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 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT06940635
Eligibility Criteria:
Inclusion Criteria:
* Age: Participants must be aged 18 years or older.
* Post-Stroke Phase: Participants must be within the chronic post-stroke phase (time since ischemic or haemorrhagic stroke greater than 3 months).
* Motor Impairment: Participants must exhibit disabling left or right residual arm paresis ("left/right arm motor drift" part of the NIHSS score ≥1).
* Speech/Swallowing Impairment: Participants must have:
* Aphasia (AAT-Skala zum Kommunikationsverhalten score ≤3), and/or
* Dysphagia (MUCCS-N score ≥2).
* Stable Neurological Status: No relevant changes in neurological status in the past 4 weeks (self-reported).
* Motor Function: Participants must be able to raise at least 1 block similar to the ones in Box-and-Block-Test.
* Cognitive Understanding: Participants must be able to understand basic spoken instructions.
* Sitting Tolerance: Participants must be able to maintain a sitting position for at least 60 minutes.
* Willingness to Participate: Participants must be willing to participate in the study and able to understand and sign the informed consent.
Exclusion Criteria:
* Cognitive Impairments: Cognitive impairments that, in the investigator's judgment, could limit understanding of task instructions.
* Stroke Location: Participants with a brainstem and/or cerebellar stroke.
* Previous Stroke: Participants with a previous disabling stroke.
* Hemi-Neglect: Pronounced hemi-neglect at the last documented therapy visit that limits compliance with treatment intervention (investigator's judgment).
* Anosognosia: Pronounced anosognosia at the last documented therapy visit that limits compliance with treatment intervention (investigator's judgment).
* Spasticity: Severe spasticity in the affected limb, resulting in complete rigidity in flexion or extension.
* Seizure Disorders: Participants with uncontrolled epilepsy (investigator's judgement) or epileptic seizure within the last month.
* Intracranial Pressure: Known ongoing elevated intracranial pressure.
* Implanted Medical Devices: Participants with implanted medical devices with contraindication for FES such as pacemakers.
* Metallic Fragments: Participants with implanted metallic fragments in the extremity planned for FES that would limit the use of functional electrical stimulation (FES).
* Unhealed Injuries: Unrecovered fractures or skin/tissue lesions in the FES stimulated extremity.
* Joint Issues: Ossification, contraction, or stiffness of the wrist joint in the FES stimulated extremity that would limit treatment.
* Botulinum Toxin: Participants who received botulinum-toxin treatment within 6 weeks prior to study inclusion and/or for whom botulinum-toxin treatment is planned during the study duration.
* Co-morbidities: The following conditions will exclude participation:
* Chronic Obstructive Pulmonary Disease (Stage IV).
* Cardiac insufficiency (NYHA Stage IV).
* Severe acute infections.
* Significant circulatory disturbances in the stimulated extremity.
* Sensory disorders that significantly impair the patient's ability to feel pain or react to unsuitable proprioceptive stimuli.
* Any other general medical conditions that, in the investigator's judgment, limit the safety or performance of study procedures (investigator's judgement).
* Electrical Stimulation Intolerance: Known inability to tolerate cutaneous electrical stimulation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06940635
Study Brief:
Protocol Section:
NCT06940635