withdrawn from the study in the opinion of the investigator for any reason
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02358005
Study Brief:
Protocol Section:
NCT02358005