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 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 12:46 AM
NCT ID:
NCT05359367
Eligibility Criteria:
Inclusion Criteria:
* Participants with hemiplegia, dependence in ambulation (1- 4 according to the Functional Ambulation Categories (FAC)),
* \>= 50 points on the Trunk Control Test.
* Impaired dorsiflexion manifested as impaired voluntarily dorsiflexion and inability to hold the ankle in a dorsiflexed position while sitting, and for ambulatory participants, impaired dorsiflexion during swing phase and initial contact during visual inspection of gait.
* Recommended for an ancle foot orthosis (AFO) by an experienced physiotherapist. Able to understand study information and provide informed consent.
Exclusion Criteria:
* Contracture that severely restricts gait movements in a lower limb joint,
* cardiovascular or other somatic condition incompatible with intensive gait training,
* notifiable infectious disease, contagious infections (e.g. MRSA or ESBL)
* Inability to participate in the rehabilitation intervention due to behavioral or psychiatric disorder
* when magnetic resonance imaging will be performed, additional exclusion criteria are current or history of epilepsy, metal implants in the brain/skull cochlear implants, any implanted neurostimulator, cardiac pacemaker or cardiac implants of metal and infusion device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05359367
Study Brief:
Protocol Section:
NCT05359367