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:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-24 @ 4:21 PM
NCT ID:
NCT03659266
Eligibility Criteria:
Inclusion Criteria:
* Age between 18 and 80 years
* Left or right spastic hemiparesia after a single unilateral hemorrhagic or ischemic stroke, in chronic phase (at least 6 months after stroke)
* Functional hindrance in walking
* Spasticity of paretic triceps surae allowing for focal treatment by Botulinum toxin injection
Exclusion Criteria:
* Inability to walk with or without technical aids \>5min
* Cognitive disorders disallowing informed consent
* Spasticity equal or superior to 4 on the triceps surae (On the Modified Ashworth Scale)
* Physical exercise not allowed: non stable cardiovascular or pulmonary disease in particular
* Lokomat® use not allowed: cutaneous lesions that could come in contact with the straps, non consolidated recent fracture (\<3months), severe disability in controlling trunk balance disallowing correct posture in Lokomat®, intra-abdominal cranial flap, weight\>135kg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03659266
Study Brief:
Protocol Section:
NCT03659266