Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-27 @ 5:10 PM
Study NCT ID:
NCT02735460
Status:
COMPLETED
Last Update Posted:
2018-10-01
First Post:
2016-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Usability of Andago V2.0 in Gait Rehabilitation of Stroke Patients
Sponsor:
Rehaklinik Zihlschlacht AG
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: