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

Rehaklinik Zihlschlacht AG

Status

Completed

Conditions

Brain Ischemia

Intracranial Haemorrhage

Treatments

Device: Andago V2.0

Study type

Interventional

Funder types

Other

Identifiers

NCT02735460

RZI_01_2015

Details and patient eligibility

About

Andago V2.0 is a recently developed overground gait and balance training device. Many patients in neurorehabilitation suffer from gait disorders, most typically after stroke. Since pharmacological therapies are basically not available, neurorehabilitation plays an important role in the treatment of such patients. The Andago V2.0 may represent a useful device in the rehabilitation of stroke and other neurological patients featuring a severe gait disorder. Therefore a study has been designed to investigate the usability of the Andago V2.0 in the setting of a neurorehabilitation clinic. The primary outcomes of this study are the usability and acceptance of the investigational medical device (IMD). Usability is mainly measured by the time spent for the set-up and release of the participant, achieved training times and distances, the number of stumbles, collisions and emergency stops and the error messages during the session. Besides patient and therapist satisfaction with the Andago V2.0 is recorded.

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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