Usability of Andago V2.0 in Gait Rehabilitation of Stroke Patients


Phase 2 Results N/A

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