NCT02735460

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

Single-center Usability Study of the Overground Gait and Balance Training Device Andago V2.0 in Patients With Gait Disorder After Stroke at a Center for Neurological Rehabilitation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Rehaklinik Zihlschlacht AG · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Brain Ischemia
• Intracranial Haemorrhage

Interventions

Type	Name	Description
DEVICE	Andago V2.0	The Andago V2.0 is tested in 2 sessions, the first being a training session to define the probably optimal settings for the subsequent therapy session. In the therapy session the participant performs a specific parcours. Usually this parcours can be done within 10 minutes. However, the session is stopped as soon as the patient feels too exhausted or becomes too weary.

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-02-03
• Completion: 2017-02-03
• First posted: 2016-04-12
• Last updated: 2018-10-01

Locations

1 site across 1 country: Switzerland