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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT02735460
Eligibility Criteria:
Inclusion Criteria:
* Informed consent as documented by signature
* Primary diagnosis of cerebral infarction (ICD-10: I63.0-I63.9) or intracerebral haemorrhage (ICD-10: I61.0-I69.9) independent of its location, age or cause
* Gait disorder defined by a category of 1 to 3 on the Functional Ambulation Classification (FAC) (17)
* Age above 18 years
* Admission to Rehaklinik Zihlschlacht for in-patient neurorehabilitation
Exclusion Criteria:
* Inability of the participant to understand the informed consent or to follow the procedures of the study, e.g., due to language problems, psychiatric disorders, cognitive impairment or aphasia (item 9 of the National Institute of Health Stroke Scale (NIHSS) ≥2)
* Weight \>135 kg
* Height \>200 cm
* Bone fragility (e.g., non-consolidated fractures or osteotomies including craniotomies, osteopenia, osteoporosis or symptoms or indices in the patient history that infer a higher risk of bone density reduction)
* Unstable arthroplasty
* Uncontrolled knee or ankle instability that would still pose a danger despite the Body Weight Support (BWS) (especially lateral instability)
* Lack of head control
* Joint contractures
* Relevant differences in leg length
* Skin lesions (including pressure sores or enteric stomata) in areas of contact with harness support or lower extremity loading (feet)
* Relevant sensory impairment in the lower limbs and trunk, especially with reduced pain sensation
* Recent history or significant risk of seizures
* Relevant cardiovascular conditions, e.g., cardiac insufficiency and thoracotomy, uncontrolled orthostatic hypotension or other circulatory problems, vascular disorders of the lower limbs
* Mechanical ventilation
* Long-term infusions (e.g., baclofen pump, other intrathecal pumps)
* Any medical condition preventing active rehabilitation and/or the use of the Andago V2.0 (e.g., respiratory disease, pregnancy, orthopedic conditions, infections or inflammatory disorders, osteomyelitis)
* Participation in another interventional study within the 30 days preceding and during the present study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02735460
Study Brief:
Protocol Section:
NCT02735460