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

September 27, 2018 updated by: Rehaklinik Zihlschlacht AG

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zihlschlacht, Switzerland
        • Rehaklinik Zihlschlacht, Center for Neurological Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment arm
In this arm the Andago V2.0 is used.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Usability of the IMD according to the number of participants that are able to use the Andago V2.0
Time Frame: 3 weeks
3 weeks
Acceptance of the IMD as measured by a therapist satisfaction questionnaire
Time Frame: 3 weeks
3 weeks
Acceptance of the IMD as measured by a patient satisfaction questionnaire
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rehaklinik Zihlschlacht AG

Investigators

  • Principal Investigator: Detlef Marks, Rehaklinik Zihlschlacht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

February 3, 2017

Study Completion (Actual)

February 3, 2017

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

April 6, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

October 1, 2018

Last Update Submitted That Met QC Criteria

September 27, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RZI_01_2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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