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

Recruiting

Phase 2 Results N/A

Trial Description

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

Interventions

  • Andago V2.0 Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Treatment arm
    Description: In this arm the Andago V2.0 is used.

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Usability of the IMD according to the number of participants that are able to use the Andago V2.0 3 weeks Yes
Primary Acceptance of the IMD as measured by a therapist satisfaction questionnaire 3 weeks No
Primary Acceptance of the IMD as measured by a patient satisfaction questionnaire 3 weeks No

Sponsors